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

Pack, Heat, Moist

21 CFR 890.5730 / Physical Medicine
FDA source (opens on fda.gov)

IMA is the FDA product code for Pack, Heat, Moist, a class I device type, regulated under 21 CFR 890.5730. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
IMA
Device name
Pack, Heat, Moist
Regulation
21 CFR 890.5730
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
8
Ingested recalls
9

Clearances, product code IMA

By decision year
8 clearances under product code IMA with a decision year between 1979 and 2015, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IMA by decision year
YearClearances
19792
19801
19821
19831
19841
19951
20151

Applicants with the most clearances

Product code IMA
Applicants holding the most 510(k) clearances under product code IMA
ApplicantClearances
Duro-Med Ind., Inc.1
Electro-Med Health Industries, Inc.1
Fred Sammons, Inc.1
Maddak, Inc.1
Rachel'S Remedies, LLC1
Staodynamics, Inc.1
Tru-Eze Mfg. Co., Inc.1
Wahl Clipper Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 86 companies shown, in name order