510(k) clearance

Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

FDA 510(k) source

510(k) number

K261131

Applicant

Shenzhen Osto Medical Technology Co.,Ltd

Decision date

Sep 6, 2026

Date received

Apr 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NUH

Device type

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device class

Class II

Regulation

21 CFR 882.5890

Advisory committee

Neurology

Statement or summary

Statement

Third party

N

Location

Shenzhen, CN