Axon Therapy

Stimulator, Nerve, Transcutaneous, For Pain Relief

NeuraLace Medical, Inc.

The following data is part of a premarket notification filed by Neuralace Medical, Inc. with the FDA for Axon Therapy.

Pre-market Notification Details

Device IDK210021
510k NumberK210021
Device Name:Axon Therapy
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant NeuraLace Medical, Inc. 3770 Tansy St #101 San Diego,  CA  92121
ContactJoe Milkovits
CorrespondentAllison C. Komiyama
AcKnowledge Regulatory Strategies LLC 2251 San Diego Ave, Suite B-257 San Diego,  CA  92121
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-06-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08592566001055 K210021 000
08592566478314 K210021 000
08592566476556 K210021 000
08592566471506 K210021 000
08592566410567 K210021 000

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