510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924023Substantially Equivalent

Ferno Ille Inferno Moist Heat Therapy Ut, 916/917

Ferno, Wilmington OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924023 is the FDA 510(k) clearance record for FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917, a class I device, cleared for Ferno on under FDA product code IRQ (Unit, Heating, Powered). FDA records list 5 510(k) clearances for Ferno, from to . As of , FDA records show no recalls naming K924023.

Clearance record

Decision date
Received
(246 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Ferno 70 Weil Way, Wilmington OH
510(k) summary
Statement
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