NXE — Walker, Mechanical, Poly Vinyl Chloride (Pvc) Class I
FDA product code NXE covers "Walker, Mechanical, Poly Vinyl Chloride (Pvc)", a Class I medical device regulated under 21 CFR 890.3825. 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
- NXE
- Device Class
- Class I
- Regulation Number
- 890.3825
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053192 | mjm international corporation | MODEL 418 SERIES WALKERS | December 5, 2005 |