Cleared Traditional

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)

K231472 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Physical Medicine

Jul 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K231472 is an FDA 510(k) clearance for the Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 19, 2023, 58 days after receiving the submission on May 22, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number	K231472 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2023
Decision Date	July 19, 2023
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF