Fesera is a digital health and wellness platform providing guided, self-administered, evidence-based rehabilitation content for adults with chronic non-specific low back pain. It is not a medical device, a clinical service, or a licensed healthcare facility.
The answer, under current applicable frameworks across all our markets, is no. Here is the reasoning.
The International Medical Device Regulators Forum (IMDRF) — the global body coordinating medical device regulation — defines Software as a Medical Device (SaMD) as:
"Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
Crucially, the IMDRF framework distinguishes between software that drives or informs clinical management of a specific individual (regulated as SaMD) and software that provides general wellness information, education, or lifestyle support (not regulated as SaMD).
Fesera does not diagnose a medical condition, does not interpret imaging or lab data, does not recommend pharmaceutical treatment, and does not substitute for a healthcare professional's clinical judgment for a specific patient. It provides a structured exercise and education programme for a population that has self-screened using a validated questionnaire. This positions Fesera as a general wellness and rehabilitation tool under IMDRF guidance.
NAFDAC (National Agency for Food and Drug Administration and Control) does have regulatory authority over medical devices in Nigeria — its mandate covers food, drugs, cosmetics, medical devices, chemicals, and packaged water. However, Nigeria's regulatory framework for software-based digital health tools is still developing. NAFDAC has not yet issued specific guidance classifying general wellness or self-administered rehabilitation apps as registrable medical devices.
Fesera is not currently required to register as a medical device with NAFDAC. We monitor NAFDAC regulatory developments actively and will seek registration or compliance certification if and when Nigerian regulation requires it for software products of this type.
Under EU MDR 2017/745 and the MDCG Guidance on Qualification and Classification of Software (MDCG 2019-11), software is a medical device only if it has a medical purpose directed at a specific individual — diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease in that individual. General wellness software is not a medical device under EU MDR. Fesera falls into the general wellness category.
Under MHRA Software and AI as a Medical Device guidance (2024), Fesera's wellness and self-rehabilitation positioning aligns with MHRA's distinction between medical device software and general wellness tools. Fesera is not currently registrable as a medical device with the MHRA.
Under FDA guidance on Mobile Medical Applications and the Software as a Medical Device guidance (2023), the FDA exercises enforcement discretion over low-risk software that helps users self-manage a condition without providing specific treatment suggestions. The 21st Century Cures Act (2016) further excludes "general wellness products" from FDA medical device oversight. Fesera falls within this enforcement discretion category.
| Regulation | Status |
|---|---|
| NDPA 2023 (data protection) | Compliant — see Privacy Policy |
| FCCPA 2018 (consumer protection) | Compliant — transparent pricing, honest representations, complaint handling |
| NAFDAC Act (medical devices) | Not currently registrable as a medical device; monitoring for future digital health guidance |
| Physiotherapy Council of Nigeria Act | Not a clinical practice; content is educational rehabilitation material designed by a licensed physiotherapist |
| CBN payment regulations | Compliant through Paystack (licensed payment service provider) |
Fesera's programme was designed on the principle of clinical safety first. Multiple safety gates are built into the assessment and programme architecture:
These safeguards are screening and risk-reduction tools — not clinical evaluation. Fesera acknowledges:
The programme is not appropriate for individuals with any of the following conditions:
The Fesera programme was designed by a licensed physiotherapist with training in musculoskeletal rehabilitation and chronic pain management. The assessment framework and exercise protocols are grounded in the following validated clinical tools and published evidence:
| Tool / Framework | Source | Application in Fesera |
|---|---|---|
| STarT Back Screening Tool | Keele University (Hill et al., 2008) | Psychosocial risk stratification |
| McKenzie Method (MDT) | McKenzie Institute International | Directional preference classification |
| McGill Method | Prof. Stuart McGill, University of Waterloo | Core endurance and spine-sparing movement principles |
| Cochrane Review (2021) | Hayden et al. — Exercise therapy for CLBP | Evidence base for self-managed exercise |
| ICD-10 M54.5 | WHO International Classification of Diseases | Condition scope definition |
The use of clinician-designed content does not make Fesera a clinical service. The programme provides a population-level protocol refined through user pain profiling — it is not an individualised assessment by a practitioner who has examined you. Users with complex or ambiguous presentations are advised to seek individual professional assessment.
Fesera commits to reviewing the clinical basis of the programme at minimum annually and updating content where significant new evidence emerges. Material clinical updates will be communicated to active users.
All content on the Fesera platform — including assessments, classifications, exercise protocols, education modules, pain response guidance, and any other material — is provided for general information and self-guided rehabilitation purposes only. It does not constitute medical advice, clinical diagnosis, or treatment recommendation.
Before beginning the Fesera programme, and at any point during the programme when you have concerns, consult a qualified healthcare professional, particularly if:
Fesera is not an emergency service. If you are experiencing a medical emergency, call your local emergency number immediately. Do not seek guidance from the Fesera platform in an emergency.
Fesera provides evidence-based content but cannot guarantee any specific clinical outcome. Results vary based on individual factors including pain chronicity, adherence, comorbidities, psychosocial factors, lifestyle, and many others. Statements about research outcomes reflect population-level findings from published literature, not guarantees for individual users.
A full description of how Fesera handles personal and health data — including legal bases, user rights, data retention, and security — is set out in our Privacy Policy.
Key commitments:
Fesera operates in compliance with the Federal Competition and Consumer Protection Act (FCCPA) 2018 and equivalent consumer protection standards in markets where it operates:
All payment processing through Paystack is conducted in compliance with Nigerian financial regulations and Central Bank of Nigeria (CBN) guidelines applicable to digital payment transactions.
Fesera's classification and pain-response systems are rule-based algorithms, not artificial intelligence or machine learning. No user data is fed into a proprietary AI model for diagnostic purposes. All programme decisions — classification, progression, session modification — are based on deterministic clinical logic reviewed and approved by a licensed physiotherapist.
Fesera references published clinical evidence to support its programme claims. References to specific studies are available in the education section of the app. Fesera does not manufacture or fabricate outcome statistics.
Clinical content is versioned. Users on an active programme will not have their ongoing sessions disrupted by content updates. New content versions are published only to new programme starts, or where a user explicitly accepts an update.
Fesera's programme incorporates references to validated clinical tools developed by third parties. The STarT Back Screening Tool is used in accordance with its publicly available validation literature. McKenzie Method and McGill Method principles are referenced based on published academic literature; Fesera is not formally affiliated with or accredited by the McKenzie Institute or any McGill-affiliated body.
All proprietary content — including the assessment logic, programme architecture, exercise protocols, education scripts, and interface design — is owned by Fesera Health Technologies and protected under applicable intellectual property law.
| Matter | Contact |
|---|---|
| Legal notices & compliance enquiries | legal@fesera.com |
| Data protection & privacy requests | privacy@fesera.com |
| Clinical safety concerns & general support | support@fesera.com |
This Legal and Compliance Framework was prepared with reference to: Nigerian law including the NDPA 2023, NDPR 2019, FCCPA 2018, and the Medical and Dental Practitioners Act; international digital health and SaMD frameworks including the IMDRF SaMD framework, EU MDR 2017/745, MDCG 2019-11, MHRA SaMD guidance, and FDA Mobile Medical Application guidance; and international data protection standards including GDPR, UK GDPR, and CCPA/CPRA.
| Version | Date | Change Summary |
|---|---|---|
| 1.0 | 1 June 2026 | Initial publication |