IMI · Class II · 21 CFR 890.5300

FDA Product Code IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Leading manufacturers include Rich-Mar Corp., Mettler Electronics Corp. and Chattanooga Group, Inc..

89
Total
89
Cleared
156d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 439d recently vs 153d historically

FDA 510(k) Cleared Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Devices (Product Code IMI)

89 devices
1–24 of 89
Cleared Jun 04, 2025
Ultrasound Stimulator
K240788
Jkh Health Co., Ltd.
Physical Medicine · 439d
Cleared Oct 24, 2023
Sonopuls 190
K230472
Enraf-Nonius, B.V.
Physical Medicine · 244d
Cleared Mar 08, 2023
ManaSport+
K222098
Manamed, Inc.
Physical Medicine · 233d
Cleared Apr 26, 2022
ManaSport
K210284
Manamed, Inc.
Physical Medicine · 448d
Cleared Dec 23, 2021
Sonomed IV, Sonomed V
K202788
Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
Physical Medicine · 457d
Cleared Aug 26, 2015
UltraTENS
K142976
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 316d
Cleared May 04, 2006
SONICATOR 740, MODEL ME 740
K053546
Mettler Electronics Corp.
Physical Medicine · 135d
Cleared Sep 13, 2002
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483
Rich-Mar Corp.
Physical Medicine · 128d
Cleared Oct 17, 2001
SONICATOR PLUS 930, MODEL ME 930
K013192
Mettler Electronics Corp.
Physical Medicine · 22d
Cleared Nov 19, 1998
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K982544
Rich-Mar Corp.
Physical Medicine · 121d
Cleared Nov 06, 1998
FORTE, MODEL CPS ULTRASOUND
K982829
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Nov 10, 1997
INTELECT LEGEND ULTRASOUND
K973024
Chattanooga Group, Inc.
Physical Medicine · 88d
Cleared May 15, 1995
RICH-MAR US-II ULTRASOUND
K950564
Rich-Mar Corp.
Physical Medicine · 96d
Cleared Jul 02, 1993
INTELECT 222 P
K930307
Chattanooga Group, Inc.
Physical Medicine · 162d
Cleared Mar 09, 1993
SONOPULS 590
K920983
Henley Intl.
Physical Medicine · 372d
Cleared Mar 09, 1993
ULTRA SX
K923076
Excel Tech. , Ltd.
Physical Medicine · 257d
Cleared Mar 10, 1992
RICH-MAR MODEL 510 ULTRASOUND
K915557
Rich-Mar Corp.
Physical Medicine · 90d
Cleared Nov 13, 1991
RICH-MAR MODEL II ULTRASOUND
K913981
Rich-Mar Corp.
Physical Medicine · 68d
Cleared Sep 17, 1991
RICH-MAR MODEL 25 ULTRASOUND
K912202
Rich-Mar Corp.
Physical Medicine · 120d
Cleared May 21, 1991
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708
Rich-Mar Corp.
Physical Medicine · 90d
Cleared Jan 14, 1991
RICH-MAR MODEL V ULTRASOUND
K904051
Rich-Mar Corp.
Physical Medicine · 132d
Cleared Aug 18, 1988
SONICATOR 720 (MODEL ME720)
K883228
Mettler Electronics Corp.
Physical Medicine · 17d
Cleared Mar 17, 1988
SONICATOR 710 (MODEL ME710)
K880901
Mettler Electronics Corp.
Physical Medicine · 15d
Cleared Feb 25, 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602
Mettler Electronics Corp.
Physical Medicine · 14d

About Product Code IMI - Regulatory Context

510(k) Submission Activity

89 total 510(k) submissions under product code IMI since 1978, with 89 receiving FDA clearance (average review time: 156 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - IMI Product Code

Recent submissions under IMI have taken an average of 439 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.

IMI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →