Cleared Traditional

HS186B Scooter

K222711 · Suzhou Master Machinery Manufacturing Co.,Ltd · Physical Medicine
Jan 2023
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K222711 is an FDA 510(k) clearance for the HS186B Scooter, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan City, CN). The FDA issued a Cleared decision on January 9, 2023, 123 days after receiving the submission on September 8, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K222711 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2022
Decision Date January 09, 2023
Days to Decision 123 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INI — Vehicle, Motorized 3-wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3800

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