Golden Liteway
by Golden Technologies, Inc. 510(k)
Active
510(k) K063162
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063162 | Date2 Nov 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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 Golden Liteway is a motorized three-wheeled vehicle designed for mobility assistance, classified as a vehicle under FDA’s nomenclature. It is intended to provide users with powered transportation, enhancing independence for individuals with limited mobility. This device operates as a mobility scooter, offering adjustable seating and maneuverability for indoor and outdoor use.
The Golden Liteway is supplied as a reusable, non-sterile medical device and is classified under FDA’s Class II regulatory category. It is intended for use in home, clinical, or community settings and requires no special storage conditions beyond those recommended by the manufacturer. The device holds an FDA 510(k) clearance (K063162) under the Special review pathway for Physical Medicine applications, ensuring compliance with regulatory standards for motorized mobility aids.
Other devices from Golden Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Golden Liteway used for?
The Golden Liteway is a motorized three-wheeled vehicle designed to assist individuals with limited mobility. It provides powered transportation, enabling greater independence for users in both indoor and outdoor environments. The adjustable seating and maneuverability make it suitable for home, clinical, or community use.
Is the Golden Liteway reusable or single-use?
The Golden Liteway is supplied as a reusable medical device. It is not intended for single-use and is designed to be used repeatedly by authorized users, provided it is maintained according to the manufacturer’s guidelines.
What are the storage requirements for the Golden Liteway?
The Golden Liteway does not require special storage conditions beyond those recommended by Golden Technologies, Inc. Standard care, such as keeping it in a dry environment and following manufacturer instructions, ensures optimal performance and longevity.
Is the Golden Liteway sterile?
No, the Golden Liteway is classified as a non-sterile medical device. It is intended for use in environments where sterility is not a primary concern, such as home or community settings, and is designed for durability and repeated use.
What regulatory pathway does the Golden Liteway follow?
The Golden Liteway holds an FDA 510(k) clearance (K063162) under the Special review pathway for Physical Medicine applications. This classification confirms it meets regulatory standards for motorized mobility aids and is substantially equivalent to a predicate device.