IB-STIM 01-1020

GUDID B327NSS2032

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 weighing approximately 5 grams 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.

KEY ELECTRONICS, INC.

CNS-modulation periauricular nerve percutaneous electrical stimulator

• Primary Device ID: B327NSS2032
• NIH Device Record Key: 4f2e85e4-61c6-4e32-9605-57bbb68257a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IB-STIM
• Version Model Number: IB-STIM
• Catalog Number: 01-1020
• Company DUNS: 172218799
• Company Name: KEY ELECTRONICS, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B327NSS203 [Primary]
HIBCC	B327NSS2031 [Package]; Contains: B327NSS203; Package: BOX [10 Units]; In Commercial Distribution
HIBCC	B327NSS2032 [Package]; Contains: B327NSS203; Package: BOX [20 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: 2019-10-07
• Device Publish Date: 2019-09-18

Devices Manufactured by KEY ELECTRONICS, INC.

• B327NSS201 - NSS Neurostim: 2019-10-23 The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of
• B327NSS202 - NSS MFS: 2019-10-23 The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in
• B327NSS2032 - IB-STIM: 2019-10-07The 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 weighing approximately 5 grams 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.
• B327NSS2032 - IB-STIM: 2019-10-07 The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population
• B327NSS200 - NSS-2: 2019-10-07 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