OTX — Foot Wrap For Treating Restless Leg Syndrome Symptoms Class I
FDA product code OTX covers "Foot Wrap For Treating Restless Leg Syndrome Symptoms", a Class I medical device regulated under 21 CFR 890.5760. 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
- OTX
- Device Class
- Class I
- Regulation Number
- 890.5760
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN110009 | mary m. sorg (an individual) dba pj sleeper | RESTLESS LEG DEVICE | December 18, 2013 |