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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 K930780
Device Name ADV400 TOE CPM
Applicant
Advanced Kinetics, Inc.
111 Silver Hill Rd.
Concord,  MA  01742
Applicant Contact ERNEST CARABILLO
Correspondent
Advanced Kinetics, Inc.
111 Silver Hill Rd.
Concord,  MA  01742
Correspondent Contact ERNEST CARABILLO
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/16/1993
Decision Date 02/17/1994
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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