Powered Wheelchair (PL001-9001)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252829 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 Powered Wheelchair (PL001-9001) is a physical medicine device designed to provide mobility assistance to individuals with limited mobility. It is a powered wheelchair that enables users to move independently with electric propulsion.
The device is manufactured by Suzhou KD Intelligent Device Co., Ltd. and is supplied as a non-sterile, reusable medical device. It has FDA 510(k) clearance with the K252829 number and is classified under product code ITI, regulation number 890.3860. The device is available in various sizes as indicated by the model number PL001-9001.
Frequently asked questions
What is the Powered Wheelchair (PL001-9001) designed for?
The Powered Wheelchair (PL001-9001) is a physical medicine device designed to provide mobility assistance to individuals with limited mobility, enabling users to move independently with electric propulsion.
How is the Powered Wheelchair supplied and is it sterile?
The Powered Wheelchair is supplied as a non-sterile, reusable medical device. It is manufactured by Suzhou KD Intelligent Device Co., Ltd. and requires appropriate cleaning and maintenance between uses.
What regulatory approvals does the Powered Wheelchair have?
The Powered Wheelchair has FDA 510(k) clearance with the K252829 number and is classified under product code ITI, regulation number 890.3860. It is cleared as substantially equivalent to predicate devices.
Are there different sizes or models available for the Powered Wheelchair?
The Powered Wheelchair is available in various sizes as indicated by the model number PL001-9001. The specific size options and their corresponding model numbers should be confirmed with the manufacturer for detailed specifications.
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: K252829 - Powered Wheelchair (PL001-9001) - FDA 510 (k), Powered Wheelchair (PL001-9001) | Medical Device Navigator, Suzhou KD Intelligent Device Co., Ltd. FDA 510(k) Products, Powered Wheelchair (PL001-9001) 510(k) K252829 - FDA.report, Powered Wheelchair (PL001-9001) 510(k) K252829 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252829 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suzhou KD Intelligent Device Co., Ltd.
Sources (1)
- FDA 510(k) K252829 24 fields · synced Sep 24, 2026