ITO — Twister, Brace Setting Class I
FDA product code ITO covers "Twister, Brace Setting", a Class I medical device regulated under 21 CFR 890.3410. 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
- ITO
- Device Class
- Class I
- Regulation Number
- 890.3410
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K800716 | ipos luneburg | ORTHOTIC LEG GAIT CORRECTOR DEVICE | May 2, 1980 |