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

Orthosis, Limb Brace

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

IQI is the FDA product code for Orthosis, Limb Brace, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 52 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
IQI
Device name
Orthosis, Limb Brace
Regulation
21 CFR 890.3475
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
52
Ingested recalls
17

Clearances, product code IQI

By decision year
52 clearances under product code IQI with a decision year between 1976 and 2015, 1982 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code IQI by decision year
YearClearances
19762
19774
19784
19796
19809
19818
198210
19833
19871
19911
19931
20031
20061
20151

Applicants with the most clearances

Product code IQI
Applicants holding the most 510(k) clearances under product code IQI
ApplicantClearances
Fred Sammons, Inc.7
Orthomedics5
Conphar, Inc.4
Hosmer Dorrance Corp.3
Aircast, Inc.2
Arco Matic, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
Zimmer GmbH2
3M Company1
Bel-Art Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 508 companies shown, in name order