NXE · Walker, Mechanical, Poly Vinyl Chloride (Pvc)
Physical Medicine · 21 CFR 890.3825 · Class 1
Overview
| Product Code | NXE |
|---|---|
| Device Name | Walker, Mechanical, Poly Vinyl Chloride (Pvc) |
| Regulation | 21 CFR 890.3825 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A mechanical walker is a four-legged device with a metal 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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053192 | MODEL 418 SERIES WALKERS | Mjm International Corporation | Dec 5, 2005 | SESE |
Top Applicants
- Mjm International Corporation — 1 clearance
