INVACARE EXTENDED CARE NURSING HOME BED— 510(k) K900151

Name: FDA 510(k) clearance K900151
Creator: U.S. Food and Drug Administration
Published: 1990-06-18

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K900151 for INVACARE EXTENDED CARE NURSING HOME BED, Substantially Equivalent on 1990-06-18. Applicant: Invacare Corp.. Device class: 2.

Clearance details

Applicant: Invacare Corp.
Product code: Code FNL
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 1990-01-11
Decision date: 1990-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

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K974254 — BENEFIT B3--- SERIES1997-12-16

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K071928 — THE INVACARE FLYER, MODEL IPC 1002007-12-12
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K062402 — EASYSTAND EVOLV2006-09-21
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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.