FDA product code NXE: Walker, Mechanical, Poly Vinyl Chloride (Pvc)
NXE is the FDA product code for walker, mechanical, poly vinyl chloride (pvc). It is a Class I device, regulated under 21 CFR 890.3825 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under NXE. The average 510(k) review took 20 days (median 20).
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.
Classification
| Field | Value |
|---|---|
| Device name | Walker, Mechanical, Poly Vinyl Chloride (Pvc) |
| Device class | Class I |
| Regulation | 21 CFR 890.3825 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every NXE clearance
Top NXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mjm International Corporation | 1 | 2005-12-05 |
Most recent NXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053192 | Mjm International Corporation | MODEL 418 SERIES WALKERS | 2005-12-05 | 20 |
Recalls for NXE devices
openFDA lists no recalls for product code NXE.
Frequently asked questions
What is FDA product code NXE?
NXE is the FDA product code for walker, mechanical, poly vinyl chloride (pvc). It is a Class I device, regulated under 21 CFR 890.3825 and reviewed by the Physical Medicine panel.
What device class is NXE?
Class I, regulation 21 CFR 890.3825. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXE?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most NXE clearances?
Mjm International Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NXE
- Run a recall and safety report across every NXE manufacturer
- Watch product code NXE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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