VARI-ABLE APB (ADAPTABLE POSITIONING BASE)— 510(k) K042401

Substantially Equivalent

American Track Roadsters, Inc.

FDA 510(k) clearance K042401 for VARI-ABLE APB (ADAPTABLE POSITIONING BASE), Substantially Equivalent on 2004-10-07. Applicant: American Track Roadsters, Inc..

Clearance details

Applicant: American Track Roadsters, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2004-09-03
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, 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.