IB-Stim has a unique FDA regulatory classification

CFR Title 21: 876.5340

What IB-Stim is:

  • A PENFS (Percutaneous Electrical Nerve Field Stimulator) device that is non-implantable and stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain.

What IB-Stim is not:

  • PENS (Peripheral Electrical Nerve Stimulation) – Placed at the site of pain.

  • PNS (Peripheral Nerve Stimulation) – Placed at the site of pain.
  • PNFS (Peripheral Nerve Field Stimulation) – Placed at the site of pain.
  • TENS (Trancutaneous Electrical Nerve Stimulation) – Superficial stimulation of nerves at the site of pain or remotely.
  • CES (Cranial Electrotherapy Nerve Stimulation) – Electrical stimulation with TENS electrodes attached to anatomical positions around the head/scalp.

A New Standard Of Care

*The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS DEN180057.