Duns Number:172218799
Device Description: The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system 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.
Catalog Number
01-1020
Brand Name
IB-STIM
Version/Model Number
IB-STIM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QHH
Product Code Name
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Public Device Record Key
4f2e85e4-61c6-4e32-9605-57bbb68257a3
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
September 18, 2019
Package DI Number
B327NSS2032
Quantity per Package
20
Contains DI Package
B327NSS203
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX