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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, For Pain Relief
510(k) Number K191547
Device Name ReliefBand
Applicant
ReliefBand Technologies LLC
220 Gibraltar Rd Ste 270
Horsham,  PA  19044
Applicant Contact Barbara Whitman
Correspondent
ReliefBand Technologies LLC
220 Gibraltar Rd Ste 270
Horsham,  PA  19044
Correspondent Contact Barbara Whitman
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/12/2019
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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