SCC22/ SCC26 SHOWER COMMODE CHAIR— 510(k) K943293

Substantially Equivalent

O'Tec Corp.

FDA 510(k) clearance K943293 for SCC22/ SCC26 SHOWER COMMODE CHAIR, Substantially Equivalent on 1994-08-19. Applicant: O'Tec Corp..

Clearance details

Applicant: O'Tec Corp.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1994-07-08
Decision date: 1994-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellis, KS, 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.