Power Wheelchair (N5919 Series)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253806 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 Power Wheelchair (N5919 Series) is a Class II medical device classified under Powered Wheelchair (Regulation Number 21 CFR 890.3860) and Wheelchair, Powered (OpenFDA). It is designed as a motorized mobility aid intended to assist individuals with limited mobility in indoor and outdoor environments by providing propulsion through electric drive systems. This device is engineered to enhance independence and mobility for users requiring powered assistance.
The Power Wheelchair (N5919 Series) is supplied as a reusable medical device and is intended for use in clinical, home, and community settings. It is regulated under FDA 510(k) clearance (K253806) and MDR (Medical Device Regulation) with a Special 510(k) review by the Physical Medicine Advisory Committee. The device is manufactured by Zhejiang Innuovo Rehabilitation Devices Co., Ltd., and is assigned the product code ITI. No sterility or single-use specifications are noted in the regulatory data.
Frequently asked questions
Is this power wheelchair designed for single-use or can it be reused multiple times?
The Power Wheelchair (N5919 Series) is explicitly described as a reusable medical device. It is intended for use in clinical, home, and community settings, meaning it is not meant for single-use disposal but rather for repeated use by authorized users.
What regulatory pathways were followed for this power wheelchair’s approval?
The Power Wheelchair (N5919 Series) received FDA 510(k) clearance (K253806) under a Special 510(k) review by the Physical Medicine Advisory Committee. It is also compliant with the EU Medical Device Regulation (MDR). The device is classified under 21 CFR 890.3860 and falls under the product code ITI.
Are there multiple models or sizes available for this power wheelchair?
The provided data lists multiple FEI numbers (e.g., 3014522447, 3021071770, etc.), which typically correspond to different models or configurations of the Power Wheelchair (N5919 Series). While exact specifications (e.g., wheel sizes, weight capacities) are not detailed, the variety of FEI numbers suggests a range of options may be available to accommodate different user needs.
How should this power wheelchair be stored to maintain its functionality?
The data does not specify storage conditions like temperature or humidity requirements, but since it is a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight, moisture, or extreme temperatures. Proper maintenance (e.g., battery care, mechanical checks) is implied for longevity, though specific instructions would typically be included in the manufacturer’s user manual.
Is this wheelchair intended for indoor use only, or can it also be used outdoors?
The Power Wheelchair (N5919 Series) is explicitly designed for both indoor and outdoor environments, as stated in its description. This indicates it is engineered to provide propulsion in varied settings, including homes, clinics, and community spaces.
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: Power (TV series) - Wikipedia, Power Wheelchair (N5919 series) (K253806) — FDA 510 (k) | Innolitics, K253806 FDA 510(k) - Power Wheelchair (N5919 series), PDF Zhejiang Innuovo Rehabilitation Devices Co.,Ltd ℅ Ivy Wang Consultant ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253806 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- FDA Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Sources (2)
- FDA 510(k) K253806 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026