FDA Product Code IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Leading manufacturers include Chattanooga Group, Inc., Mettler Electronics Corp. and Rich-Mar Corp..
55
Total
55
Cleared
151d
Avg days
1977
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
281d
recently vs 148d historically
FDA 510(k) Cleared Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Devices (Product Code IMG)
55 devices
Cleared
Oct 07, 2025
Ultrasound Therapy Workstation (XMS-UET2)
Xemis Medical Technology (Shenzhen) Co., Ltd.
Physical Medicine
281d
Cleared
Aug 26, 2016
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
Accelerated Care Plus (Acp)
Physical Medicine
256d
Cleared
Nov 13, 2015
BTL-4000
BTL Industries, Inc.
Physical Medicine
275d
Cleared
Nov 13, 2015
ComboRehab
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine
267d
Cleared
Nov 21, 2012
SONICSTIMU COMBO THERAPEUTIC DEVICE
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine
302d
Cleared
Aug 07, 2012
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
Zimmer Medizinsystems GmbH
Physical Medicine
123d
Cleared
Nov 03, 2011
FUTURA
Dr. Oliver Wenker, M.D., M.B.A.
Physical Medicine
427d
Cleared
Aug 25, 2011
SONICATOR PLUS 920
Mettler Electronics Corp.
Physical Medicine
90d
Cleared
Mar 17, 2011
WINSTIM
Johari Digital Healthcare , Ltd.
Physical Medicine
226d
Cleared
Jan 14, 2010
CT2011 SONICSTIMU PAIN RELIEF DEVICE
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine
141d
Cleared
Aug 01, 2007
SONICATOR PLUS 940, MODEL ME940
Mettler Electronics Corp.
Physical Medicine
99d
Cleared
Apr 04, 2007
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
Alfa Tech Medical Systems, Ltd.
Physical Medicine
110d
Cleared
Feb 05, 2007
SONIC-STIM
Naimco, Inc.
Physical Medicine
112d
Cleared
Dec 09, 2005
DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
Alfa Tech Medical Systems, Ltd.
Physical Medicine
105d
Cleared
Apr 12, 2004
VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS)
Chattanooga Group
Physical Medicine
66d
Cleared
Mar 17, 2004
DERMAWAVE 5000 COMBI MAX SYSTEM
Dermawave, LLC
Physical Medicine
57d
Cleared
Dec 11, 2003
VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
Chattanooga Group
Physical Medicine
251d
Cleared
Apr 18, 2003
VECTORSONIC, MODEL VU-270
Metron Medical Australia, Pty, Ltd.
Physical Medicine
29d
Cleared
Feb 14, 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
Reliant Technologies, Inc.
Physical Medicine
154d
Cleared
Jul 22, 2002
VECTORSONIC, MODEL VU-200
Metron Medical Australia, Pty, Ltd.
Physical Medicine
189d
Cleared
Jul 07, 2000
ULTRA V THERAPEUTIC ULTRASOUND
Excel Tech. , Ltd.
Physical Medicine
88d
Cleared
Feb 01, 1999
VECTRA COMBO
Chattanooga Group, Inc.
Physical Medicine
214d
Cleared
Nov 06, 1998
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
Chattanooga Group, Inc.
Physical Medicine
87d
Cleared
Oct 27, 1995
FORTE
Chattanooga Group, Inc.
Physical Medicine
85d
About Product Code IMG - Regulatory Context
510(k) Submission Activity
55 total 510(k) submissions under product code IMG since 1977, with 55 receiving FDA clearance (average review time: 151 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - IMG Product Code
Recent submissions under IMG have taken an average of 281 days to reach a decision - up from 148 days historically. Manufacturers should account for longer review timelines in current project planning.
IMG devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →