PK-AC POWERED PATIENT MANUPULATING DEVICE— 510(k) K854058

Name: FDA 510(k) clearance K854058
Creator: U.S. Food and Drug Administration
Published: 1986-02-25

Substantially Equivalent

Mannesmann Demag Corp.

FDA 510(k) clearance K854058 for PK-AC POWERED PATIENT MANUPULATING DEVICE, Substantially Equivalent on 1986-02-25. Applicant: Mannesmann Demag Corp.. Device class: 2.

Clearance details

Applicant: Mannesmann Demag Corp.
Product code: Code FNG
Device class: Class 2
Regulation: 21 CFR 880.5500
Advisory panel: General Hospital
Date received: 1985-10-03
Decision date: 1986-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNG

product code FNG

Death: 4
Total: 4

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.