FDA product code NXE

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

Physical Medicine·Class 1·21 CFR 890.3825
US regulatory classifications
US Product Code (FDA)
NXE
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 890.3825
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
Yes
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Walker, Mechanical, Poly Vinyl Chloride (Pvc) is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.