JAZZY— 510(k) K945936

Substantially Equivalent

Pride Health Care, Inc.

FDA 510(k) clearance K945936 for JAZZY, Substantially Equivalent on 1996-05-28. Applicant: Pride Health Care, Inc..

Clearance details

Applicant: Pride Health Care, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1994-12-05
Decision date: 1996-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Wyoming, 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.