K261131Substantially Equivalent

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.)

Name: K261131 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.)
Creator: Shenzhen Osto Medical Technology Co.,Ltd
Published: 2026-09-06
License: https://open.fda.gov/license/

Shenzhen Osto Medical Technology Co.,Ltd, Shenzhen, CN / Traditional, Substantially Equivalent

FDA source

Clearance record

Decision date: 2026-09-06
Received: 2026-04-06 (153 days to decision)
Product code: NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation: 21 CFR 882.5890
Device class: Class II
Review panel: Neurology
Applicant: Shenzhen Osto Medical Technology Co.,Ltd 2104, Unit4, Bldg.2, Zhongxin Longsheng Sq., # 219 Shenshan, Shenzhen, CN
510(k) summary: Statement
Third party review: No

Clearances, product code NUH

Trailing 12 months

10 clearances under product code NUH in the twelve months to October 2026, November 2025 the highest month at 3.

Show the numbers

Monthly 510(k) clearances under FDA product code NUH, trailing twelve months
Month	Clearances
November 2025	3
December 2025	3
January 2026	0
February 2026	0
March 2026	1
April 2026	0
May 2026	0
June 2026	2
July 2026	0
August 2026	0
September 2026	1
October 2026	0