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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 K881024
Device Name ARCHGAUGE(TM)
Applicant
Archxerciser Corp.
790 Prigge Rd.
St. Louis,  MO  63138
Applicant Contact SUZANNE MARTINEZ
Correspondent
Archxerciser Corp.
790 Prigge Rd.
St. Louis,  MO  63138
Correspondent Contact SUZANNE MARTINEZ
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/10/1988
Decision Date 04/08/1988
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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