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Neuraxis, Inc.
NEURAXIS, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009445917 | 3009293069 | NEURAXIS, INC | 1 | N | 2026-01-01 | 11611 N Meridian St Suite 330 Carmel IN US 46032 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B960NSS200 | NSS-2 Bridge - 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. | 812-689-0791 | tcarrico@neuraxis.com |
| B960NSS201 | NSS NeuroStim - 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. | 8126890791 | tom@i-h-s.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 280427 | 1074227881 | K252024 | NeurAxis IB-Stim (01-1020) | QHH | 2025-10-16 |
| 280427 | 1211074572 | K242304 | RED | KLA | 2024-12-06 |
| 280427 | 1155942115 | K140530 | Electro Auricular Device | BWK | 2014-10-02 |
| 280427 | 1829693074 | DEN180057 | IB-Stim | QHH | 2019-06-07 |
Product Codes Associated With Registrations#
PMN#
NeurAxis IB-Stim (01-1020)
Neuraxis
GUDID#
NSS IB-STIM - The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 8 years of age or older with functional abdominal pain associated with irritable bowel syndrome (IBS) and/or functional dyspepsia. 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 4 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
2020-11-09
RED Prep-Kit - "The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of one to five (1-5) cartons and is to be used with the NeurAxis RED (PN 02-2050, UDI: B960RED201) device. Each carton contains the following items: 1) One (1) pack of Extra-Large Heavy Absorbency Disposable Under-pads. Medline, MSC282070LB or similar. Product Code LRO. 2) Two (2) tubes of single use Lubricating Jelly. Medline, MDS032280 or similar. Product Code KMJ. 3) Two (2) packs of 10/hard tray Woven Sterile Gauze Sponges 4""x4"", 12-ply. Medline, NON21426 or similar. Product Code EFQ. 4) One (1) pack of five (5) Ready Bath Select Bathing cloths 8x8 inch. Medline, MSC095109 or similar. Product Code KKX. 5) One (1) Sterile Skin Marker with Ruler. Medline, DYNJSM01 or similar. Product Code FTY. 6) One Instructions For Use [IFU] (LBL6014). Minimum 1 IFU/Box. Note: Box contains 1-5 cartons."
2025-01-09
NSS-2 Bridge - 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.
2021-02-12
RED - The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted into the rectum. RED is used to evaluate the neuromuscular function of the patient's ability to expel its content from the rectum and a qualitative test for rectal hypersensitivity. It is intended to be used in a clinical setting by providers in adult populations. RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume the foam displaces when inflated with room air is 52 - 60 ml. This passive expansion provides the same function as filling an empty balloon with water or air, but the proprietary foam behaves and feels like normal stool. When expanded, the volume of material inside the patient’s rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate at lower volumes. This is measured by asking patients a few questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually. Cartons may have 1-5 devices as needed.
2025-01-09
NSS NeuroStim - 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.
2020-11-09