ISOSTATION ANKLE/SUBTALAR MACHINE A-100

System, Isokinetic Testing And Evaluation

ISOTECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isostation Ankle/subtalar Machine A-100.

Pre-market Notification Details

Device IDK844060
510k NumberK844060
Device Name:ISOSTATION ANKLE/SUBTALAR MACHINE A-100
ClassificationSystem, Isokinetic Testing And Evaluation
Applicant ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough,  NC  27278
ContactMartin
CorrespondentMartin
ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough,  NC  27278
Product CodeIKK  
CFR Regulation Number890.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-18
Decision Date1984-11-23

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