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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K253061

510(k) cleared

Portable Neuromodulation Stimulator (PoNS)

Helius Medical, Inc. · May 13, 2026 · K253061

FDA cleared the Portable Neuromodulation Stimulator (PoNS) from Helius Medical, Inc. on May 13, 2026 under K253061, a traditional 510(k). The device falls under product code QCF, Electrical Tongue Stimulator To Treat Motor Deficits, regulated at 21 CFR 882.5889 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 22, 2025. The decision came 233 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Helius Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253061?

K253061 is the FDA 510(k) for Portable Neuromodulation Stimulator (PoNS), submitted by Helius Medical, Inc.. FDA's decision date was May 13, 2026, under product code QCF (Electrical Tongue Stimulator To Treat Motor Deficits).

Who makes the Portable Neuromodulation Stimulator (PoNS)?

Helius Medical, Inc., based in Newton, PA, is the applicant of record for K253061.

How long did the K253061 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on May 13, 2026, 233 days later.

← All decisions in May 2026