510(k) K132416
K132416 is an FDA 510(k) premarket notification submitted by Hasomed GmbH for the device "REHASTIM 2, ERIGOPRO (FES)". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Hasomed GmbH has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2014
- Date Received
- Aug 2, 2013
- 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)