Coach 888W
by Wheelchair & Scooter Express 510(k)
Active
510(k) K030760
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030760 | Date10 Jul 2003 | 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- Withdrawn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
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Coach 888W is a powered wheelchair designed to provide mobility for physically challenged users. It functions as a motorized transport device, allowing individuals with limited mobility to navigate their environment.
The device is supplied as a reusable powered wheelchair, classified as a Class II medical device under FDA regulation 890.3860 with product code ITI. It received traditional 510(k) clearance (K030760) on July 10, 2003, as substantially equivalent to a predicate device, and is intended for use in physical medicine settings.
Other devices from Wheelchair & Scooter Express
Questions
AI-generated answers, 25 Sep 2026
What is the COACH 888W intended for?
The COACH 888W is designed to provide mobility for physically challenged users as a motorized transport device, enabling individuals with limited mobility to navigate their environment in physical medicine settings.
Is the COACH 888W reusable or single-use?
The COACH 888W is supplied as a reusable powered wheelchair, meaning it is designed for repeated use over time by the same or different users, not for single-use disposal.
What regulatory pathway was used for the COACH 888W?
The COACH 888W received traditional 510(k) clearance (K030760) on July 10, 2003, demonstrating substantial equivalence to a predicate device under FDA regulation 890.3860 with product code ITI.