Heartway Attendant-Controlled Power Chair, TC1
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071006 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)
The Heartway Attendant-Controlled Power Chair, TC1 is a powered wheelchair. It is a battery operated, indoor/outdoor electric scooter with a base, four wheels, a seat, armrests, and a front basket.
The device is supplied as a single unit and is intended to provide mobility to persons restricted to a seated position. It is classified as a Class 2 device under regulation 890.3860 and has a product code of ITI. The device has been cleared by the FDA with a 510(k) number of K071006.
Frequently asked questions
What is the Heartway Attendant-Controlled Power Chair, TC1 used for?
The Heartway Attendant-Controlled Power Chair, TC1 is intended to provide mobility to persons restricted to a seated position.
Is the Heartway Attendant-Controlled Power Chair, TC1 supplied as a single unit?
Yes, the device is supplied as a single unit, including a base, four wheels, a seat, armrests, and a front basket.
What is the regulatory classification of the Heartway Attendant-Controlled Power Chair, TC1?
The device is classified as a Class 2 device under regulation 890.3860 with a product code of ITI.
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 Attendant-controlled Power Chair, Tc1, PDF HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 510(k) K071006 - fda.report, PDF ?-IEARTWAY MEDICAL PRODUCTS CO.,LTD. ii
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071006 | Class II | Active |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co., Ltd.
Sources (1)
- FDA 510(k) K071006 24 fields · synced Oct 6, 2026