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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K240011
Device Name Lymphedema Compression
Applicant
Jkh Health Co., Ltd.
4-5f, Bldg. 12, Hengmingzhu Industrial Park
Xinqiao Tongfuyu Industrial Area, Shajing, Baoan
Shenzhen,  CN 518104
Applicant Contact Pu Jiang
Correspondent
Jkh USA, LLC
20 Fairbanks
Suite 171
Irvine,  CA  92618
Correspondent Contact Bill Quanqin Dai
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/02/2024
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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