IMI · Class II · 21 CFR 890.5300

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

Leading manufacturers include Metron Medical Australia, Pty, Ltd., Rich-Mar Corp. and Mettler Electronics Corp..

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 25, 2017
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
K160378
Brh Medical , Ltd.
Physical Medicine · 562d
Cleared Nov 10, 2016
JAS Pulse(TM) Ultrasonic Therapy
K161628
Bonutti Research, Inc.
Physical Medicine · 150d
Cleared Aug 17, 2016
Accent XL
K160075
Alma Lasers, Inc.
Physical Medicine · 216d
Cleared Aug 16, 2016
MC1 Plus
K161502
General Project S.R.L.
Physical Medicine · 76d
Cleared Aug 26, 2015
UltraTENS
K142976
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 316d
Cleared Jan 27, 2014
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
K131309
Ibramed Equipamentos Medicos
Physical Medicine · 265d
Cleared Jan 09, 2014
SONOPULSE/ SONOPULSE III
K130888
Ibramed- Industria Brazileria DE Equipamentos Medi
Physical Medicine · 286d
Cleared Aug 23, 2013
ACCUSONIC ADVANTAGE
K124010
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 239d
Cleared May 04, 2012
ACCUSONIC ADVANTAGE
K120171
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 105d
Cleared Oct 26, 2011
US-101L, US-103S
K112520
Ito Co., Ltd.
Physical Medicine · 56d
Cleared May 06, 2010
MED CONTOUR
K091615
General Project S.R.L.
Physical Medicine · 337d
Cleared Oct 23, 2009
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
K090542
Sun-Rain System Corp.
Physical Medicine · 235d
Cleared Feb 26, 2007
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
K062256
Hill Laboratories Co.
Physical Medicine · 206d
Cleared Aug 02, 2006
MED SCULPT
K053041
General Project S.R.L.
Physical Medicine · 279d
Cleared Jun 12, 2006
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K052934
S.O.R. Internacional, S.A.
Physical Medicine · 236d
Cleared May 04, 2006
SONICATOR 740, MODEL ME 740
K053546
Mettler Electronics Corp.
Physical Medicine · 135d
Cleared Jul 14, 2005
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
K050410
Hwang Sun Enterprise Co., Ltd.
Physical Medicine · 147d
Cleared Oct 22, 2003
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
K031329
Dynatronics Corp.
Physical Medicine · 177d
Cleared Mar 28, 2003
ACCOUSONIC, MODEL AS-270
K030878
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 8d

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 →