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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 K252386
Device Name Hot and Cold Compression System (A02-C-032)
Applicant
Chengdu Cryo-Push Medical Technology Co.,Ltd
102, 105, Zone 20, Huayin Industrial Port, #618, Kexing
Rd.(West), Wenjiang District
611137,  CN Chengdu
Applicant Contact Peiyong Zhang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518100
Correspondent Contact Lucy Yan
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received07/31/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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