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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 K870402
Device Name MOBILIMB HAND EXERCISER
Applicant
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Applicant Contact KEVIN J DUNLEAVY
Correspondent
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Correspondent Contact KEVIN J DUNLEAVY
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/02/1987
Decision Date 03/16/1987
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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