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Ib-Stim

FDA UDI

Class II (US FDA UDI)

by Key Electronics, Inc.

Identity

Trade Name
IB-STIM FDA UDI
Generic Name
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI
Device Name
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. FDA UDI
Model / Reference
IB-STIM FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
01-1020 FDA UDI
Primary DI / UDI-DI
B327NSS203 FDA UDI
FDA Product Code
QHH FDA UDI
GMDN Term
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

Ib-Stim by Key Electronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Key Electronics, Inc.

Sources (1)

  • FDA UDI 4f2e85e4-61c6-4e32-9605-57bbb68257a3 34 fields · synced May 30, 2026