Comfort Dreamrider Scooter LY-EW402
by Comfort Orthopedic Co., Ltd.
510(k) K021910
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021910 | Date11 Oct 2002 | 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- Withdrawn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
- 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
A motorized three-wheeled vehicle designed to provide mobility for individuals restricted to a seated position. It is operated by the user via manual controls and functions as a personal mobility aid.
The device is supplied as a reusable mobility scooter for use in personal or institutional settings. It has received FDA 510(k) clearance under product code INI and regulation number 890.3800, with a classification as a Class II device.
Other devices from Comfort Orthopedic Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the COMFORT DREAMRIDER SCOOTER LY-EW402 intended for?
It is designed to provide mobility for individuals restricted to a seated position, allowing them to move independently in personal or institutional settings using manual controls as a personal mobility aid.
Is the COMFORT DREAMRIDER SCOOTER LY-EW402 reusable or single-use?
The device is supplied as a reusable mobility scooter, meaning it is intended for repeated use over time in personal or institutional environments, not for single-patient disposal.
How was the COMFORT DREAMRIDER SCOOTER LY-EW402 cleared for market?
It received FDA 510(k) clearance under submission number K021910, demonstrating substantial equivalence to a legally marketed predicate device under product code INI and regulation 890.3800, classified as a Class II device.