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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 K970847
Device Name IMPULSE HVG
Applicant
Armstrong Industries, Inc.
801 Jupiter Rd., Suite 102
Plano,  TX  75074
Applicant Contact JOHN P LANDINO
Correspondent
Armstrong Industries, Inc.
801 Jupiter Rd., Suite 102
Plano,  TX  75074
Correspondent Contact JOHN P LANDINO
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/07/1997
Decision Date 09/10/1997
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
Predetermined Change
Control Plan Authorized		 No
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