COMPUTERIZED TESTING AND EXERCISE SYSTEMS

Exerciser, Powered

HENLEY INTL.

The following data is part of a premarket notification filed by Henley Intl. with the FDA for Computerized Testing And Exercise Systems.

Pre-market Notification Details

Device IDK926313
510k NumberK926313
Device Name:COMPUTERIZED TESTING AND EXERCISE SYSTEMS
ClassificationExerciser, Powered
Applicant HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
ContactErnest J Henley
CorrespondentErnest J Henley
HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-15
Decision Date1994-02-04

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