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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 / September 2026 / K262241

510(k) cleared

Electric Wheelchair (0080)

Xuzhou Heabens Medical Technology Co., Ltd. · Sep 29, 2026 · K262241

FDA cleared the Electric Wheelchair (0080) from Xuzhou Heabens Medical Technology Co., Ltd. on Sep 29, 2026 under K262241, 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 Jul 1, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xuzhou Heabens Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262241?

K262241 is the FDA 510(k) for Electric Wheelchair (0080), submitted by Xuzhou Heabens Medical Technology Co., Ltd.. FDA's decision date was Sep 29, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (0080)?

Xuzhou Heabens Medical Technology Co., Ltd., based in Xuzhou, is the applicant of record for K262241.

How long did the K262241 review take?

FDA received the submission on Jul 1, 2026 and issued its decision on Sep 29, 2026, 90 days later.

← All decisions in September 2026