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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K971046
Device Name HANDIFLEX
Applicant
Handiflex Corp.
4611 S. University Dr.
Suite 432
Davie,  FL  33328
Applicant Contact JOSE BRUNO ROMAN
Correspondent
Handiflex Corp.
4611 S. University Dr.
Suite 432
Davie,  FL  33328
Correspondent Contact JOSE BRUNO ROMAN
Regulation Number890.5880
Classification Product Code
JFB  
Date Received03/21/1997
Decision Date 09/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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