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Solax Electric Scooter (Models: S204311M, S204161, S204143)

by Dongguan Prestige Sporting Goods Co., Ltd.

510(k) K190737

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190737 Date10 May 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
INI
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Solax Electric Scooter is a motorized 3-wheeled vehicle classified under device class 2 and product code INI. It is designated as a Physical Medicine device based on its regulatory classification and intended use within that specialty.

The device received FDA 510(k) clearance (K190737) on May 10, 2021, through the Traditional pathway, and was found substantially equivalent to a predicate device. It is manufactured by Dongguan Prestige Sporting Goods Co., Ltd. and is regulated under 21 CFR 890.3800.

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