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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 K150308
Device Name Palm TENS
Applicant
Heat IN A Click, LLC
1924 Tigertail Blvd.
Dania,  FL  33304
Applicant Contact GUY LEVI
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact KEVIN WALLS
Regulation Number882.5890
Classification Product Code
NUH  
Date Received02/09/2015
Decision Date 10/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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