PMV — Orthosis, Limb, For Back Pain Class I
FDA product code PMV covers "Orthosis, Limb, For Back Pain", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PMV
- Device Class
- Class I
- Regulation Number
- 890.3475
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K151476 | natures pillows | Beactive Brace | February 26, 2016 |