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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 K850030
Device Name CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE
Applicant
Arc Motion , Ltd.
2n451 Mildred St.
Glen Ellyn,  IL  60137
Applicant Contact VILIS BERZE
Correspondent
Arc Motion , Ltd.
2n451 Mildred St.
Glen Ellyn,  IL  60137
Correspondent Contact VILIS BERZE
Regulation Number890.5380
Classification Product Code
BXB  
Date Received01/04/1985
Decision Date 04/25/1985
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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