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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 K221251
Device Name Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Applicant
Guangzhou Huakai Electronic Technology Co., Ltd.
4th Floor, Bldg. 8, #39 Bi Gang Rd., Dongqu St.,
Huangpu District
Guangzhou,  CN 510730
Applicant Contact Cao Ke
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX  
Date Received05/02/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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