510(k) K073521
K073521 is an FDA 510(k) premarket notification submitted by Musmate, Ltd. for the device "MUSMATE WALKING AID". The FDA issued a decision of Substantially Equivalent on February 4, 2008. The device falls under product code OHI (Orthosis, Foot Drop), a Class I device regulated under 21 CFR 890.3475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2008
- Date Received
- December 14, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Foot Drop
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.