Go Go Elite Traveler V Three Wheel Scooter, Model Sc40ev
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090524 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 Go Go Elite Traveler V Three-Wheel Scooter (Model SC40EV) is a motorized three-wheeled mobility vehicle designed for personal transportation. Classified as a motorized three-wheeled vehicle, it is intended to assist individuals with limited mobility in indoor and outdoor environments, providing enhanced independence and maneuverability.
This device is supplied as a reusable, non-sterile product and is intended for use in home, community, and clinical settings. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a classification as a Class II device. The scooter is available in a single model configuration (SC40EV) and requires proper storage to maintain functionality, adhering to manufacturer guidelines for safe operation.
Frequently asked questions
Is the Go Go Elite Traveler V Three-Wheel Scooter (Model SC40EV) intended for single-use or can it be reused?
The Go Go Elite Traveler V Three-Wheel Scooter (Model SC40EV) is explicitly designed as a reusable device. It is not sterile and is meant for long-term use in home, community, and clinical settings, provided it is maintained according to the manufacturer’s guidelines.
What regulatory pathways has the Go Go Elite Traveler V Three-Wheel Scooter (Model SC40EV) followed for approval?
The scooter has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), classified as a Class II device. The FDA clearance was determined under the Special 510(k) review process, with a decision of Substantially Equivalent (SESE) by the Physical Medicine (PM) Advisory Committee.
Are there multiple models or sizes available for the Go Go Elite Traveler V Three-Wheel Scooter?
The Go Go Elite Traveler V Three-Wheel Scooter is available in a single model configuration, the SC40EV. There is no indication of multiple sizes or variants in the provided data.
How should the Go Go Elite Traveler V Three-Wheel Scooter (Model SC40EV) be stored to ensure proper functionality?
The manufacturer provides specific storage guidelines to maintain the scooter’s functionality, though the exact details are not specified in the data. It is recommended to follow the instructions provided by Pride Mobility Products Corp. to ensure safe operation and longevity.
What medical specialty is primarily associated with the use of the Go Go Elite Traveler V Three-Wheel Scooter?
The scooter is primarily associated with the medical specialty of Physical Medicine, as indicated by its classification and the advisory committee involved in its regulatory review. This reflects its intended use for individuals with limited mobility.
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 | K090524 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pride Mobility Products Corp.
Sources (2)
- FDA 510(k) K090524 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026