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Heartway Power Mobility Scooter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132855

by Heartway Medical Products Co., Ltd.

Identifiers

510(k) Number
K132855 FDA 510(k)
FDA Product Code
INI FDA 510(k)

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)

The Heartway Power Mobility Scooter is a motorized three-wheeled vehicle designed for personal mobility assistance. It is classified as a mobility aid intended to provide users with enhanced independence and mobility in indoor and outdoor environments, supporting individuals with limited mobility or physical disabilities.

This device is supplied as a reusable mobility solution, intended for use in clinical and home settings. It is regulated under FDA 510(k) clearance and the Medical Device Regulation (MDR), with multiple registration numbers and FEI codes listed. The scooter is not indicated for MRI use and must be stored in accordance with manufacturer guidelines to ensure proper functionality and safety.

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: Heartway, IMC - Heartway Mobility Medical Electric Power Chairs & Scooters, Heartway Medical Products Co., Ltd.| Taiwan Manufacturers and Suppliers ..., IMC-Heartway - Latexpedic

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Heartway Medical Products Co., Ltd.

Sources (2)

  • FDA 510(k) K132855 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026