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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 K212935
Device Name Air Pressure Foot Massager
Applicant
Xiamen Simo Electronic Co., Ltd.
Floor 3rd-5th, # 173 Siming Park,
Tong'An Industrial Zone, Tong'An District
Xia Men,  CN 361100
Applicant Contact Wang Qinsheng
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/15/2021
Decision Date 02/19/2022
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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