510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801796Substantially Equivalent

The Comfort Lift

Gettner Enterprises, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801796 is the FDA 510(k) clearance record for THE COMFORT LIFT, a class I device, cleared for Gettner Enterprises, Inc. on under FDA product code FMR (Device, Transfer, Patient, Manual). FDA records list one 510(k) clearance for Gettner Enterprises, Inc. As of , FDA records show no recalls naming K801796.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FMR Device, Transfer, Patient, Manual
Regulation
21 CFR 880.6785
Device class
Class I
Review panel
General Hospital
Applicant
Gettner Enterprises, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMR

Trailing 12 months

FDA records hold no clearances under product code FMR in the trailing twelve months.

FDA records show no clearances under product code FMR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260