Identifiers
- 510(k) Number
- K260717 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 Air Carbon is a motorized three-wheeled vehicle designed for personal mobility assistance. It is classified as a Class II medical device under FDA regulations and intended for individuals with limited mobility to navigate indoor and outdoor environments independently.
This device is supplied as a reusable mobility aid, with no indication of sterility requirements. It is regulated under FDA 510(k) clearance (K260717) and falls under the Physical Medicine specialty category. Multiple registration numbers (e.g., 3033905189) and FEI numbers are associated with its compliance. The device operates under regulation 890.3800 and is intended for use in settings such as homes, public spaces, or healthcare facilities.
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: Sweetrich - Folding Seniors Mobility Motorized Scooters Manufacturers, Suzhou Sweetrich Vehicle Industry Technology Co., Ltd., Mobility Scooter Manufacturer | Globalsweetrich, Mobility Scooter Manufacturer | Sweetrich
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260717 | Class II | Active |
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Manufacturer
- FDA Applicant
- Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Sources (1)
- FDA 510(k) K260717 24 fields · synced Oct 6, 2026