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

Electromyograph, Diagnostic

21 CFR 890.1375 / Physical Medicine
FDA source (opens on fda.gov)

IKN is the FDA product code for Electromyograph, Diagnostic, a class II device type, regulated under 21 CFR 890.1375. As of , FDA records hold 75 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IKN
Device name
Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
75
Ingested recalls
1

Clearances, product code IKN

By decision year
75 clearances under product code IKN with a decision year between 1977 and 2017, 2000 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code IKN by decision year
YearClearances
19771
19782
19792
19802
19811
19823
19833
19845
19851
19862
19874
19883
19892
19901
19913
19932
19955
19971
19983
19992
20006
20011
20022
20033
20041
20051
20071
20081
20091
20112
20121
20132
20141
20151
20173

Applicants with the most clearances

Product code IKN
Applicants holding the most 510(k) clearances under product code IKN
ApplicantClearances
Nicolet Biomedical Instruments6
Fasstech3
Teca, Inc.3
Aaron Laboratories, Inc.2
Advantage Medical Division of Cme Telemetrix2
Bio-Logic Systems Corp.2
Cadwell Laboratories, Inc.2
Dorsavi Ltd2
Excel Tech., Ltd.2
Life-Tech Instruments, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order