Mobility Scooter - S1 PLUS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231472

by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd

Identifiers

510(k) Number: K231472 FDA 510(k)
FDA Product Code: INI FDA 510(k)
Models / Variants: S1 SPORT FDA 510(k)EUDAMED
S1 PLUS FDA 510(k)EUDAMED
MAX SPORT FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.3800 FDA 510(k)
Regulation Number: 890.3800 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a Motorized 3-Wheeled Vehicle designed to assist individuals with limited mobility in indoor and outdoor environments. It provides powered propulsion for users who require enhanced mobility support, featuring three wheels for stability and maneuverability across various terrains.

The Mobility Scooter (S1 Sport, S1 Plus, Max Sport) is intended for single-use or reusable applications in home, community, and clinical settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The device is not sterile and must be cleaned and maintained according to manufacturer guidelines. Multiple model variants are available, each with distinct specifications for user needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) (K231472) — FDA 510(k ..., K231472 - Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) - FDA 510 (k), Folding Seniors Mobility Motorized Scooters Manufacturers, Mobility Scooter Manufacturer | Globalsweetrich

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K231472	Class II	Active

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Manufacturer

Manufacturer: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd
FDA Applicant: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

Sources (2)

FDA 510(k) K231472 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026