Dexus Prosthetic System (MSL2, MSR2)— 510(k) K262654
Substantially EquivalentZhejiang Qiangnao Technology Co.,Ltd
FDA 510(k) clearance K262654 for Dexus Prosthetic System (MSL2, MSR2), Substantially Equivalent on 2026-08-27. Applicant: Zhejiang Qiangnao Technology Co.,Ltd. Device class: 2.
Summary
Zhejiang Qiangnao Technology's Dexus Prosthetic System lists models MSL2 and MSR2. It's filed under product code GXY, cutaneous electrodes, and the record doesn't describe the system beyond that.
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel. It came in as a Special 510(k).
The applicant filed from Hangzhou, China. The substantially equivalent decision came 28 calendar days after receipt (July 30 to August 27, 2026).
Clearance details
- Applicant
- Zhejiang Qiangnao Technology Co.,Ltd
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hangzhou, CN
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More clearances from Zhejiang Qiangnao Technology Co.,Ltd
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