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The Tracker / September 2026 / K261859

510(k) cleared

Electric Scooter (FDB08, FDB08A, FDB12)

Anhui JBH Medical Apparatus Co., Ltd. · Sep 19, 2026 · K261859

FDA cleared the Electric Scooter (FDB08, FDB08A, FDB12) from Anhui JBH Medical Apparatus Co., Ltd. on Sep 19, 2026 under K261859, 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 4, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Anhui JBH Medical Apparatus Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261859?

K261859 is the FDA 510(k) for Electric Scooter (FDB08, FDB08A, FDB12), submitted by Anhui JBH Medical Apparatus Co., Ltd.. FDA's decision date was Sep 19, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Electric Scooter (FDB08, FDB08A, FDB12)?

Anhui JBH Medical Apparatus Co., Ltd., based in Chuzhou, is the applicant of record for K261859.

How long did the K261859 review take?

FDA received the submission on Jun 4, 2026 and issued its decision on Sep 19, 2026, 107 days later.

← All decisions in September 2026