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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K922493
Device Name AMERICAN MEDICAL MFG. LUMBAR CPM
Applicant
American Medical Corp.
90 Saratoga Dr.
Lawrenceville,  GA  30244
Applicant Contact MICHELLE J ALSUP
Correspondent
American Medical Corp.
90 Saratoga Dr.
Lawrenceville,  GA  30244
Correspondent Contact MICHELLE J ALSUP
Regulation Number890.5380
Classification Product Code
BXB  
Date Received05/27/1992
Decision Date 07/27/1992
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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