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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K214015
Device Name Palm NRG cellulite body device (model: Palm NRG body 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 510000
Correspondent Contact Cassie Lee
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received12/22/2021
Decision Date 09/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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