DeviceClearance

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.. Device class: 1.

Clearance details

Applicant
American Track Roadsters, Inc.
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lakewood, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IOR

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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, through . 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.