510(k) K153163
K153163 is an FDA 510(k) premarket notification submitted by Rehabtronics, Inc. for the device "ReGrasp". The FDA issued a decision of Substantially Equivalent on Apr 7, 2016. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Rehabtronics, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 7, 2016
- Date Received
- Nov 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Neuromuscular, External Functional
- Device Class
- Class II
- Regulation Number
- 882.5810
- Review Panel
- NE
- Submission Type
- 510(k)