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

Cabinet, Moist Steam

21 CFR 890.5250 / Physical Medicine
FDA source (opens on fda.gov)

IMB is the FDA product code for Cabinet, Moist Steam, a class II device type, regulated under 21 CFR 890.5250. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
IMB
Device name
Cabinet, Moist Steam
Regulation
21 CFR 890.5250
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
5
Ingested recalls
5

Clearances, product code IMB

By decision year
5 clearances under product code IMB with a decision year between 1977 and 2002, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IMB by decision year
YearClearances
19771
19811
19921
19971
20021

Applicants with the most clearances

Product code IMB
Applicants holding the most 510(k) clearances under product code IMB
ApplicantClearances
Health Improvement Assoc.1
Sauna Magic, Inc.1
Scandia Manufacturing, Ltd.1
Shinsei Corp.1
Thermia, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code