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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 / K262213

510(k) cleared

Power Mobility Scooter (MA03)

Nanjing Mijo Technology Co., Ltd. · Sep 29, 2026 · K262213

FDA cleared the Power Mobility Scooter (MA03) from Nanjing Mijo Technology Co., Ltd. on Sep 29, 2026 under K262213, 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 Jun 30, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nanjing Mijo Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253936 (Power Mobility Scooter (MJMA01, MJMA02)).

Questions & Answers

What did FDA clear under K262213?

K262213 is the FDA 510(k) for Power Mobility Scooter (MA03), submitted by Nanjing Mijo Technology Co., Ltd.. FDA's decision date was Sep 29, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Power Mobility Scooter (MA03)?

Nanjing Mijo Technology Co., Ltd., based in Nanjing, is the applicant of record for K262213.

How long did the K262213 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Sep 29, 2026, 91 days later.

← All decisions in September 2026

Sources