510(k) K200262
K200262 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "L100 Go System". The FDA issued a decision of Substantially Equivalent on Mar 4, 2020. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Bioness, Inc. has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 4, 2020
- Date Received
- Feb 3, 2020
- Clearance Type
- Special
- 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)