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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K240788
Device Name Ultrasound Stimulator
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
14271 Jeffrey Rd.
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number890.5300
Classification Product Code
IMI  
Subsequent Product Code
PFW  
Date Received03/22/2024
Decision Date 06/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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