NSS IB-STIM 01-1020

GUDID B960NSS2031

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.

Innovative Health Solutions, Inc

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Primary Device IDB960NSS2031
NIH Device Record Key7a772919-6c75-4ab6-86ea-7097ba69c0a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNSS IB-STIM
Version Model NumberIB-STIM
Catalog Number01-1020
Company DUNS063076701
Company NameInnovative Health Solutions, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Phone8126890791
Emailtcarrico@neuraxis.com
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Emailtcarrico@neuraxis.com
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Emailtcarrico@neuraxis.com
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Emailtcarrico@neuraxis.com
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Emailtcarrico@neuraxis.com
Phone8126890791
Emailtcarrico@neuraxis.com
Phone8126890791
Emailtcarrico@neuraxis.com
Phone8126890791
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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB327NSS203 [Previous]
HIBCCB960NSS203 [Primary]
HIBCCB960NSS2031 [Package]
Contains: B960NSS203
Package: Box [10 Units]
In Commercial Distribution
HIBCCB960NSS2032 [Package]
Contains: B960NSS203
Package: BOX [20 Units]
In Commercial Distribution
HIBCCB960NSS2033 [Package]
Contains: B960NSS203
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-09
Device Publish Date2020-11-09

Devices Manufactured by Innovative Health Solutions, Inc

B960NSS2001 - NSS-2 Bridge2021-02-22 The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of op
B960NSS201 - NSS NeuroStim2021-02-09 The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
B960NSS2031 - NSS IB-STIM2021-02-09The 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.
B960NSS2031 - NSS IB-STIM2021-02-09 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population
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