IMIClass II

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

21 CFR 890.5300 / Physical Medicine

IMI is the FDA product code for Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a class II device type, regulated under 21 CFR 890.5300. As of 2026-09-10, FDA records hold 89 510(k) clearances under this code, the most recent dated 2025-06-04, and 3 recalls.

Classification record

Product code: IMI
Device name: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation: 21 CFR 890.5300
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: Yes
Ingested clearances: 89
Ingested recalls: 3

Clearances, product code IMI

By decision year

89 clearances under product code IMI with a decision year between 1978 and 2025, 2003 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code IMI by decision year
Year	Clearances
1978	1
1980	2
1981	1
1982	2
1984	6
1985	4
1986	1
1987	2
1988	5
1990	2
1991	4
1992	1
1993	5
1995	2
1996	4
1997	2
1998	3
1999	1
2000	5
2001	5
2002	1
2003	7
2004	1
2005	1
2006	3
2007	1
2009	1
2010	1
2011	1
2012	1
2013	1
2014	2
2015	1
2016	3
2017	1
2021	1
2022	1
2023	2
2025	1

Applicants with the most clearances

Product code IMI

Applicants holding the most 510(k) clearances under product code IMI
Applicant	Clearances
Metron Medical Australia, Pty, Ltd.	9
Rich-Mar Corp.	9
Chattanooga Group, Inc.	8
Mettler Electronics Corp	7
General Project S.r.l.	3
Birtcher Corp.	2
Dynatronics Corp.	2
Dynawave, Corp.	2
Henley Intl.	2
Hwang Sun Enterprise Co., Ltd.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order