510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K950681Substantially Equivalent

Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950681 is the FDA 510(k) clearance record for MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY, a class II device, cleared for Invacare Corp. on under FDA product code IKZ (Bed, Patient Rotation, Powered). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K950681.

Clearance record

Decision date
Received
(91 days to decision)
Product code
IKZ Bed, Patient Rotation, Powered
Regulation
21 CFR 890.5225
Device class
Class II
Review panel
Physical Medicine
Applicant
Invacare Corp. 899 Cleveland St., Elyria OH
510(k) summary
Summary
Third party review
No

Clearances, product code IKZ

Trailing 12 months

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

FDA records show no clearances under product code IKZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKZ, 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