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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K901796
Device Name PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE
Applicant
Component Equipment Mfg., Inc.
615 Conrad St.
Colorado Springs,  CO  80915
Applicant Contact TIMOTHY J JUNK
Correspondent
Component Equipment Mfg., Inc.
615 Conrad St.
Colorado Springs,  CO  80915
Correspondent Contact TIMOTHY J JUNK
Regulation Number890.5660
Classification Product Code
ISA  
Date Received04/19/1990
Decision Date 06/06/1990
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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