RGK Daily Range Wheelchairs— 510(k) K200135

Substantially Equivalent

Rgk Wheelchairs, Ltd.

FDA 510(k) clearance K200135 for RGK Daily Range Wheelchairs, Substantially Equivalent on 2020-09-10. Applicant: Rgk Wheelchairs, Ltd..

Clearance details

Applicant: Rgk Wheelchairs, Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2020-01-21
Decision date: 2020-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burntwood, GB

Download summary PDF View on FDA.gov ↗

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.