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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K213745
Device Name Air Compression Therapy Device, model: ST-502
Applicant
Shenzhen Future Electronic Co., Ltd.
Bldg. B. Qiangchengda Industrial Park, # 30, Youtian Rd.,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Zhao Qihong
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave.
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/29/2021
Decision Date 03/31/2022
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
Predetermined Change
Control Plan Authorized		 No
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