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

Orthosis, Lumbar

21 CFR 890.3490 / Physical Medicine
FDA source (opens on fda.gov)

IQE is the FDA product code for Orthosis, Lumbar, a class I device type, regulated under 21 CFR 890.3490. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IQE
Device name
Orthosis, Lumbar
Regulation
21 CFR 890.3490
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
4
Ingested recalls
0

Clearances, product code IQE

By decision year
4 clearances under product code IQE with a decision year between 1981 and 1982, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IQE by decision year
YearClearances
19812
19822

Applicants with the most clearances

Product code IQE
Applicants holding the most 510(k) clearances under product code IQE
ApplicantClearances
Bandwagon, Inc.1
Fred Sammons, Inc.1
Obus Forme, Ltd.1
Surgical Appliance Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 329 companies shown, in name order