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

Device, Warning, Overload, External Limb, Powered

21 CFR 890.5575 / Physical Medicine
FDA source (opens on fda.gov)

IRN is the FDA product code for Device, Warning, Overload, External Limb, Powered, a class II device type, regulated under 21 CFR 890.5575. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IRN
Device name
Device, Warning, Overload, External Limb, Powered
Regulation
21 CFR 890.5575
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
11
Ingested recalls
0

Clearances, product code IRN

By decision year
11 clearances under product code IRN with a decision year between 1977 and 2006, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IRN by decision year
YearClearances
19771
19791
19881
19952
19963
19991
20021
20061

Applicants with the most clearances

Product code IRN
Applicants holding the most 510(k) clearances under product code IRN
ApplicantClearances
Orthopedic Technology Research, Inc.2
Andante Medical Device, Ltd.1
Andante Medical Devices, Ltd.1
Boulder Impact Monitors, Inc.1
Cleveland Medical Devices, Inc.1
Colmed, Ltd.1
Impact Monitors, Inc.1
Lenjoy Engineering, Inc.1
Orbitec Technologies Corp.1
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code