# K253061: Portable Neuromodulation Stimulator (PoNS)

- Pathway: 510(k) (Traditional)
- Applicant: Helius Medical, Inc.
- Decided: May 13, 2026 after 233 days
- Product code: QCF (Electrical Tongue Stimulator To Treat Motor Deficits)
- Device class: 2
- Regulation: 21 CFR 882.5889
- 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 DEN200050 (2021). 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)
- DEN200050: Portable Neuromodulation Stimulator (PoNS), Helius Medical, Inc. (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253061
Methodology: https://510kreport.com/methodology