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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 / November 2025 / K253478

510(k) cleared

Motive Muscle Stimulator for Lower Back (OT01-1003)

Motive Health, Inc. · Nov 6, 2025 · K253478

FDA cleared the Motive Muscle Stimulator for Lower Back (OT01-1003) from Motive Health, Inc. on Nov 6, 2025 under K253478, a traditional 510(k) reviewed through the Third Party Review Program. 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 Oct 14, 2025. The decision came 23 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253478?

K253478 is the FDA 510(k) for Motive Muscle Stimulator for Lower Back (OT01-1003), submitted by Motive Health, Inc.. FDA's decision date was Nov 6, 2025, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the Motive Muscle Stimulator for Lower Back (OT01-1003)?

Motive Health, Inc., based in Tempe, AZ, is the applicant of record for K253478.

How long did the K253478 review take?

FDA received the submission on Oct 14, 2025 and issued its decision on Nov 6, 2025, 23 days later.

← All decisions in November 2025