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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K012885
Device Name NEUROMOVE NM900
Applicant
DAN MED, INC.
4 WEST DRY CREEK CIRCLE,
SUITE 260
DENVER,  CO  80120
Applicant Contact THOMAS SANDGAARD
Correspondent
DAN MED, INC.
4 WEST DRY CREEK CIRCLE,
SUITE 260
DENVER,  CO  80120
Correspondent Contact THOMAS SANDGAARD
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
HCC  
Date Received08/28/2001
Decision Date 11/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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