Cleared Traditional

Mobility Scooter (S3)

K253643 · Shenzhen Zhimahuaerkai Technology Co., Ltd. · Physical Medicine

Feb 2026

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K253643 is an FDA 510(k) clearance for the Mobility Scooter (S3), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Shenzhen Zhimahuaerkai Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 18, 2026, 91 days after receiving the submission on November 19, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number	K253643 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2025
Decision Date	February 18, 2026
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement