PMV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orthosis, Limb, For Back Pain
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- FDA definition
- Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| Beactive Brace (K151476) | Natures Pillows, Inc. | 2016-02-26 | + Add |
Track PMV automatically
Every clearance here is in the API, with alerts when new ones post.