JAZZY 600— 510(k) K042612

Substantially Equivalent

Pride Mobility Products Corp.

FDA 510(k) clearance K042612 for JAZZY 600, Substantially Equivalent on 2004-10-06. Applicant: Pride Mobility Products Corp..

Clearance details

Applicant: Pride Mobility Products Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2004-09-24
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Exeter, PA, 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.