COMFORT + LIFT— 510(k) K852812

Name: FDA 510(k) clearance K852812
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K852812 for COMFORT + LIFT, Substantially Equivalent on 1985-11-05. Applicant: Invacare Corp.. Device class: 2.

Clearance details

Applicant: Invacare Corp.
Product code: Code INO
Device class: Class 2
Regulation: 21 CFR 890.3110
Advisory panel: Physical Medicine
Date received: 1985-07-02
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

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K062402 — EASYSTAND EVOLV2006-09-21
K061874 — INVACARE'S TWILIGHT II NASAL MASKS2006-09-05
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Adverse events under product code INO

product code INO

Death: 6
Total: 6

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.