ROMFLEX REHAB EQUIP EXTREMITIES UNIT

Exerciser, Powered

DYNA FLEX, INTL.

The following data is part of a premarket notification filed by Dyna Flex, Intl. with the FDA for Romflex Rehab Equip Extremities Unit.

Pre-market Notification Details

Device IDK910150
510k NumberK910150
Device Name:ROMFLEX REHAB EQUIP EXTREMITIES UNIT
ClassificationExerciser, Powered
Applicant DYNA FLEX, INTL. 151 EAST BROAD ST. Clinton,  TN  37716
ContactHarrison Beal
CorrespondentHarrison Beal
DYNA FLEX, INTL. 151 EAST BROAD ST. Clinton,  TN  37716
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-14
Decision Date1991-01-23

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