Mega 3 Motorized 3-Wheeled Vehicle
510(k) K982145
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982145 | Date14 Apr 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Mega 3
- 510(k) Number
- FDA Product Code
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mega 3 is a motorized three-wheeled vehicle designed for mobility assistance, classified as a vehicle under FDA nomenclature. It is intended to provide users with powered movement, supporting physical medicine applications in clinical or home settings. The device features a three-wheeled configuration for stability and maneuverability, tailored for individuals requiring enhanced mobility solutions.
This device is supplied as a reusable, non-sterile product, with no specific MRI safety restrictions noted in the data. It is regulated under FDA 510(k) clearance (K982145) and falls under Class II medical devices. Multiple registration numbers and FEI numbers are associated with its submission, indicating compliance with regulatory requirements for physical medicine applications. Storage and maintenance instructions are not specified in the provided data.
Other devices from Mega Motion, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Mega 3 motorized vehicle designed for?
The Mega 3 is a motorized three-wheeled vehicle intended for mobility assistance. It supports physical medicine applications in both clinical and home settings, providing users with powered movement for enhanced stability and maneuverability. Its three-wheeled design is specifically tailored to improve accessibility and independence for individuals requiring mobility solutions.
Is the Mega 3 a single-use or reusable device?
The Mega 3 is supplied as a reusable device. Unlike single-use products, it is intended for repeated use by multiple individuals or over extended periods, provided it is properly maintained and cleaned according to manufacturer guidelines. The reusable nature makes it cost-effective for long-term mobility support in both clinical and home environments.
What are the sterility and MRI safety considerations for the Mega 3?
The Mega 3 is classified as a non-sterile device, meaning it does not require sterile packaging or handling for its intended use. Additionally, there are no specific MRI safety restrictions noted for this device, allowing users to operate it in environments where MRI compatibility may be a concern. However, it is always recommended to consult the manufacturer’s instructions for any potential electromagnetic interference or safety precautions.
How is the Mega 3 regulated and approved?
The Mega 3 is regulated under the FDA’s 510(k) clearance process and falls under Class II medical devices. It received FDA clearance (K982145) in 1999, with a decision confirming it is substantially equivalent to legally marketed devices. The device is also associated with multiple registration numbers and FEI numbers, indicating compliance with regulatory requirements for physical medicine applications. For detailed regulatory documentation, refer to the FDA’s OpenFDA database.
Are there different models or sizes available for the Mega 3?
The provided data does not specify variations in sizes or distinct model numbers beyond the Mega 3 designation itself. However, the device is categorized under motorized three-wheeled vehicles, which may imply potential customization options for specific user needs. For precise sizing or model-specific inquiries, it is best to consult Mega Motion, Inc. directly, as they may offer tailored configurations based on individual requirements.