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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / February 2026 / K253599

510(k) cleared

Electric Wheelchair (W-A807, W-A807L)

Ningbo Shenyu Medical Equipment Co.,Ltd · Feb 17, 2026 · K253599

FDA cleared the Electric Wheelchair (W-A807, W-A807L) from Ningbo Shenyu Medical Equipment Co.,Ltd on Feb 17, 2026 under K253599, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 18, 2025. The decision came 91 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 Ningbo Shenyu Medical Equipment Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253599?

K253599 is the FDA 510(k) for Electric Wheelchair (W-A807, W-A807L), submitted by Ningbo Shenyu Medical Equipment Co.,Ltd. FDA's decision date was Feb 17, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (W-A807, W-A807L)?

Ningbo Shenyu Medical Equipment Co.,Ltd, based in Yuyao, is the applicant of record for K253599.

How long did the K253599 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Feb 17, 2026, 91 days later.

← All decisions in February 2026