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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K200561
Device Name StimPlus Patch, StimPlus Patch, StimPlus Patch
Applicant
Jkh Health Co., Ltd.
4-5f, Bldg. 12, Hengmingzhu Ind. Park, Tongfuyu Ind.
Area, Shajing, Baoan
Shenzhen,  CN 518104
Applicant Contact Pu Jiang
Correspondent
Jkh Health Co., Ltd.
4-5f, Bldg. 12, Hengmingzhu Ind. Park, Tongfuyu Ind.
Area, Shajing, Baoan
Shenzhen,  CN 518104
Correspondent Contact Pu Jiang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX   NYN  
Date Received03/04/2020
Decision Date 07/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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