CATALYSY— 510(k) K062660

Substantially Equivalent

Ki Mobility, LLC

FDA 510(k) clearance K062660 for CATALYSY, Substantially Equivalent on 2006-10-24. Applicant: Ki Mobility, LLC.

Clearance details

Applicant: Ki Mobility, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2006-09-07
Decision date: 2006-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevens Point, WI, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.