Hero 1, Model LY-ESB220
by Comfort Orthopedic Co., Ltd.
510(k) K031621
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031621 | Date22 Jan 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3900
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a wheelchair, standup, as defined in the device name and openFDA data. It is a motorized mobility device that enables transition between sitting and standing positions, provides seat and backrest recline and lift functions, and facilitates indoor and outdoor mobility.
It is supplied as a motorized standing wheelchair with dual 450W24V motors, dual 50AH12V batteries, a maximum speed of 8.5 km/h, and a maximum loading capacity of 120 kg. The device received FDA 510(k) clearance (K031621) and is classified as a Class II medical device under regulation number 890.3900, with product code IPL, and is authorized for distribution based on its substantial equivalence to a predicate device.
Other devices from Comfort Orthopedic Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What is the HERO 1, Model LY-ESB220 intended for?
The HERO 1, Model LY-ESB220 is a motorized standing wheelchair designed to enable users to transition between sitting and standing positions, provides seat and backrest recline and lift functions, and supports indoor and outdoor mobility for individuals requiring powered mobility assistance.
How is the HERO 1, Model LY-ESB220 supplied and powered?
The device is supplied as a complete motorized standing wheelchair equipped with dual 450W*24V motors and dual 50AH*12V batteries, providing a maximum speed of 8.5 km/h and a maximum loading capacity of 120 kg for user operation.
What regulatory pathway was used for the HERO 1, Model LY-ESB220 to enter the U.S. market?
The HERO 1, Model LY-ESB220 received FDA 510(k) clearance under submission number K031621, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under regulation 890.3900 with product code IPL.