NF-1 MINDPEACE

Cranial Electrotherapy Stimulator To Treat Depression

NEUROFITNESS

The following data is part of a premarket notification filed by Neurofitness with the FDA for Nf-1 Mindpeace.

Pre-market Notification Details

Device IDK895175
510k NumberK895175
Device Name:NF-1 MINDPEACE
ClassificationCranial Electrotherapy Stimulator To Treat Depression
Applicant NEUROFITNESS 14770 N.E. 95TH ST. Redmond,  WA  98052
ContactCarl Christine
CorrespondentCarl Christine
NEUROFITNESS 14770 N.E. 95TH ST. Redmond,  WA  98052
Product CodeJXK  
CFR Regulation Number882.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-10
Decision Date1989-11-08

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