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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 / January 2026 / K253408

510(k) cleared

CoolTone

Zimmer Medizinsysteme GmbH · Jan 16, 2026 · K253408

FDA cleared the CoolTone from Zimmer Medizinsysteme GmbH on Jan 16, 2026 under K253408, a traditional 510(k). The device falls under product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning, 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 30, 2025. The decision came 108 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 Zimmer Medizinsysteme GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253408?

K253408 is the FDA 510(k) for CoolTone, submitted by Zimmer Medizinsysteme GmbH. FDA's decision date was Jan 16, 2026, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the CoolTone?

Zimmer Medizinsysteme GmbH, based in Neu-Elm, is the applicant of record for K253408.

How long did the K253408 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 16, 2026, 108 days later.

← All decisions in January 2026