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FDA opens comment on an electronic submission template for IDE applications Vincora wins an IDE to implant artificial chordae on a beating heart OrthoPediatrics clears a retrograde femur nail in 7 to 11 mm diameters Stryker closes its ZuriMED deal and takes FiberLocker into sports medicine X9 wins a Breakthrough designation for power-assisted dialysis cannulation adsilico raises 10 million pounds to test implants on virtual patients Smith+Nephew and J&J ortho merger talks collapse over who would run it Labcorp agrees to buy Millennium Health and its drug monitoring business Coreline Soft clears aortic measurement software, its 13th US clearance FDA opens comment on an electronic submission template for IDE applications Vincora wins an IDE to implant artificial chordae on a beating heart OrthoPediatrics clears a retrograde femur nail in 7 to 11 mm diameters Stryker closes its ZuriMED deal and takes FiberLocker into sports medicine X9 wins a Breakthrough designation for power-assisted dialysis cannulation adsilico raises 10 million pounds to test implants on virtual patients Smith+Nephew and J&J ortho merger talks collapse over who would run it Labcorp agrees to buy Millennium Health and its drug monitoring business Coreline Soft clears aortic measurement software, its 13th US clearance

The Tracker / October 2026 / K263257

510(k) cleared

Electrically Powered Wheelchair (YC-01)

Yurob Rehabilitation Medical Co., Ltd. · Oct 13, 2026 · K263257

FDA cleared the Electrically Powered Wheelchair (YC-01) from Yurob Rehabilitation Medical Co., Ltd. on Oct 13, 2026 under K263257, a special 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 Sep 17, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Yurob Rehabilitation Medical Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K253600 (Scooter (YD-03)), K253980 (Electrically Powered Wheelchair (Model YC-01)).

Questions & Answers

What did FDA clear under K263257?

K263257 is the FDA 510(k) for Electrically Powered Wheelchair (YC-01), submitted by Yurob Rehabilitation Medical Co., Ltd.. FDA's decision date was Oct 13, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electrically Powered Wheelchair (YC-01)?

Yurob Rehabilitation Medical Co., Ltd., based in Kunshan, is the applicant of record for K263257.

How long did the K263257 review take?

FDA received the submission on Sep 17, 2026 and issued its decision on Oct 13, 2026, 26 days later.

← All decisions in October 2026

Sources