510(k) · Cleared
ClearedPortable Neuromodulation Stimulator (PoNS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helius Medical, Inc. · QCF Electrical Tongue Stimulator To Treat Motor Deficits
Cleared on May 13, 2026 as substantially equivalent to DEN200050 (Helius Medical, Inc., 2021) after a 233-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- May 13, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- QCF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200050 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200050 Portable Neuromodulation Stimulator (PoNS)Helius Medical, Inc. · 2021
- This deviceK253061 Portable Neuromodulation Stimulator (PoNS)Helius Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200050 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | 2021 | — |
| 0 (this device) | K253061 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | 2026 | — |
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 QCF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN200050 | Portable Neuromodulation Stimulator (PoNS)Summary page 5…E: Electrical tongue nerve stimulator to treat motor deficits CLASSIFICATION: Class II PRODUCT CODE: QCF PREDICATE DEVICE: Portable Neuromodulation Stimulator (PoNSTM) (DEN200050) DEVICE DESCRIPTION Both the current PoNS (Portable Neuromodulation Stimulator) device and the predicate PoNS device (authoriz… | 2021 |
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.
How does its category compare?
All QCF devicesQCF Electrical Tongue Stimulator To Treat Motor Deficits: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QCF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QCF
Too few QCF 510(k)s in any year since 2007 to give a median.
Recalls per year · QCF
No recall names QCF since 2007.
Adverse event reports per year · QCF
No MAUDE report names QCF since 2007.
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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PoNS device is indicated for use as a treatment of dynamic gait deficit due to chronic symptoms from stroke and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253061: Portable Neuromodulation Stimulator (PoNS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253061
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026