Walker, Mechanical, Poly Vinyl Chloride (Pvc)
The Walker, Mechanical, Poly Vinyl Chloride (PVC) (product code NXE) is a four-legged mobility aid with a PVC frame intended to provide moderate weight support while walking for disabled persons who lack sufficient strength, balance, or endurance. It is classified as FDA Class 1, GMP-exempt, and exempt from 510(k) requirements, regulated under 21 CFR 890.3825 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NXE
- Device Class
- FDA class 1
- Regulation Number
- 890.3825
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K053192 | MODEL 418 SERIES WALKERS | Dec 05, 2005 | Substantially Equivalent | Mjm International Corporation |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.