# K230526: TEA Device

- Pathway: 510(k) (Traditional)
- Applicant: Transtimulation Research, Inc.
- Decided: Sep 14, 2023 after 199 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
Longest line of descent: 1 generation back to DEN180057 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180057: IB-Stim, Innovative Health Solutions (Ihs), Inc. (2019) Summary page 5.

## Indications for use
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VII, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.

Source page: https://510kreport.com/device/K230526
Methodology: https://510kreport.com/methodology