510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050524Substantially Equivalent

Ez-IV Medical Pad Warming Unit, Model 1000

Marda Medical, Inc., Jensen Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050524 is the FDA 510(k) clearance record for EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000, a class I device, cleared for Marda Medical, Inc. on under FDA product code IRQ (Unit, Heating, Powered). FDA records list one 510(k) clearance for Marda Medical, Inc. As of , FDA records show no recalls naming K050524.

Clearance record

Decision date
Received
(196 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Marda Medical, Inc. 895 NE Dixie Hwy., Jensen Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IRQ

Trailing 12 months

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

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