Skip to content

Magnesium Alloy Scooter RS100

by Taizhou reach technology co., Ltd.

510(k) K250533

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250533↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK250533 Date14 May 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 Magnesium Alloy Scooter RS100 is a motorized three-wheeled vehicle designed for mobility assistance. Classified as a Class II medical device under FDA regulations, it is intended for use in physical medicine settings to aid individuals with limited mobility.

This device is supplied as a reusable, non-sterile product and is regulated under FDA 510K clearance and MDR compliance. It is manufactured by Taizhou Reach Technology Co., Ltd., with a registration number of 3033905189, and falls under the regulatory category of 890.3800. The scooter is intended for use in physical therapy and rehabilitation environments.

Other devices from Taizhou reach technology co., Ltd.

Questions

AI-generated answers, 18 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 primary use case for the Magnesium Alloy Scooter (RS100) in clinical settings?

    The Magnesium Alloy Scooter (RS100) is designed specifically for mobility assistance in physical medicine and rehabilitation environments. It is classified as a Class II medical device under FDA regulations and is intended to aid individuals with limited mobility, such as those recovering from injuries or managing chronic mobility challenges. The device’s regulatory filing under the Physical Medicine advisory committee confirms its role in therapeutic and rehabilitative care.

  • Is the Magnesium Alloy Scooter (RS100) intended for single-use or reusable applications?

    The Magnesium Alloy Scooter (RS100) is explicitly supplied as a reusable device. It is not sterile and is not intended for single-use, meaning it can be cleaned and used repeatedly in clinical or home settings. This aligns with its classification as a mobility aid rather than a disposable medical item.

  • How is the regulatory compliance of the Magnesium Alloy Scooter (RS100) demonstrated?

    The device’s compliance is demonstrated through FDA 510K clearance and MDR (Medical Device Regulation) compliance, as noted in the data. It was classified as Substantially Equivalent (SESE) under the Physical Medicine advisory committee (PM) and falls under the regulatory product code INI and category 890.3800. The clearance was granted via a traditional 510(k) review, confirming its adherence to FDA standards for motorized mobility aids.

  • What manufacturing and contact details are provided for the Magnesium Alloy Scooter (RS100)?

    The scooter is manufactured by Taizhou Reach Technology Co., Ltd., located at #18 Xiangrong Rd., Chengqu Industrial Zone, Taixing City, China. For inquiries, the contact person listed is Rong Fan. The device holds a Chinese registration number (FEI) of 3033905189, which may be relevant for international procurement or compliance verification.