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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)
Guangzhou Hua Kai Electronic Technology Co., Ltd.
4th Floor, Building 8, No.39 Bi Gang Road,
Dongqu Street, Huangpu District
Guangzhou,  CN 510730
Applicant Contact Cao Ke
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road,
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
Subsequent Product Codes
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