510(k) K202648
K202648 is an FDA 510(k) premarket notification submitted by Shenzhen Konmed Technology Co., Ltd. for the device "Biofeedback Nerve and Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on December 8, 2020. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Shenzhen Konmed Technology Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2020
- Date Received
- September 11, 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