MAXISTIM

Stimulator, Nerve, Peripheral, Electric

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Maxistim.

Pre-market Notification Details

Device IDK955031
510k NumberK955031
Device Name:MAXISTIM
ClassificationStimulator, Nerve, Peripheral, Electric
Applicant LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
ContactAlfred C Coats
CorrespondentAlfred C Coats
LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
Product CodeKOI  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-02
Decision Date1996-12-10

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