510(k) K053192
K053192 is an FDA 510(k) premarket notification submitted by Mjm International Corporation for the device "MODEL 418 SERIES WALKERS". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code NXE (Walker, Mechanical, Poly Vinyl Chloride (Pvc)), a Class I device regulated under 21 CFR 890.3825.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2005
- Date Received
- November 15, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Walker, Mechanical, Poly Vinyl Chloride (Pvc)
- Device Class
- Class I
- Regulation Number
- 890.3825
- Review Panel
- PM
- Submission Type
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.