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

• Primary Device ID: B960NSS2031
• NIH Device Record Key: 7a772919-6c75-4ab6-86ea-7097ba69c0a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NSS IB-STIM
• Version Model Number: IB-STIM
• Catalog Number: 01-1020
• Company DUNS: 063076701
• Company Name: Innovative Health Solutions, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tom@i-h-s.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com
• Phone: 8126890791
• Email: tcarrico@neuraxis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B327NSS203 [Previous]
HIBCC	B960NSS203 [Primary]
HIBCC	B960NSS2031 [Package]; Contains: B960NSS203; Package: Box [10 Units]; In Commercial Distribution
HIBCC	B960NSS2032 [Package]; Contains: B960NSS203; Package: BOX [20 Units]; In Commercial Distribution
HIBCC	B960NSS2033 [Package]; Contains: B960NSS203; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• QHH: Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-09
• Device Publish Date: 2020-11-09

Devices Manufactured by Innovative Health Solutions, Inc

• B960NSS2001 - NSS-2 Bridge: 2021-02-22 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 NeuroStim: 2021-02-09 The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
• B960NSS2031 - NSS IB-STIM: 2021-02-09The 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-STIM: 2021-02-09 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population