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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K944543
Device Name BIOFLEX GARMENTS, ASSORTED MODELS
Applicant
Bioflex, Inc.
736 Kenwick Rd.
Columbus,  OH  43209
Applicant Contact PHILIP MUCCIO
Correspondent
Bioflex, Inc.
736 Kenwick Rd.
Columbus,  OH  43209
Correspondent Contact PHILIP MUCCIO
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/15/1994
Decision Date 07/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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