Portable Folding Electric Wheelchair DC01
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212092 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 Portable Folding Electric Wheelchair DC01 is a powered wheelchair designed for mobility assistance. It combines electric propulsion with a foldable frame to facilitate transport and storage, catering to users requiring enhanced independence in indoor and outdoor environments.
This device is supplied as a reusable, non-sterile medical product and is classified as Class II under FDA regulations. It features a lightweight carbon fiber frame, with a net weight of 20.1 kg, and is intended for use in clinical and home settings. The device holds FDA 510(k) clearance and EU MDR compliance, with registration number 9615350 and 9615410. It is intended for use in physical medicine applications and is not MRI-safe.
Frequently asked questions
Is this wheelchair designed for single-use or can it be reused after cleaning and maintenance?
The Portable Folding Electric Wheelchair (Model DC01) is explicitly labeled as a reusable medical device. Since it is non-sterile and intended for clinical and home use, it must be cleaned and maintained according to manufacturer guidelines to ensure safe, repeated use. The reusable classification aligns with its design for long-term mobility assistance rather than disposable applications.
What materials is the wheelchair’s frame made of, and how does that affect its weight and portability?
The wheelchair features a lightweight carbon fiber frame, which contributes to its compact design and reduced weight of 20.1 kg. Carbon fiber enhances durability while minimizing bulk, making it easier to fold and transport compared to traditional steel frames. This material choice balances strength, weight savings, and portability—ideal for users who need to move the device frequently.
How does the folding mechanism impact its usability in clinical or home settings?
The foldable frame of the DC01 is specifically designed to simplify transport and storage, which is critical for clinical environments (e.g., hospitals, rehab centers) or home use where space is limited. When folded, it can be easily stored in vehicles, elevators, or compact storage areas, reducing barriers to mobility assistance without compromising functionality when deployed.
Are there different size or model options available for this wheelchair, or is it a one-size-fits-all design?
The provided data does not specify multiple size or model variants for the DC01. It is described as a single model (DC01) with a standardized lightweight carbon fiber frame and electric propulsion system. For users requiring adjustments (e.g., seat width, leg length), customization would likely need to be addressed through manufacturer modifications or accessories, not inherent model variations.
What storage or environmental conditions should be followed to maintain the wheelchair’s performance and longevity?
While the data does not detail specific storage instructions, the wheelchair’s non-sterile, reusable classification and electric components imply it should be stored in a dry, temperature-controlled environment to prevent moisture damage or battery degradation. Users should follow the manufacturer’s guidelines for battery charging, frame cleaning, and avoiding exposure to extreme conditions (e.g., direct sunlight, freezing temperatures) to ensure safe, long-term operation.
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: Jbh Medical Lightweight Carbon Fiber Frame Electric Wheelchair DC01, Carbon Fiber Electric Wheelchair DC01 - jbhmedical.com, DC01 - Anhui Jbh Medical Apparatus Co., Ltd., 2026 DC01 streamline electric wheelchair - Anhui Jbh Medical Apparatus ...
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 | K212092 | Class II | Active |
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Manufacturer
- Manufacturer
- Anhui Jbh Medical Apparatus Co., Ltd
- FDA Applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
Sources (2)
- FDA 510(k) K212092 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026