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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K211942
Device Name Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
Applicant
Shenzhen OSTO Technology Company Limited
No.43 Longfeng Road, Xinsheng Community, Longgang Street,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Li Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Cassie Lee
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
IRT   NUH  
Date Received06/23/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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