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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 K844118
Device Name THERAPEUTIC LIMB MANIPULATOR
Applicant
Donald E. Redding
P.O. Box 831
Port Oxford,  OR  97465
Correspondent
Donald E. Redding
P.O. Box 831
Port Oxford,  OR  97465
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/23/1984
Decision Date 05/17/1985
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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