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

Unit, Heating, Powered

21 CFR 890.5950 / Physical Medicine
FDA source (opens on fda.gov)

IRQ is the FDA product code for Unit, Heating, Powered, a class I device type, regulated under 21 CFR 890.5950. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IRQ
Device name
Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code IRQ

By decision year
7 clearances under product code IRQ with a decision year between 1980 and 2005, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IRQ by decision year
YearClearances
19801
19831
19861
19881
19931
19951
20051

Applicants with the most clearances

Product code IRQ
Applicants holding the most 510(k) clearances under product code IRQ
ApplicantClearances
Ferno1
Fred Sammons, Inc.1
Marda Medical, Inc.1
Thermowave Medical Device Corp.1
Tri W-G, Inc.1
Tru-Eze Mfg. Co., Inc.1
Whitehall/Div Columbus Mckennon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order