510(k) K220002
K220002 is an FDA 510(k) premarket notification submitted by Zhejiang Qiangnao Technology Co.,Ltd for the device "Dexus Prosthetics System (Model: MSL1, MSR1)". The FDA issued a decision of Substantially Equivalent on September 9, 2022. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Zhejiang Qiangnao Technology Co.,Ltd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2022
- Date Received
- January 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type