OMEGA TRAC, MODEL Z100— 510(k) K993160

Substantially Equivalent

Teftec Corp.

FDA 510(k) clearance K993160 for OMEGA TRAC, MODEL Z100, Substantially Equivalent on 1999-11-18. Applicant: Teftec Corp..

Clearance details

Applicant: Teftec Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-09-21
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Spring Branch, 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.