OMEGATRAC, MODEL Z105— 510(k) K013307

Substantially Equivalent

Teftec Corp.

FDA 510(k) clearance K013307 for OMEGATRAC, MODEL Z105, Substantially Equivalent on 2002-02-08. Applicant: Teftec Corp..

Clearance details

Applicant: Teftec Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2001-10-04
Decision date: 2002-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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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.