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Sign in to claim this brandSuzhou KD Intelligent Device Co., Ltd.
US
Last updated May 23, 2026
What Suzhou KD Intelligent Device Co., Ltd. makes
Suzhou KD Intelligent Device Co., Ltd. manufactures occupant-controlled electric-motor-driven wheelchairs, designed for mobility assistance. These devices are intended for individuals requiring powered mobility solutions in various environments, including indoor and outdoor settings.
The company’s products are classified as Class II medical devices under regulatory frameworks. These devices are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. medical device compliance requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Suzhou KD Intelligent Device Co., Ltd. manufacture?
Suzhou KD Intelligent Device Co., Ltd. specializes in occupant-controlled electric-motor-driven wheelchairs. These devices are designed to provide powered mobility assistance for individuals who require mobility support in both indoor and outdoor environments. The focus is on enhancing independence and accessibility for users.
Where is Suzhou KD Intelligent Device Co., Ltd. based?
The company is based in the United States. While the name suggests a Chinese origin, the operational headquarters and manufacturing presence are located within the U.S., aligning with its regulatory and market focus.
How are the devices manufactured by Suzhou KD Intelligent Device Co., Ltd. classified under regulatory standards?
The devices produced by Suzhou KD Intelligent Device Co., Ltd. are classified as Class II medical devices. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and benefits. Class II devices typically require special controls to ensure safety and effectiveness beyond general controls, such as performance standards or post-market surveillance.
Which regulatory registries list the devices manufactured by Suzhou KD Intelligent Device Co., Ltd.?
The devices manufactured by Suzhou KD Intelligent Device Co., Ltd. are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries are used to track and monitor medical devices to ensure compliance with U.S. regulatory requirements, including safety, performance, and traceability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 544250984
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kd | PL001 | FDA UDI | Class II | Active |
| Kd | PL001-3003 | FDA UDI | Class II | Active |
| Kd | PL001-2010 | FDA UDI | Class II | Active |
| Kd | PL001-5000 | FDA UDI | Class II | Active |
| Kd | PL001-8000 | FDA UDI | Class II | Active |
| Kd | PL001-2000 | FDA UDI | Class II | Active |
| Kd | PL001-4000 | FDA UDI | Class II | Active |
| Kd | PL001-7000 | FDA UDI | Class II | Active |
| Kd | PL001-2004 | FDA UDI | Class II | Active |
| Kd | PL001-1000 | FDA UDI | Class II | Active |
| Kd | PL001-6000 | FDA UDI | Class II | Active |
| Kd | PL001-3000 | FDA UDI | Class II | Active |
| Kd | PL001-8002 | FDA UDI | Class II | Active |
| Kd | PL001-7002 | FDA UDI | Class II | Active |
| Kd | PL001-3005 | FDA UDI | Class II | Active |
| Kd | PL001-7003 | FDA UDI | Class II | Active |
| Kd | PL001-4001 | FDA UDI | Class II | Active |
| Kd | PL001-2003 | FDA UDI | Class II | Active |
| Powered Wheelchair (PL001-9001) | K252829 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Suzhou Kd Intelligent Device Co., Ltd. TaiCang City Jiangsu · CN FEI 3008466210