Portable Neuromodulation Stimulator (PoNS)
Device Facts
| Record ID | K253061 |
|---|---|
| Device Name | Portable Neuromodulation Stimulator (PoNS) |
| Applicant | Helius Medical, Inc. |
| Product Code | QCF · Neurology |
| Decision Date | May 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5889 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
Special Controls
In combination with the general controls of the FD&C Act, the electrical tongue nerve stimulator to treat motor deficits is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical, mechanical, and thermal safety of the device. (3) Non-clinical performance testing must characterize the electrical stimulation parameters of the device. (4) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users as part of cybersecurity review. (5) Labeling must include: (i) A detailed summary of the device's technical parameters; (ii) Instructions for use; (iii) Cleaning, storage, and charging instructions; and (iv) Disposal instructions.
