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Walker, Mechanical, Poly Vinyl Chloride (Pvc)

FDA product code NXE · 1 cleared devices

Class 1 Physical Medicine
Regulation
21 CFR 890.3825
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
Yes
Clearance span
2005-12-05 – 2005-12-05

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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