510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905113Substantially Equivalent

Roto Rest; Trauma and Intensive Care Bed

Ethos Medical Products, Ltd., Athlone, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905113 is the FDA 510(k) clearance record for ROTO REST; TRAUMA AND INTENSIVE CARE BED, a class II device, cleared for Ethos Medical Products , Ltd. on under FDA product code IKZ (Bed, Patient Rotation, Powered). FDA records list one 510(k) clearance for Ethos Medical Products , Ltd. As of , FDA records show no recalls naming K905113.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IKZ Bed, Patient Rotation, Powered
Regulation
21 CFR 890.5225
Device class
Class II
Review panel
Physical Medicine
Applicant
Ethos Medical Products , Ltd. Monksland Industrial Estate, Athlone, IE
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