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.

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: 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

Download summary PDF View on FDA.gov ↗

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