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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 K253150
Device Name Cryon-X Cold Compression
Applicant
Jkh Health Co., Ltd.
15f, Bldg. 2, Zone 1, Xinqiaodong Advanced Manufacturing
Hongtian Rd., Huangpu Community, Xinqiao St., Baoan Dist
Shenzhen,  CN 518125
Applicant Contact Jiang Pu
Correspondent
Jkh USA, LLC
14271 Jeffrey Rd.
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Codes
ILO   JOW  
Date Received09/25/2025
Decision Date 10/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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