ACTIVX— 510(k) K984367

Substantially Equivalent

Adorno Rogers Technology

FDA 510(k) clearance K984367 for ACTIVX, Substantially Equivalent on 1999-01-28. Applicant: Adorno Rogers Technology.

Clearance details

Applicant: Adorno Rogers Technology
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-12-07
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.