510(k) K262654
K262654 is an FDA 510(k) premarket notification submitted by Zhejiang Qiangnao Technology Co.,Ltd for the device "Dexus Prosthetic System (MSL2, MSR2)". The FDA issued a decision of Substantially Equivalent on August 27, 2026. 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
- August 27, 2026
- Date Received
- July 30, 2026
- Clearance Type
- Special
- 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