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

Hand, External Limb Component, Mechanical

21 CFR 890.3420 / Physical Medicine
FDA source (opens on fda.gov)

IRA is the FDA product code for Hand, External Limb Component, Mechanical, a class I device type, regulated under 21 CFR 890.3420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IRA
Device name
Hand, External Limb Component, Mechanical
Regulation
21 CFR 890.3420
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
2
Ingested recalls
0

Clearances, product code IRA

By decision year
2 clearances under product code IRA with a decision year between 1979 and 1982, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IRA by decision year
YearClearances
19791
19821

Applicants with the most clearances

Product code IRA
Applicants holding the most 510(k) clearances under product code IRA
ApplicantClearances
Therapeutic Recreation Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order