Cleared Traditional

THE COMFORT LIFT (K801796) - FDA 510(k) Clearance

Class I General Hospital device.

K801796 · Gettner Enterprises, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
15d
Days
Class 1
Risk

K801796 is an FDA 510(k) clearance for the THE COMFORT LIFT. Classified as Device, Transfer, Patient, Manual (product code FMR), Class I - General Controls.

Submitted by Gettner Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6785 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gettner Enterprises, Inc. devices

Submission Details

510(k) Number K801796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date August 13, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMR Device, Transfer, Patient, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6785
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.