Travel Ease Electric Scooter, Model Pioneer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K952042 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 Travel Ease Electric Scooter, Model Pioneer, is a motorized three-wheeled vehicle classified as a mobility aid. Designed for adults with limited physical mobility, it provides assisted transportation through electric propulsion, enabling independent movement in indoor and outdoor environments. Its three-wheeled configuration enhances stability and maneuverability for users requiring enhanced mobility support.
This device is supplied as a reusable, non-sterile mobility aid intended for home or clinical use. It is regulated under FDA 510(k) clearance (K952042) and falls under the Physical Medicine specialty category. The scooter operates via user-controlled mechanisms and is not intended for MRI environments. Storage and maintenance instructions are provided by the manufacturer to ensure proper functionality and longevity.
Frequently asked questions
What is the Travel Ease Pioneer electric scooter designed for?
The Travel Ease Pioneer electric scooter is designed as a motorized mobility aid for adults with limited physical mobility. Its three-wheeled configuration enhances stability and maneuverability, enabling independent movement in both indoor and outdoor environments. This makes it suitable for users who require assisted transportation but may struggle with traditional wheelchairs or walking aids.
Is the Travel Ease Pioneer scooter reusable or single-use?
The Travel Ease Pioneer scooter is supplied as a reusable device. It is not intended for single-use and is meant to be used repeatedly by individuals or in clinical settings, provided it is maintained according to the manufacturer’s instructions. Reusability extends its utility for long-term mobility support.
What type of sterility does the Travel Ease Pioneer scooter have?
The Travel Ease Pioneer scooter is classified as a non-sterile device. It is intended for home or clinical use where sterility is not a critical requirement, such as general mobility assistance. Sterility is not applicable in this context, as the device is designed for functional use rather than invasive or sterile procedures.
Can the Travel Ease Pioneer scooter be used in an MRI environment?
No, the Travel Ease Pioneer scooter is not intended for use in MRI environments. The device contains materials and components that could interfere with MRI imaging or pose safety risks in such settings. Users should avoid bringing the scooter near MRI machines unless explicitly approved by the MRI facility.
How is the Travel Ease Pioneer scooter regulated and approved?
The Travel Ease Pioneer scooter is regulated under the FDA’s 510(k) clearance process, with a clearance number of K952042. It falls under the Physical Medicine specialty category and is classified as a Class II device. The device was determined to be substantially equivalent to legally marketed predecessors, ensuring it meets safety and performance standards for motorized three-wheeled mobility aids.
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: TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER (K952042) — FDA 510 (k ..., TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER by MERITS HEALTH PRODUCTS ..., Travel Ease Electric Scooter, Model: Pioneer 510 (k) FDA Premarket ..., Travel Ease Electric Scooter, Model Pioneer 5, PDF K952042 Travel Ease Electric Scooter, Model: Pioneer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K952042 | Class II | Active |
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Manufacturer
- Manufacturer
- Merits Health Products Co., Ltd.
Sources (1)
- FDA 510(k) K952042 24 fields · synced Oct 1, 2026