NKI — Goniometer With Electrodes Class II
FDA product code NKI covers "Goniometer With Electrodes", a Class II medical device regulated under 21 CFR 888.1500. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NKI
- Device Class
- Class II
- Regulation Number
- 888.1500
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Orthopedic
- Implant
- No
Definition
A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033193 | friendly sensors | SONOSENS | January 23, 2004 |