MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO

System, Isokinetic Testing And Evaluation

UNIVERSAL GYM EQUIPMENT, INC.

The following data is part of a premarket notification filed by Universal Gym Equipment, Inc. with the FDA for Musculoskeletal Evaluation Rehabilitation/conditio.

Pre-market Notification Details

Device IDK873659
510k NumberK873659
Device Name:MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO
ClassificationSystem, Isokinetic Testing And Evaluation
Applicant UNIVERSAL GYM EQUIPMENT, INC. C/O DARBY & DARBY 405 LEXINGTON AVENUE New York,  NY  10174
ContactGordon D Coplein
CorrespondentGordon D Coplein
UNIVERSAL GYM EQUIPMENT, INC. C/O DARBY & DARBY 405 LEXINGTON AVENUE New York,  NY  10174
Product CodeIKK  
CFR Regulation Number890.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-10
Decision Date1988-04-21

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