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

System, Environmental Control, Powered

21 CFR 890.3725 / Physical Medicine
FDA source (opens on fda.gov)

IQA is the FDA product code for System, Environmental Control, Powered, a class II device type, regulated under 21 CFR 890.3725. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
IQA
Device name
System, Environmental Control, Powered
Regulation
21 CFR 890.3725
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
24
Ingested recalls
17

Clearances, product code IQA

By decision year
24 clearances under product code IQA with a decision year between 1977 and 1996, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code IQA by decision year
YearClearances
19771
19831
19841
19853
19873
19881
19891
19903
19911
19921
19931
19942
19954
19961

Applicants with the most clearances

Product code IQA
Applicants holding the most 510(k) clearances under product code IQA
ApplicantClearances
Prentke Romich Co.3
Rehab Technology, Inc.3
Apt Technology, Inc.2
Baylor Biomedical Services2
J. H. Emerson Co.2
Hill-Rom Inc.1
Independent Living, Inc.1
Interactive Technologies, Inc.1
Intl. Management Services, Inc.1
Possum, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order