Nalu Neurostimulation System

Stimulator, Spinal-cord, Implanted (pain Relief)

Nalu Medical, Inc.

The following data is part of a premarket notification filed by Nalu Medical, Inc. with the FDA for Nalu Neurostimulation System.

Pre-market Notification Details

Device IDK221376
510k NumberK221376
Device Name:Nalu Neurostimulation System
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad,  CA  92008
ContactChelsea Gutierrez
CorrespondentChelsea Gutierrez
Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad,  CA  92008
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-12
Decision Date2022-06-10

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