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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K191938
Device Name FitRelief TENS&EMS Wireless Device
Applicant
Heat IN A Click, LLC
1975 Tigertail Blvd.
Dania,  FL  33004
Applicant Contact Guy Levi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510006
Correspondent Contact Cassie Lee
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received07/19/2019
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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