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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, ultrasound and muscle, for use in applying therapeutic deep heat
510(k) Number K902860
Device Name INTELECT 170
Original Applicant
4717 adams rd.
p.o. box 4287
hixson,  TN  37343
Original Contact grahame r watts
Regulation Number890.5860
Classification Product Code
Date Received06/29/1990
Decision Date 09/27/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No