FLEXXR* CPM SYSTEM

Exerciser, Powered

QAREX LABORATORIES, INC.

The following data is part of a premarket notification filed by Qarex Laboratories, Inc. with the FDA for Flexxr* Cpm System.

Pre-market Notification Details

Device IDK834203
510k NumberK834203
Device Name:FLEXXR* CPM SYSTEM
ClassificationExerciser, Powered
Applicant QAREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-05
Decision Date1984-01-30

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