# K202940: First Relief v1

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: Dec 29, 2020 after 90 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 4.

## Indications for use
The First Relief v1 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 First Relief v1 is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to Cranial Nerves V, VII, IX and X, and the occipital nerves identified by trans-illumination, as an aid in the reduction of pain when combined with other therapies for IBS.

Source page: https://510kreport.com/device/K202940
Methodology: https://510kreport.com/methodology