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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K261131
Device Name 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
2104, Unit4, Bldg.2, Zhongxin Longsheng Sq., # 219 Shenshan
Shenzhen,  CN 518000
Applicant Contact Yang Li
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/06/2026
Decision Date 09/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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