Autopilot update
What it takes to sell this legally
Vibgen drafts the likely classification and safe positioning. A regulatory consultant confirms before launch.
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This is research and workflow support, not legal advice. A qualified regulatory consultant confirms the final classification and claims.
What this device is, in plain terms
Temporary localized vibration massage over a small body area for general wellness and comfort, using a disposable adhesive pad as the attachment interface. Not intended to diagnose, treat, cure, or prevent any disease.
How it's likely classified
- Device type
- Powered vibratory massage accessory positioned for general wellness; likely outside the scope of higher-risk therapeutic device codes if claims remain wellness-only.
- Risk estimate
- Likely low-risk if positioned as a wellness comfort accessory; classification must be confirmed by a regulatory consultant.
- 510(k) exemption
- Many low-risk powered massagers are 510(k)-exempt under their product code, subject to limitations. Exemption status and limitations require confirmation against the final intended use and claims.
FDA product code candidates
Candidates to confirm — not a determination.
| Code | Description | Note |
|---|---|---|
| ISA | Therapeutic massager (powered), candidate | Requires claims confirmation |
| NUH | Powered muscle stimulator (NOT a target — avoid TENS framing) | Excluded if no stimulation claims |
| — | General wellness (non-device) positioning | If strictly wellness claims |
Safe to say
- Localized vibration massage accessory
- Temporary local comfort
- Relaxation and wellness use
Avoid claiming
- Treats pain
- Treats neuropathy
- Treats muscle disease
- Medical therapy for diagnosed conditions
- Equivalent to TENS
- Improves circulation (unless substantiated)
Testing needed
- Biocompatibility (ISO 10993) for adhesive skin-contact pad
- Electrical safety / battery safety (applicable IEC standards)
- Vibration intensity characterization and limits
- Usability / human factors for unsupervised consumer use
- Labeling and instructions-for-use review
Labeling cautions
- Clearly state wellness / comfort use only
- Include contraindications and stop-use guidance
- Avoid implying medical treatment of conditions
- Specify session duration and placement limits
Before launch
CheckpointA regulatory consultant must approve before launch.