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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 / K262553

510(k) cleared

MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)

Zhejiang Kailang Technology Co., Ltd. · Sep 29, 2026 · K262553

FDA cleared the MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A) from Zhejiang Kailang Technology Co., Ltd. on Sep 29, 2026 under K262553, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jul 24, 2026. The decision came 67 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhejiang Kailang Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262553?

K262553 is the FDA 510(k) for MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A), submitted by Zhejiang Kailang Technology Co., Ltd.. FDA's decision date was Sep 29, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)?

Zhejiang Kailang Technology Co., Ltd., based in Yongkang, is the applicant of record for K262553.

How long did the K262553 review take?

FDA received the submission on Jul 24, 2026 and issued its decision on Sep 29, 2026, 67 days later.

← All decisions in September 2026