MR4500 WHEELCHAIR— 510(k) K120391

Substantially Equivalent

Wardray Premise, Ltd.

FDA 510(k) clearance K120391 for MR4500 WHEELCHAIR, Substantially Equivalent on 2012-12-21. Applicant: Wardray Premise, Ltd..

Clearance details

Applicant: Wardray Premise, Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2012-02-07
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NH, 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.