COACH 888W— 510(k) K030760

Substantially Equivalent

Wheelchair & Scooter Express

FDA 510(k) clearance K030760 for COACH 888W, Substantially Equivalent on 2003-07-10. Applicant: Wheelchair & Scooter Express.

Clearance details

Applicant: Wheelchair & Scooter Express
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2003-03-11
Decision date: 2003-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.