# DEN180057: IB-Stim

- Pathway: De Novo (Direct)
- Applicant: Innovative Health Solutions (Ihs), Inc.
- Decided: Jun 7, 2019 after 225 days
- Product code: QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs))
- Device class: 2
- Regulation: 21 CFR 876.5340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K241533: NeurAxis IB-Stim (01-1020) (2024), 2 descendants of its own
- K250451: NeurAxis IB-Stim (01-1020) (2025), 1 descendant of its own
- K252024: NeurAxis IB-Stim (01-1020) (2025), 0 descendants of its own
- K230526: TEA Device (2023), 0 descendants of its own
- K202940: First Relief v1 (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN180057
Methodology: https://510kreport.com/methodology