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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Measuring
510(k) Number K990813
Device Name REHCOR
Applicant
Electromed Corp.
Po 7007
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Electromed Corp.
Po 7007
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/11/1999
Decision Date 04/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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