IMG · Class II · 21 CFR 890.5860

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
1–24 of 55
Cleared Oct 07, 2025
Ultrasound Therapy Workstation (XMS-UET2)
K244041
Xemis Medical Technology (Shenzhen) Co., Ltd.
Physical Medicine · 281d
Cleared Aug 26, 2016
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
K153559
Accelerated Care Plus (Acp)
Physical Medicine · 256d
Cleared Nov 13, 2015
BTL-4000
K150353
BTL Industries, Inc.
Physical Medicine · 275d
Cleared Nov 13, 2015
ComboRehab
K150436
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 267d
Cleared Nov 21, 2012
SONICSTIMU COMBO THERAPEUTIC DEVICE
K120217
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 302d
Cleared Aug 07, 2012
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
K121059
Zimmer Medizinsystems GmbH
Physical Medicine · 123d
Cleared Aug 25, 2011
SONICATOR PLUS 920
K111482
Mettler Electronics Corp.
Physical Medicine · 90d
Cleared Jan 14, 2010
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 141d
Cleared Aug 01, 2007
SONICATOR PLUS 940, MODEL ME940
K071137
Mettler Electronics Corp.
Physical Medicine · 99d
Cleared Apr 18, 2003
VECTORSONIC, MODEL VU-270
K030880
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
K023050
Reliant Technologies, Inc.
Physical Medicine · 154d
Cleared Jul 22, 2002
VECTORSONIC, MODEL VU-200
K020119
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 189d
Cleared Jul 07, 2000
ULTRA V THERAPEUTIC ULTRASOUND
K001166
Excel Tech. , Ltd.
Physical Medicine · 88d
Cleared Feb 01, 1999
VECTRA COMBO
K982317
Chattanooga Group, Inc.
Physical Medicine · 214d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K982830
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Oct 27, 1995
FORTE
K953614
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared Jun 21, 1995
FORTE CB
K951746
Chattanooga Group, Inc.
Physical Medicine · 97d
Cleared Aug 29, 1994
SONICATOR 730
K943469
Mettler Electronics Corp.
Physical Medicine · 41d
Cleared Jun 20, 1994
FORTE US
K941561
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Apr 26, 1994
DYNATRON 150
K935728
Dynatronics Corp.
Physical Medicine · 146d
Cleared Apr 15, 1994
FORTE US
K940180
Chattanooga Group, Inc.
Physical Medicine · 93d
Cleared Mar 23, 1994
SONICATOR 716
K934846
Mettler Electronics Corp.
Physical Medicine · 166d
Cleared Feb 02, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271
Chattanooga Group, Inc.
Physical Medicine · 92d
Cleared Jan 21, 1994
SONICATOR 715
K934845
Mettler Electronics Corp.
Physical Medicine · 105d

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 →