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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 / June 2026 / K252816

510(k) cleared

High Tone Power therapy (HiToP) (Model: HiToP PNP)

Mohammadali Nezakati · Jun 2, 2026 · K252816

FDA cleared the High Tone Power therapy (HiToP) (Model: HiToP PNP) from Mohammadali Nezakati on Jun 2, 2026 under K252816, a traditional 510(k). The device falls under product code IPF, Stimulator, Muscle, Powered, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 4, 2025. The decision came 271 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 Mohammadali Nezakati in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252816?

K252816 is the FDA 510(k) for High Tone Power therapy (HiToP) (Model: HiToP PNP), submitted by Mohammadali Nezakati. FDA's decision date was Jun 2, 2026, under product code IPF (Stimulator, Muscle, Powered).

Who makes the High Tone Power therapy (HiToP) (Model: HiToP PNP)?

Mohammadali Nezakati, based in Sherman Oaks, CA, is the applicant of record for K252816.

How long did the K252816 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Jun 2, 2026, 271 days later.

← All decisions in June 2026