AOT EXTERNAL COMPRESS DEVICE— 510(k) K854241

Name: FDA 510(k) clearance K854241
Creator: U.S. Food and Drug Administration
Published: 1986-03-03

Substantially Equivalent

Advanced Ortho-Technology, Inc.

FDA 510(k) clearance K854241 for AOT EXTERNAL COMPRESS DEVICE, Substantially Equivalent on 1986-03-03. Applicant: Advanced Ortho-Technology, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Ortho-Technology, Inc.
Product code: Code HWN
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1985-10-21
Decision date: 1986-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuckahoe, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWN

product code HWN

Malfunction: 586
Total: 586

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.