WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / December 2025 / K251159

510(k) cleared

Power wheelchair

Zhenjiang Assure Medical Equipment Co., Ltd. · Dec 22, 2025 · K251159

FDA cleared the Power wheelchair from Zhenjiang Assure Medical Equipment Co., Ltd. on Dec 22, 2025 under K251159, 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 Apr 15, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhenjiang Assure Medical Equipment Co., Ltd. has 5 other decisions in the tracker over the last 12 months: K261919 (Multifunctional wheelchair (YJ-059)), K260141 (Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)), K260144 (Reclining wheelchair (YJ-013L)), K260145 (YJ-K1K2 Wheelchair (YJ-013F)).

Questions & Answers

What did FDA clear under K251159?

K251159 is the FDA 510(k) for Power wheelchair, submitted by Zhenjiang Assure Medical Equipment Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Power wheelchair?

Zhenjiang Assure Medical Equipment Co., Ltd., based in Zhenjiang, is the applicant of record for K251159.

How long did the K251159 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Dec 22, 2025, 251 days later.

← All decisions in December 2025