ANKLE CALF EXERCISER PHLEBOPUMP

Exerciser, Powered

PREVENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Prevent Products, Inc. with the FDA for Ankle Calf Exerciser Phlebopump.

Pre-market Notification Details

Device IDK952975
510k NumberK952975
Device Name:ANKLE CALF EXERCISER PHLEBOPUMP
ClassificationExerciser, Powered
Applicant PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul,  MN  55118
ContactCarol Garcia
CorrespondentCarol Garcia
PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul,  MN  55118
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-27
Decision Date1996-09-25
Summary:summary

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