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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 K971542
Device Name ORTHO DX NEUROMUSCULAR STIMULATOR
Applicant
Rehabilicare, Inc.
1811 Old Hwy. 8
New Brighton,  MN  55112
Applicant Contact GARY L MOORE
Correspondent
Rehabilicare, Inc.
1811 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact GARY L MOORE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/28/1997
Decision Date 08/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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