510(k) K253061
K253061 is an FDA 510(k) premarket notification submitted by Helius Medical, Inc. for the device "Portable Neuromodulation Stimulator (PoNS)". The FDA issued a decision of Substantially Equivalent on May 13, 2026. The device falls under product code QCF (Electrical Tongue Stimulator To Treat Motor Deficits), a Class II device regulated under 21 CFR 882.5889. Helius Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2026
- Date Received
- Sep 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Device Class
- Class II
- Regulation Number
- 882.5889
- Review Panel
- NE
- Submission Type
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.