Mobility Scooter BC-MS310
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252817 FDA 510(k)
- FDA Product Code
- INI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3800 FDA 510(k)
- Regulation Number
- 890.3800 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mobility Scooter BC-MS310 is a motorized three-wheeled vehicle designed for personal mobility assistance. It falls under the category of motorized mobility aids, intended to provide independent outdoor and indoor mobility for users with limited walking ability.
This device is supplied as a reusable, non-sterile product and is regulated under FDA 510K clearance and MDR compliance. It is intended for use in home, community, and clinical settings, with multiple registration numbers and FEI codes listed for regulatory tracking. The device is classified as Class II under FDA regulations and is authorized for distribution in accordance with 890.3800.
Frequently asked questions
What settings can the Mobility Scooter (BC-MS310) be used in, and how does its reusable design impact its suitability for these environments?
The Mobility Scooter (BC-MS310) is designed for use in home, community, and clinical settings, making it versatile for both personal and professional environments. Since it is a reusable, non-sterile device, it is ideal for shared or multi-user settings like clinics or community centers, where regular cleaning and maintenance can be performed to ensure hygiene. However, it is not intended for sterile procedures, so it should not replace sterile mobility aids in operating rooms or other sterile environments.
How do I determine if the Mobility Scooter (BC-MS310) is appropriate for my patient’s mobility needs, given its classification and regulatory background?
The Mobility Scooter (BC-MS310) is classified as a Class II medical device under FDA regulations and is substantially equivalent to predicate devices, as confirmed by its FDA 510(k) clearance (K252817) and MDR compliance. It is specifically designed for users with limited walking ability, providing outdoor and indoor mobility assistance. Clinicians should assess whether the patient’s mobility restrictions align with the scooter’s intended use—supporting independent movement in non-sterile environments like homes or rehabilitation centers.
Are there multiple models or configurations of the Mobility Scooter (BC-MS310), and if so, how can I identify the correct one for my needs?
While the provided data does not specify individual model variations (such as weight capacity, battery life, or folding options), the FEI numbers and registration numbers listed (e.g., 3033905189, 3012604975) indicate regulatory tracking for different distribution or usage scenarios. To determine the best fit, consult the manufacturer’s documentation or sales team, as specifications like load-bearing capacity or maneuverability may vary by configuration. The device is not sterile or single-use, so reuseability is a key factor in selection.
What maintenance or storage requirements should I follow for the Mobility Scooter (BC-MS310) to ensure longevity and safe operation?
As a reusable, non-sterile device, the Mobility Scooter (BC-MS310) requires regular cleaning and maintenance to prevent wear or contamination. Storage should be in a dry, indoor environment to protect against weather damage or moisture, which could affect electrical components. The manufacturer’s instructions (not provided here) should outline specific care protocols, including battery charging, tire pressure checks, and structural inspections. Avoid exposure to extreme temperatures or direct sunlight during storage.
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.
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 | K252817 | Class II | Active |
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Manufacturer
- Manufacturer
- Ningbo Baichen Medical Devices Co., Ltd
- FDA Applicant
- Ningbo Baichen Medical Devices Co., Ltd.
Sources (2)
- FDA 510(k) K252817 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026