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

Adaptor, Hygiene

21 CFR 890.5050 / Physical Medicine
FDA source (opens on fda.gov)

ILS is the FDA product code for Adaptor, Hygiene, a class I device type, regulated under 21 CFR 890.5050. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ILS
Device name
Adaptor, Hygiene
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
31
Ingested recalls
4

Clearances, product code ILS

By decision year
31 clearances under product code ILS with a decision year between 1976 and 1985, 1982 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code ILS by decision year
YearClearances
19765
19782
19794
19801
19814
19828
19835
19841
19851

Applicants with the most clearances

Product code ILS
Applicants holding the most 510(k) clearances under product code ILS
ApplicantClearances
Fred Sammons, Inc.17
Maddak, Inc.3
Guardian Products Co., Inc.2
Lic-Orthion2
Orthion Corp.2
American Stair-Glide Corp.1
Garelick Mfg. Co.1
Kaye Products, Inc.1
Motor Riser Chairs, Ltd.1
Pedro Aleman1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 300 companies shown, in name order