ROLL A BOUT WALKER— 510(k) K941301

Substantially Equivalent

Roll A Bout Corp.

FDA 510(k) clearance K941301 for ROLL A BOUT WALKER, Substantially Equivalent on 1994-05-02. Applicant: Roll A Bout Corp..

Clearance details

Applicant: Roll A Bout Corp.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1994-03-17
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

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.