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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 K926265
Device Name NEURO-CARE 1000
Applicant
Ems Northwest
913 SE 121st Ave.
P.O. Box 84331
Vancouver,  WA  98684
Applicant Contact THOMAS G OLIVER
Correspondent
Ems Northwest
913 SE 121st Ave.
P.O. Box 84331
Vancouver,  WA  98684
Correspondent Contact THOMAS G OLIVER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/18/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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