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

Bed, Air Fluidized

21 CFR 890.5160 / Physical Medicine
FDA source (opens on fda.gov)

INX is the FDA product code for Bed, Air Fluidized, a class II device type, regulated under 21 CFR 890.5160. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
INX
Device name
Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
28
Ingested recalls
9

Clearances, product code INX

By decision year
28 clearances under product code INX with a decision year between 1976 and 1998, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code INX by decision year
YearClearances
19761
19811
19821
19843
19851
19871
19885
19891
19901
19913
19921
19933
19942
19952
19971
19981

Applicants with the most clearances

Product code INX
Applicants holding the most 510(k) clearances under product code INX
ApplicantClearances
KCI USA, Inc.3
Ssi Medical Services, Inc.3
Air Plus, Inc.1
American Life Support Technology, Inc.1
Anacom General Corporation1
Apollo Fluid Dynamics1
Bemco Mattress Co.1
Cardio Systems, Inc.1
Ch Administration, Inc.1
Dynamedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code