Neuraxis, Inc.

Address:829 S Adams St,Versailles,IN,47042,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) (QHH) (1) Percutaneous Nerve Stimulator For Opioid Withdrawal (PZR) (1) Stimulator, Electro-Acupuncture (BWK) (1)

Premarket Exempt

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NSS-2 Bridge - B960NSS200 Catalog Number : 01-1017-NSS-2/BRIDGE

Device Description : The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that ca The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptomsof opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified bytransillumination. NSS-2 BRIDGE stimulator is a battery-operated micro-stimulation appliance weighing approximately 5 gramsdesigned as a disposable product for a single use. The NSS-2 BRIDGE stimulator is placed behind the patient’s ear andconnected to stimulation needles on the auricle. NSS-2 BRIDGE stimulator offers regular therapy over several days. Theappliance transmits low-frequency electric pulses to exposed nerve endings.

Device Class :

Duns Number: 063076701

Premarket Exempt : No

Product Code : PZR

Prescription Use : Yes

Device Count : 1

NSS NeuroStim - B960NSS201 Catalog Number : 01-1021

Device Description : The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.

Device Class :

Duns Number: 063076701

Premarket Exempt : No

Product Code : BWK

Prescription Use : Yes

Device Count : 1

NSS IB-STIM - B960NSS203 Catalog Number : 01-1020

Device Description : The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PEN The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.

Device Class :

Duns Number: 063076701

Premarket Exempt : No

Product Code : QHH

Prescription Use : Yes

Device Count : 1

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