AVACEN 100— 510(k) K133981

Name: FDA 510(k) clearance K133981
Creator: U.S. Food and Drug Administration
Published: 2014-08-15

Substantially Equivalent

Avacen, Inc.

FDA 510(k) clearance K133981 for AVACEN 100, Substantially Equivalent on 2014-08-15. Applicant: Avacen, Inc.. Device class: 2.

Clearance details

Applicant: Avacen, Inc.
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 2013-12-26
Decision date: 2014-08-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.