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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Elastic
510(k) Number K040054
Device Name BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
Applicant
Theodore Barash
16879 C Isle Of Palms Dr.
Delray Beach,  FL  33484
Applicant Contact THEODORE BARASH
Correspondent
Theodore Barash
16879 C Isle Of Palms Dr.
Delray Beach,  FL  33484
Correspondent Contact THEODORE BARASH
Regulation Number880.5075
Classification Product Code
FQM  
Date Received01/12/2004
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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