SelfBack — Electronic Instructions for Use (eIFU)

Device name	SelfBack
UDI-DI	05700002230607
Device type	Standalone software application — Software as a Medical Device (SaMD)
Classification	Class I medical device
Classification rule	Rule 11, EU MDR 2017/745
Product identification string	1.X.X
Software version	Shown in the app under Profile > General > Legislation and Regulations
Platforms	iOS (Apple App Store), Android (Google Play Store)

2. Manufacturer Information

Legal manufacturer	SelfBack ApS
Address	Gyvelvænget 25, DK-5690 Tommerup, Denmark
CVR (Company Reg.)	41894334
SRN	DK-MF-000002519
E-mail	info@selfback.dk / support@selfback.dk
Phone (support for users)	+45 43 32 62 52 (weekdays 09:00–16:00 CET)
Phone (support for clinicians)	+45 80 83 06 09 (weekdays 09:00–16:00 CET)
Website	www.selfback.dk

To request a paper copy of these instructions for use, free of charge, contact support@selfback.dk. Paper copies will be dispatched within 7 calendar days of receipt of request, in accordance with Commission Implementing Regulation (EU) 2021/2226.

3. Intended Purpose

The intended purpose of SelfBack is to provide personalised self-management plans for adult patients (aged 18 and over) suffering from non-specific low back pain, to be followed with or without support from primary care.

SelfBack is intended to supplement — not replace — treatment from a healthcare professional (HCP). The app provides exercise programmes, educational content, and physical activity monitoring to support the patient's self-management between clinical visits.

The device is intended to be used after a healthcare professional has assessed the patient and determined that self-management with SelfBack is appropriate.

Main functions

Function	Description
Exercise Programme	Personalised strength and flexibility exercises, each with video and written instructions. Difficulty progresses or regresses based on the patient's reported completion and feedback.
Educational Content	Daily educational messages and articles tailored to the patient's condition and needs, covering self-management techniques, pain education, and lifestyle guidance.
Physical Activity Monitoring	Step count monitoring via Apple Health (iOS) or Google Fit (Android), with personalised daily step goals based on historical activity level.
Weekly Tailoring	Each week, the self-management plan is updated based on the patient's latest questionnaire responses, exercise feedback, and step count data, ensuring the plan remains appropriate for the patient's current condition.
Motivational Messages	Personalised reminders and motivational messages to support engagement and adherence to the self-management programme.
Questionnaires	Validated clinical questionnaires (baseline and weekly) that capture the patient's current condition, including pain, function, fear-avoidance, sleep, stress, and depression indicators.

5. Medical Contraindications

SelfBack must NOT be used by patients with any of the following conditions:

Unable to speak, read, or understand one of the supported languages (Arabic, Danish, German, English, Spanish, French, Norwegian, Dutch, Swedish, or Portuguese)
Cognitive impairments or learning disabilities limiting participation
Mental or physical illnesses or conditions limiting participation, as assessed by the referring healthcare professional or participant
Inability to take part in exercise or physical activity
Fibromyalgia (diagnosed by a healthcare professional)
Pregnancy
Previous back surgery
Ongoing participation in other research trials for low back pain management

A healthcare professional should assess whether the patient is suitable for SelfBack before the patient begins using the app.

User group	Description
Patients (primary user)	Adults aged 18 and over with non-specific low back pain, who own a smartphone with internet access. Patients use the app independently for daily self-management. No medical training is required.
Healthcare professionals (referring user)	Clinicians who assess patient suitability, prescribe SelfBack, and provide initial introduction to the app.

7. Clinical Benefits

The following clinical benefits are expected from using SelfBack, based on the evidence from the SelfBack randomised controlled trial (RCT):

Improved self-management — Patients receive structured, evidence-based self-management support that supplements clinical care, increasing their involvement in their own treatment
Personalised treatment — The case-based reasoning system tailors exercise programmes, educational content, and activity goals to each patient's individual profile and ongoing condition
Improved adherence — Weekly plan updates and motivational support promote consistent engagement with the self-management programme
Evidence-based content — All exercises and educational content are based on clinical guidelines for non-specific low back pain management, reviewed and approved by clinical experts

These benefits are supported by a published randomised controlled trial in JAMA Internal Medicine (2021), which demonstrated statistically significant improvements at 3 months in pain intensity, pain self-efficacy, illness perception, and global perceived effect. Five secondary analyses confirmed that these benefits are consistent across patient subgroups regardless of age, gender, education, pain duration, multimorbidity, depression, stress, or physical work demands. A cost-effectiveness analysis (BMJ Open, 2024) found SelfBack to be cost-effective in addition to usual care.

8. How the Device Works (Performance Characteristics)

SelfBack uses case-based reasoning (CBR) to generate personalised self-management plans. CBR is a methodology that solves new problems by finding and adapting solutions from similar past cases.

How the recommendation process works

Data collection — The patient completes a baseline questionnaire covering pain, function, fear-avoidance, sleep, stress, and depression indicators. Weekly tailoring questionnaires capture updated condition data. Step count data is collected from Apple Health or Google Fit. Exercise completion and feedback are recorded.
Case matching — The CBR system compares the patient's current profile against a validated case base derived from the SelfBack RCT. It identifies the most similar past cases using weighted similarity measures across multiple clinical attributes.
Plan generation — Based on the matched cases and clinical rules, the system selects an exercise programme (3–5 sessions per week, approximately 15 minutes per session) with an appropriate difficulty level (levels 1–6), educational content relevant to the patient's specific needs, and a personalised daily step-count target.
Weekly adaptation — Each week, the plan is regenerated using the patient's latest data. If the patient reports a pain flare-up, pain-relief exercises are recommended instead of strength and flexibility exercises. Exercise difficulty adjusts based on reported completion (maximum change of ±1 level per week).
Safety limits — The system enforces clinical thresholds validated in the RCT to detect changes in the patient's condition, including pain levels, fear-avoidance, depression, stress, sleep quality, and work capacity.

The content for SelfBack was developed using an intervention mapping process, reviewed by patients and clinicians, and tested in feasibility studies and a pilot study before the RCT version was finalised.

9. Instructions for Installation and Use

Installation

Download SelfBack from the Apple App Store (iOS) or Google Play Store (Android)
Open the app and follow the on-screen registration process
When prompted, grant SelfBack access to Apple Health (iOS) or Google Fit (Android) for step count tracking
Complete the baseline questionnaire as instructed by your healthcare professional
Your first personalised self-management plan will be generated after completing the baseline questionnaire

Always use the latest version of SelfBack available in the App Store or Google Play. Updates may include important safety and functionality improvements.

Correct use

To get the best results from SelfBack:

Answer questionnaires honestly and accurately — Your self-management plan is generated based on your responses. Inaccurate answers may lead to a plan that does not match your actual condition.
Complete the weekly tailoring questionnaire — This ensures your plan is updated to reflect your current condition.
Follow the recommended exercise programme — Perform exercises as demonstrated in the video instructions. If an exercise causes significant pain, stop and report it via the feedback mechanism.
Report exercise completion and feedback — This allows the system to adjust exercise difficulty appropriately.
Wear or carry your smartphone — Step count tracking requires the phone to be on your person or connected to a wearable device that syncs with Apple Health or Google Fit.
Use SelfBack regularly — The app is designed to provide ongoing weekly support. Returning after a long absence will trigger a new tailoring session to reassess your condition.

10. Warnings, Precautions, and Limitations

Warnings

SelfBack does NOT replace professional medical care. The app is designed to supplement — not replace — care from your healthcare professional. Continue to follow your healthcare professional's advice and attend scheduled appointments.

Do not use SelfBack if you have any of the contraindications listed in Section 5. If you are unsure whether SelfBack is appropriate for you, consult your healthcare professional before using the app.

Stop exercising immediately and consult your healthcare professional if you experience:

Sudden, severe increase in pain
Pain that spreads down your leg(s), especially below the knee
Numbness, tingling, or weakness in your legs
Difficulty controlling your bladder or bowels
Fever combined with back pain
Unexplained weight loss combined with back pain

Do not share your account with another person. The self-management plan is personalised to your clinical profile. Another person using your account would receive a plan that is not appropriate for their condition and could be harmful.

Precautions

Temporary pain increase — Starting a new exercise programme may cause temporary muscle soreness or mild pain increase. This is normal and typically resolves within a few days. If pain persists or worsens, reduce exercise intensity and consult your healthcare professional.
Incorrect self-assessment — If you are unsure how to answer a questionnaire question, ask your healthcare professional for guidance. Incorrect answers may result in a plan that does not match your condition.
Exercise form — Always watch the exercise video demonstration before performing an exercise for the first time. Incorrect exercise form may increase the risk of injury.

Limitations

SelfBack is designed for non-specific low back pain only. It is not suitable for low back pain with a specific diagnosis (e.g. spinal fracture, infection, tumour, nerve root compression requiring surgery).
The app requires an active internet connection to receive updated self-management plans. Exercises and educational content that have already been downloaded remain available offline.
SelfBack does not provide real-time clinical monitoring. The app does not detect medical emergencies.
The quality of personalisation depends on the accuracy and completeness of the information you provide through questionnaires and exercise feedback.

11. When to Consult a Healthcare Professional

Contact your healthcare professional or seek medical attention immediately if you experience any of the following while using SelfBack:

Leg weakness or numbness — Loss of strength or feeling in one or both legs
Bladder or bowel problems — Difficulty controlling urination or bowel movements, or loss of sensation in the area around your genitals or buttocks
Severe or worsening pain — Pain that is significantly worse than usual, or pain that does not improve with rest
Pain spreading down your legs — Pain that travels below your knee, especially if accompanied by numbness or tingling
Fever with back pain — Fever (temperature above 38°C) combined with back pain
Unexplained weight loss — Unintended weight loss combined with back pain
Pain after an accident or injury — Back pain following a fall, car accident, or other trauma
Night pain — Pain that wakes you at night and is not related to your sleeping position

These symptoms may indicate a condition that requires prompt medical investigation and is outside the scope of self-management with SelfBack.

SelfBack is designed to supplement your healthcare professional's care. If your condition is not improving after several weeks of use, or if you have any concerns about your symptoms, consult your healthcare professional.

SelfBack is not an emergency service. In a medical emergency, call your local emergency number.

12. Residual Risks and Undesirable Side Effects

The following residual risks have been identified through the ISO 14971 risk management process. All risks have been reduced to acceptable levels through risk control measures.

Risk	Description	What you should do
Temporary pain increase	Starting a new exercise programme or progressing to harder exercises may cause temporary muscle soreness or mild pain increase.	This is normal and usually resolves in a few days. If pain persists beyond a few days or worsens, reduce activity and consult your healthcare professional.
Inappropriate plan from inaccurate self-assessment	If questionnaire responses do not accurately reflect your condition, the generated plan may not be optimal.	Answer all questionnaires honestly and to the best of your ability. If unsure about a question, ask your healthcare professional.
Delayed professional consultation	Relying solely on SelfBack may delay seeking necessary professional care for a worsening condition.	Follow the guidance in Section 11. If your condition worsens or red-flag symptoms appear, seek medical attention regardless of the app's recommendations.
Exercise injury from incorrect form	Performing exercises without following the video instructions may lead to incorrect form and potential injury.	Always watch the video demonstration before performing an exercise for the first time. Stop any exercise that causes significant or unexpected pain.
Stale plan after absence	Returning to the app after a long period of inactivity may initially present an outdated plan before re-tailoring.	Complete the re-tailoring questionnaire when prompted upon returning to the app.
Service unavailability	Server outages or connectivity issues may temporarily prevent access to updated plans.	Previously downloaded exercises and educational content remain available offline. If the app is unavailable for an extended period, continue your last recommended exercises at a comfortable level and contact support if the issue persists.

13. IT Requirements and Security

Minimum device requirements

Requirement	Specification
iOS	iOS 15.1 or later
Android	Android 7.0 (API level 24) or later
Device type	Smartphone or tablet
Storage	Sufficient space for the app and cached content (approximately 200 MB)
Internet	Active internet connection required for initial setup, weekly plan updates, and content synchronisation. Previously downloaded content is available offline.
Health platform	Apple Health (iOS) or Google Fit (Android) must be installed for physical activity monitoring.

Data protection and security

Encryption in transit — All data transmitted between the app and SelfBack servers is encrypted using TLS 1.2 or later
Encryption at rest — Patient data stored on SelfBack servers is encrypted at rest
Secure token storage — Authentication tokens are stored in the operating system's secure storage (iOS Keychain / Android Keystore), not accessible to other apps
Authentication — Access to your account requires verification via one-time password (OTP) sent to your registered phone number
Data residency — EU patient data is processed and stored within the European Union (AWS eu-west-1, Ireland). Canadian patient data is stored in Canada (AWS ca-central-1).
Access control — Only authorised SelfBack personnel with a legitimate purpose can access patient data, subject to audit logging

Protecting your account

Do not share your login credentials or one-time passwords with anyone
Keep your smartphone's operating system up to date
Use a screen lock (PIN, fingerprint, or face recognition) on your device
Download SelfBack only from the official Apple App Store or Google Play Store
Do not use SelfBack on jailbroken or rooted devices

14. Data Protection and Account Management

What data SelfBack collects

Account information — Phone number, name, date of birth
Clinical questionnaire responses — Pain, function, fear-avoidance, sleep, stress, depression indicators
Exercise feedback — Completion status, reported difficulty, pain reports
Physical activity data — Daily step count from Apple Health or Google Fit
Usage data — App usage patterns for service improvement (anonymised)

Your data rights (GDPR)

Under the General Data Protection Regulation (GDPR), you have the right to:

Access your personal data — Available in the app under Profile
Delete your account and all associated data — Available in the app under Profile > Account > Delete Account
Data portability — Request a copy of your data by contacting support@selfback.dk
Withdraw consent — You may stop using SelfBack at any time by deleting your account

For the full privacy policy, see the Privacy Policy accessible within the app (Profile > Legal), or at selfback.app/en/privacy-policy.

Deleting your account

Open SelfBack
Go to Profile > Account > Delete Account
Confirm your identity by entering your phone number
Confirm the deletion

Account deletion is permanent. All your data, including exercise history and treatment plans, will be removed and cannot be recovered.

15. Troubleshooting

Problem	What to do
App will not open or crashes	Close the app completely and reopen it. If the problem persists, ensure you have the latest version installed from the App Store or Google Play. Restart your phone if necessary.
Cannot log in	Check that you are using the correct phone number. Ensure you have an active internet connection. If you do not receive a one-time password, check that your phone number is entered correctly including country code, and try again after a few minutes.
Exercises not loading	Check your internet connection. If you are offline, only previously downloaded exercises will be available. Connect to the internet to download new content.
Step count not updating	Ensure SelfBack has permission to access Apple Health (iOS) or Google Fit (Android) in your phone's settings. Verify that Apple Health or Google Fit is recording your step data.
Plan not updating	Complete the weekly tailoring questionnaire to receive an updated plan. A new plan is generated each week after you complete the questionnaire.
App behaves unexpectedly	Update to the latest version. If the issue persists, contact SelfBack support with a description of the problem.

If you experience a problem not listed above, contact SelfBack support at support@selfback.dk or +45 43 32 62 52 (weekdays 09:00–16:00 CET).

16. Reporting Serious Incidents

If a serious incident occurs in relation to your use of SelfBack, you must report it to the manufacturer and to your national competent authority.

Report to the manufacturer

Contact SelfBack ApS immediately:

E-mail: support@selfback.dk
Phone: +45 43 32 62 52 (weekdays 09:00–16:00 CET)

Please include:

Your name and contact details
A description of what happened
When it happened
The app version (found under Profile > General > Legislation and Regulations)
Your device type and operating system version

Report to your national competent authority

Under EU MDR 2017/745 Article 87, users and healthcare professionals should also report serious incidents to the competent authority in the Member State where the incident occurred.

For incidents in Denmark, report to:

Lægemiddelstyrelsen (Danish Medicines Agency)
Website: https://laegemiddelstyrelsen.dk
E-mail: dkma@dkma.dk

For other EU/EEA Member States, contact the relevant national competent authority for medical devices. A list is available at health.ec.europa.eu.

A serious incident is any incident that directly or indirectly led, might have led, or might lead to the death of a patient, user, or other person, or to a serious deterioration in their state of health, or a serious public health threat.

17. Combination with Other Devices

SelfBack does not connect to other medical devices. However, SelfBack integrates with the following health platforms for physical activity monitoring:

Apple Health (iOS) — SelfBack reads step count data from Apple Health. Apple Health may receive step data from the iPhone's built-in sensors or from connected third-party devices such as smartwatches or activity trackers.
Google Fit (Android) — SelfBack reads step count data from Google Fit. Google Fit may receive step data from the phone's built-in sensors or from connected third-party devices.

SelfBack does not control or influence the operation of any third-party devices. The accuracy of step count data depends on the device and health platform used.

18. User Training and Qualifications

No special training or medical knowledge is required to use SelfBack.

The intended workflow is:

A healthcare professional assesses the patient and determines that self-management with SelfBack is appropriate
The healthcare professional or clinical staff provides a brief introduction to the app
The patient receives a patient information flyer with instructions for getting started (available for both Android and iOS)
The patient installs and uses SelfBack independently

Healthcare professionals receive an introduction to SelfBack through the SelfBack organisation. Contact info@selfback.dk for clinician onboarding materials.

19. Storage, Transport, and Durability

SelfBack is software and has no physical storage, transport, or durability requirements. Sterilisation, cleaning, and disinfection are not applicable.

The app is available for download from the Apple App Store and Google Play Store
Always use the latest version of the app
The manufacturer will notify users through the app or via the app stores when updates are available
SelfBack supports the current and two previous major OS versions (currently iOS 15.1+ and Android 7.0+). When a new major OS version is released, support for the oldest version may be dropped with a subsequent SelfBack update.
Users will receive at least 3 months' notice before support for an OS version is dropped, via in-app notification and app store release notes.
After end of support, the app may continue to function but will no longer receive updates, bug fixes, or security patches. Users on unsupported OS versions are advised to update their device.
If SelfBack is discontinued entirely, users will receive at least 3 months' notice and instructions for deleting their account and data.

20. Identification and Labelling

Identifying your app version

To view the app version and regulatory information:

Open SelfBack
Go to Profile > General > Legislation and Regulations

This screen displays the app version number (major.minor.hotfix) and build number, CE marking status (Class I Medical Device), the UDI-DI identifier, GDPR compliance status, applicable standards (IEC 62304, IEC 62366-1, ISO 13485, ISO 14971), and the manufacturer name and address.

Version numbering

The SelfBack version number follows the format X.Y.Z where:

X (major) — Significant changes to intended purpose, safety, or performance
Y (minor) — New features or enhancements
Z (hotfix) — Bug fixes and minor corrections

22. Regulatory Information

CE SelfBack bears the CE marking in accordance with EU MDR 2017/745.

Regulation	Regulation (EU) 2017/745 on medical devices (EU MDR)
Device class	Class I
Classification rule	Rule 11 (software intended to provide information used to take decisions with diagnosis or therapeutic purposes)
Conformity assessment	Self-certified by the manufacturer per Annex IV (EU Declaration of Conformity). No Notified Body is required for Class I devices.
UDI-DI	05700002230607
SRN	DK-MF-000002519

Applicable standards

ISO 13485:2016 — Medical devices — Quality management systems
ISO 14971:2019 — Medical devices — Application of risk management to medical devices
IEC 62304:2006+A1:2015 — Medical device software — Software life cycle processes
IEC 62366-1:2015+A1:2020 — Medical devices — Application of usability engineering to medical devices

eIFU compliance

These electronic instructions for use are provided in accordance with Commission Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices. As SelfBack is software, the eIFU is provided via the device itself and on this website.

A paper copy of these instructions is available free of charge upon request. Contact support@selfback.dk; paper copies are dispatched within 7 calendar days of receipt of request.

23. Symbols and Abbreviations

CE	Conformité Européenne — indicates conformity with EU health, safety, and environmental protection legislation
UDI-DI	Unique Device Identification — Device Identifier
SRN	Single Registration Number (EUDAMED)
SaMD	Software as a Medical Device
CBR	Case-Based Reasoning
HCP	Healthcare Professional
RMDQ	Roland-Morris Disability Questionnaire
GDPR	General Data Protection Regulation (EU) 2016/679
EU MDR	European Medical Device Regulation (EU) 2017/745
eIFU	Electronic Instructions for Use

General enquiries	info@selfback.dk
User support	support@selfback.dk · +45 43 32 62 52 (weekdays 09:00–16:00 CET)
Clinician support	+45 80 83 06 09 (weekdays 09:00–16:00 CET)
Serious incident reporting	support@selfback.dk
Paper IFU requests	support@selfback.dk (dispatched within 7 days, free of charge)
Website	www.selfback.dk

Document ID	SB-eIFU-001
Version	1.0
Date of issue	2026-09-03
Source document	SB SelfBack V.1.X.X Instructions for Use, revision 1.12 (issued 2026-04-07)
Language	English

1. Device Identification