Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more— 510(k) K261131

Name: FDA 510(k) clearance K261131
Creator: U.S. Food and Drug Administration
Published: 2026-09-06

Substantially Equivalent

Shenzhen Osto Medical Technology Co.,Ltd

FDA 510(k) clearance K261131 for Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more, Substantially Equivalent on 2026-09-06. Applicant: Shenzhen Osto Medical Technology Co.,Ltd. Device class: 2.

Summary

Shenzhen Osto Medical Technology's Electrical Muscle Stimulator is cleared in 21 models, all with AST- model numbers (AST-105DJ through AST-500E). It's filed under NUH, over-the-counter transcutaneous nerve stimulators. The device name says muscle stimulator while the code name says nerve stimulator, and the record doesn't explain the fit.

Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel. It was a Traditional 510(k).

Shenzhen Osto filed from Shenzhen, China. Review took 153 calendar days (April 6 to September 6, 2026).

Clearance details

Device name as filed: 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.)
Applicant: Shenzhen Osto Medical Technology Co.,Ltd
Product code: Product code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2026-04-06
Decision date: 2026-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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