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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 K950617
Device Name SMART WAVE GS100
Applicant
Shotwell & Carr, Inc.
3003 Lbj Fwy.
Suite 100
Dallas,  TX  75234
Applicant Contact STAN E TILLMAN
Correspondent
Shotwell & Carr, Inc.
3003 Lbj Fwy.
Suite 100
Dallas,  TX  75234
Correspondent Contact STAN E TILLMAN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/10/1995
Decision Date 10/13/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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