# DEN200050: Portable Neuromodulation Stimulator (PoNS)

- Pathway: De Novo (Direct)
- Applicant: Helius Medical, Inc.
- Decided: Mar 26, 2021 after 234 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253061: Portable Neuromodulation Stimulator (PoNS) (2026), 0 descendants of its own

## Indications for use
The PoNS device is indicated for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis 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/DEN200050
Methodology: https://510kreport.com/methodology