510(k) · Cleared
ClearedFirst Relief v1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · QHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Cleared on Dec 29, 2020 as substantially equivalent to DEN180057 (Innovative Health Solutions (Ihs), Inc., 2019) after a 90-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Dec 29, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- QHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180057 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180057 IB-StimInnovative Health Solutions (Ihs), Inc. · 2019
- This deviceK202940 First Relief v1Dyansys, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019 | — |
| 0 (this device) | K202940 | First Relief v1 | Dyansys, Inc. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QHH device
- #1 K250451 NeurAxis IB-Stim (01-1020)score 12.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180057 | IB-StimSummary page 4…ef v1 Classification Name :Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome Product Code :QHH 2. Predicate Device: DEN Number: DEN180057 Model Name: IB - Stim Manufacturer: Innovative Health Solutions.Inc., 3. Device Description: The First Relief v1 is designed to… | 2019 |
| † | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN180057.
How does its category compare?
All QHH devicesQHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QHH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHH
Too few QHH 510(k)s in any year since 2007 to give a median.
Recalls per year · QHH
No recall names QHH since 2007.
Adverse event reports per year · QHH
2in 2023
MAUDE reports naming product code QHH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202940: First Relief v1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202940
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026