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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 K240986
Device Name Cold Compression
Applicant
JKH Health Co., Ltd.
4-5F, Building 12, Hengmingzhu Industrial Park
Xinqiao Tongfuyu Industrial Area, Shajing, Baoan
Shenzhen,  CN 518104
Applicant Contact Pu Jiang
Correspondent
Jkh USA Llc
14271 Jeffrey Road
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received04/10/2024
Decision Date 05/01/2024
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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