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

Goniometer, Ac-Powered

21 CFR 888.1500 / Orthopedic
FDA source (opens on fda.gov)

KQX is the FDA product code for Goniometer, Ac-Powered, a class I device type, regulated under 21 CFR 888.1500. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KQX
Device name
Goniometer, Ac-Powered
Regulation
21 CFR 888.1500
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
33
Ingested recalls
0

Clearances, product code KQX

By decision year
33 clearances under product code KQX with a decision year between 1981 and 2001, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KQX by decision year
YearClearances
19812
19831
19841
19851
19861
19871
19881
19894
19902
19914
19923
19931
19944
19953
19962
19971
20011

Applicants with the most clearances

Product code KQX
Applicants holding the most 510(k) clearances under product code KQX
ApplicantClearances
Nk Biotechnical Engineering Co.3
Mizuho Orthopedic Systems Inc3
Greenleaf Medical Systems, Inc.2
J-Tech, Inc.2
Andronic Devices, Ltd.1
Baltimore Therapeutic Equipment Co.1
Cairco, Ltd.1
Chattanooga Group, Inc.1
Cybex1
Digital Body Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order