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

Pack, Hot Or Cold, Water Circulating

21 CFR 890.5720 / Physical Medicine
FDA source (opens on fda.gov)

ILO is the FDA product code for Pack, Hot Or Cold, Water Circulating, a class II device type, regulated under 21 CFR 890.5720. As of , FDA records hold 93 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
ILO
Device name
Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
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
93
Ingested recalls
22

Clearances, product code ILO

By decision year
93 clearances under product code ILO with a decision year between 1976 and 2022, 1995 the highest year at 14.
Show the numbers
510(k) clearances under FDA product code ILO by decision year
YearClearances
19764
19771
19781
19791
19801
19834
19841
19851
19872
19883
19897
19905
19918
19923
19934
19948
199514
199612
19977
20041
20072
20081
20091
20221

Applicants with the most clearances

Product code ILO
Applicants holding the most 510(k) clearances under product code ILO
ApplicantClearances
Hollister, Inc.7
Seabrook Medical Systems, Inc.6
Gaymar Industries, Inc.5
Burke Neutech, Inc.4
Thermo Temp, Inc.4
Breg, Inc.3
Breg, Inc.3
Electro-Biology, Inc.3
Temptek, Inc.3
Adroit Medical Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 120 companies shown, in name order