ISOSTATION SHOULDER MACHINE

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 Shoulder Machine.

Pre-market Notification Details

Device IDK841849
510k NumberK841849
Device Name:ISOSTATION SHOULDER MACHINE
ClassificationSystem, Isokinetic Testing And Evaluation
Applicant ISOTECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIKK  
CFR Regulation Number890.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-03
Decision Date1984-05-14

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