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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 K073237
Device Name REHASTIM & REHAMOVE
Applicant
HASOMED GMBH
PAUL-ECKE-STRASSE 1
MAGDEBURG,  DE 39114
Applicant Contact MATTHIAS WEBER
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number882.5810
Classification Product Code
GZI  
Date Received11/16/2007
Decision Date 12/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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