FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400— 510(k) K992628

Substantially Equivalent

Teftec Corp.

FDA 510(k) clearance K992628 for FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400, Substantially Equivalent on 1999-10-25. Applicant: Teftec Corp..

Clearance details

Applicant: Teftec Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-08-05
Decision date: 1999-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
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.