Massage pad v2: one version change, three evidence tasks
Real sources · Illustrative request · Sample version
Customer question
Fictional v2 changes pressure distribution and preset modes and proposes a short-term-comfort claim.
Does the v1 experience study still apply, and which changes need output or usability checks first?
Separate output consistency, user experience and disease outcomes. Short-term comfort does not establish long-term pain treatment.
v1 → v2 change-to-evidence matrix
| Check / stage | Chart content |
|---|---|
| Pressure distribution | Assumed changed; old output materials do not automatically cover it |
| Preset modes | Assumed changed; verify use and software version |
| Comfort experience | Measure this version with defined time points and comparison |
| Pain treatment | Not inferred from short-term experience |
FDA 2026 guidance informs discussion of general wellness versus disease-related use; it is not a risk classification or authorisation for this pad.
Analysis excerpt
| Check | Finding / sample content | Use |
|---|---|---|
| Reusable material | v1 identity and study methods inform review; effects need separate assessment | Record change impact and reuse rationale item by item |
| Evidence sequence | Check technical output before choosing experience comparisons | List bench, usability and experience-study tasks separately |
Delivery manifest
| File | Format | Contents |
|---|---|---|
| v1-v2-difference-map.xlsx | XLSX | Differences in materials, contact site, output, modes, software and intended use. |
| claim-reuse-review.pdf | Reuse assessment and rationale per prior source, with claim impact and gaps. | |
| test-study-framework.docx | DOCX | Staged planning inputs for bench, usability and human-experience studies. |
This is an illustrative formal delivery manifest. This pack supplies an HTML report, CSV tables and a source register. Agree formal formats, quantities and scope in the quote.
Acceptance criteria
- Model, hardware/software version, outputs, use dose and users are identified.
- Engineering, safety, experience and health outcomes are separated; transfer from other versions/products has reasons and limits.
- Each key gap links to a concrete measurement/testing requirement, relevant specialist role and implementation conditions.
Sources
- FDA 2026: General Wellness — policy for low risk devices
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices - MDCG 2020-5: Clinical evaluation — equivalence
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf