510(k) clearance

Dexus Prosthetic System (MSL2, MSR2)

FDA 510(k) source

510(k) number

K262654

Applicant

Zhejiang Qiangnao Technology Co.,Ltd

Decision date

Aug 27, 2026

Date received

Jul 30, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

GXY

Device type

Electrode, Cutaneous

Device class

Class II

Regulation

21 CFR 882.1320

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

Hangzhou, CN