THE COMFORT LIFT— 510(k) K801796

Name: FDA 510(k) clearance K801796
Creator: U.S. Food and Drug Administration
Published: 1980-08-13

Substantially Equivalent

Gettner Enterprises, Inc.

FDA 510(k) clearance K801796 for THE COMFORT LIFT, Substantially Equivalent on 1980-08-13. Applicant: Gettner Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Gettner Enterprises, Inc.
Product code: Code FMR
Device class: Class 1
Regulation: 21 CFR 880.6785
Advisory panel: General Hospital
Date received: 1980-07-29
Decision date: 1980-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMR

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K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER1987-05-11
K800373 — TENDERLIFT1980-03-12
K792318 — SKIL-CARE TURN AND HOLD PAD1979-12-20
K770499 — PATIENT TURNING AND REPOSITIONING G DEV.1977-04-29

Adverse events under product code FMR

product code FMR

Other: 1
Total: 1

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.