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

Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

21 CFR 890.5290 / Physical Medicine
FDA source (opens on fda.gov)

ILX is the FDA product code for Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a class II device type, regulated under 21 CFR 890.5290. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ILX
Device name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
1

Clearances, product code ILX

By decision year
15 clearances under product code ILX with a decision year between 1989 and 2024, 2009 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ILX by decision year
YearClearances
19891
19911
19971
20021
20071
20081
20092
20101
20121
20132
20191
20201
20241

Applicants with the most clearances

Product code ILX
Applicants holding the most 510(k) clearances under product code ILX
ApplicantClearances
Orthocor Medical Inc.3
Regenesis Biomedical Inc3
Apex Medical, Inc.1
Bioelectronics Corporation1
Caerus Corporation1
Hi-Dow International Inc.1
Ivivi Health Science, LLC1
Ivivi Technologies, Inc.1
Mrt, Inc.1
Paw, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code