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Ruike Model 3331

by Shanghai Ruike Sports Goods Co., Ltd.

510(k) K062676

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 NumberK062676 Date14 Dec 2006ClearedStatusActive

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  • Withdrawn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 Ruike Model 3331 is a motorized 3-wheeled vehicle designed for indoor and outdoor transportation. It provides mobility for disabled or elderly persons who are limited to a seated position. The device is classified as a Class II medical device under product code INI.

The Ruike Model 3331 is supplied by Shanghai Ruike Sports Goods Co., Ltd. and received FDA 510(k) clearance with decision code SESE on December 14, 2006. It is substantially equivalent to the LANDLEX P10OX (K060042) manufactured by Besteam Technology Inc. The device is intended for use as a transportation device for individuals requiring seated mobility assistance.

Other devices from Shanghai Ruike Sports Goods Co., Ltd.

Questions

AI-generated answers, 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.

  • What is the Ruike Model 3331 used for?

    The Ruike Model 3331 is a motorized 3-wheeled vehicle designed for indoor and outdoor transportation, providing mobility assistance for disabled or elderly persons who are limited to a seated position.

  • How is the Ruike Model 3331 supplied?

    The Ruike Model 3331 is supplied by Shanghai Ruike Sports Goods Co., Ltd. and received FDA 510(k) clearance with decision code SESE on December 14, 2006.

  • Is the Ruike Model 3331 reusable or single-use?

    The device information does not specify whether the Ruike Model 3331 is designed for single-use or multiple uses. This detail would be available in the product's instructions for use provided by the manufacturer.

  • What is the regulatory classification of the Ruike Model 3331?

    The Ruike Model 3331 is classified as a Class II medical device under product code INI and is substantially equivalent to the LANDLEX P10OX (K060042) manufactured by Besteam Technology Inc.