TRAVEL EASE— 510(k) K933406

Substantially Equivalent

Merits Health Products., Inc.

FDA 510(k) clearance K933406 for TRAVEL EASE, Substantially Equivalent on 1993-09-30. Applicant: Merits Health Products., Inc..

Clearance details

Applicant: Merits Health Products., Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1993-07-12
Decision date: 1993-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cape Coral, FL, 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.