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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K153163
Device Name ReGrasp
Applicant
Rehabtronics, Inc.
#4532, 10230 Jasper Ave.
Edmonton,  CA T5J 4P6
Applicant Contact Mike Pearson
Correspondent
Rehabtronics, Inc.
#4532, 10230 Jasper Ave.
Edmonton,  CA T5J 4P6
Correspondent Contact Mike Pearson
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received11/02/2015
Decision Date 04/07/2016
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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