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

Pad, Heating, Powered

21 CFR 890.5740 / Physical Medicine
FDA source (opens on fda.gov)

IRT is the FDA product code for Pad, Heating, Powered, a class II device type, regulated under 21 CFR 890.5740. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
IRT
Device name
Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
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
42
Ingested recalls
24

Clearances, product code IRT

By decision year
42 clearances under product code IRT with a decision year between 1977 and 2025, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IRT by decision year
YearClearances
19771
19792
19801
19822
19842
19853
19862
19871
19884
19901
19913
19935
19943
19964
19971
20081
20111
20141
20151
20161
20221
20251

Applicants with the most clearances

Product code IRT
Applicants holding the most 510(k) clearances under product code IRT
ApplicantClearances
Conair LLC.7
Sunbeam Health Division2
The Gillette Company2
Mibetec GmbH2
Acurex Aerotherm1
Anthony A. Chiurco1
Arthotronics, Inc.1
Associated Mills, Inc.1
Avacen, Inc.1
Battle Creek Equipment1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 271 companies shown, in name order