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

Hearing Aid, Tactile

Unknown
FDA source (opens on fda.gov)

LRA is the FDA product code for Hearing Aid, Tactile. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LRA
Device name
Hearing Aid, Tactile
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code LRA

By decision year
8 clearances under product code LRA with a decision year between 1981 and 1988, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LRA by decision year
YearClearances
19811
19832
19841
19852
19861
19881

Applicants with the most clearances

Product code LRA
Applicants holding the most 510(k) clearances under product code LRA
ApplicantClearances
Audiological Engineering Corp.1
Ear Three Systems1
Institute of Logopedics1
Medecon1
Monargue Intl.1
Sevrain-Tech, Inc.1
Sonic Systems, Inc.1
Spectro Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LRA.