510(k) clearance

Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)

FDA 510(k) source

510(k) number

K262470

Applicant

Changsha Anxiang Medical Technology Co., Ltd.

Decision date

Oct 30, 2026

Date received

Jul 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NGX

Device type

Stimulator, Muscle, Powered, For Muscle Conditioning

Device class

Class II

Regulation

21 CFR 890.5850

Advisory committee

Physical Medicine

Statement or summary

Statement

Third party

N

Location

Changsha, CN