510(k) K141812
K141812 is an FDA 510(k) premarket notification submitted by Otto Bock Healthcare Products GmbH for the device "MYGAIT STIMULATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 2, 2015. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Otto Bock Healthcare Products GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2015
- Date Received
- July 7, 2014
- 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