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

Chair, Examination And Treatment

21 CFR 880.6140 / General Hospital
FDA source (opens on fda.gov)

FRK is the FDA product code for Chair, Examination And Treatment, a class I device type, regulated under 21 CFR 880.6140. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FRK
Device name
Chair, Examination And Treatment
Regulation
21 CFR 880.6140
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code FRK

By decision year
4 clearances under product code FRK with a decision year between 1979 and 1989, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FRK by decision year
YearClearances
19793
19891

Applicants with the most clearances

Product code FRK
Applicants holding the most 510(k) clearances under product code FRK
ApplicantClearances
Fem-Gard, Inc.2
American Health Care Industries, Inc.1
JEDMED Instrument Company1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order