510(k) K200088
K200088 is an FDA 510(k) premarket notification submitted by G.Tec Medical Engineering GmbH for the device "g.Estim FES". The FDA issued a decision of Substantially Equivalent on October 29, 2020. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. G.Tec Medical Engineering GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2020
- Date Received
- January 15, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type