RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)— 510(k) K951560

Substantially Equivalent

Radius Intl., Inc.

FDA 510(k) clearance K951560 for RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS), Substantially Equivalent on 1995-04-17. Applicant: Radius Intl., Inc..

Clearance details

Applicant: Radius Intl., Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1995-04-05
Decision date: 1995-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.