Heartway Electrically Powered Wheelchairs
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142731 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Heartway Electrically Powered Wheelchairs are powered wheelchairs designed to provide mobility assistance to users. These devices are classified as powered wheelchairs under physical medicine regulations.
This device is authorized via FDA 510K clearance. It is manufactured by Heartway Medical Products Co., Ltd. in Taichung City, Taiwan.
Frequently asked questions
What is the primary purpose of Heartway Electrically Powered Wheelchairs?
These devices are designed to provide mobility assistance to users. They are classified as powered wheelchairs under physical medicine regulations to support individuals who require mechanical aid for movement.
How are these wheelchairs authorized for the market?
Heartway Electrically Powered Wheelchairs are authorized via FDA 510K clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of these powered wheelchairs?
The wheelchairs are manufactured by Heartway Medical Products Co., Ltd., located in Taichung City, Taiwan. The company manages the production and regulatory compliance for this product line.
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: IMC - Heartway Mobility Medical Electric Power Chairs & Scooters, IMC-Heartway Motorized Medical Mobility Powered Electric Wheelchairs ..., IMC-Heartway Motorized Medical Mobility Powered Electric Wheelchairs ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142731 | Class II | Active |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co., Ltd.
Sources (1)
- FDA 510(k) K142731 24 fields · synced Oct 6, 2026