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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 K253076
Device Name Cryopush Cold Compression Device (A02-P-001)
Applicant
Chengdu Cryo-Push Medical Technology Co.,Ltd
2, Zone 9 And 102, 105, Zone 20, Huayin Industrial Port
#618, Kexing Rd. (West), Wenjiang District
Chengdu,  CN 611137
Applicant Contact Lifang Yan
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Aria Yao
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
IME  
Date Received09/23/2025
Decision Date 04/02/2026
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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