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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 K251623
Device Name Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
Applicant
Shenzhen Yicai Health Technology Co., Ltd.
11th Floor, Zhenqian Bldg., Yousong Community
Longhua St., Longhua District
Shenzhen,  CN 518110
Applicant Contact Jie Xie
Correspondent
Shenzhen Yicai Health Technology Co., Ltd.
11th Floor, Zhenqian Bldg., Yousong Community
Longhua St., Longhua District
Shenzhen,  CN 518110
Correspondent Contact Jie Xie
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/28/2025
Decision Date 09/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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