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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 K162470
Device Name RT300 FES cycle ergometer
Applicant
Restorative Therapies, Inc.
1434 Fleet St.
Baltimore,  MD  21231
Applicant Contact Andrew Barriskill
Correspondent
Restorative Therapies, Inc.
1434 Fleet St.
Baltimore,  MD  21231
Correspondent Contact Andrew Barriskill
Regulation Number882.5810
Classification Product Code
GZI  
Date Received09/06/2016
Decision Date 07/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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