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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 K910149
Device Name ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
Applicant
Dyna Flex, Intl.
151 E. Broad St.
Clinton,  TN  37716
Applicant Contact HARRISON BEAL
Correspondent
Dyna Flex, Intl.
151 E. Broad St.
Clinton,  TN  37716
Correspondent Contact HARRISON BEAL
Regulation Number890.5380
Classification Product Code
BXB  
Date Received01/14/1991
Decision Date 01/18/1991
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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