FX-2P NMS (2 CHANNEL PORTABLE)

Stimulator, Muscle, Powered

FX-2

The following data is part of a premarket notification filed by Fx-2 with the FDA for Fx-2p Nms (2 Channel Portable).

Pre-market Notification Details

Device IDK945508
510k NumberK945508
Device Name:FX-2P NMS (2 CHANNEL PORTABLE)
ClassificationStimulator, Muscle, Powered
Applicant FX-2 616 VINEYARD PT. Guilford,  CT  06437
ContactMark Heller
CorrespondentMark Heller
FX-2 616 VINEYARD PT. Guilford,  CT  06437
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-09
Decision Date1995-05-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858703006115 K945508 000
00858703006092 K945508 000

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