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., Rich-Mar Corp. and Excel Tech. , Ltd..

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 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 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 Jun 20, 1994
FORTE US
K941561
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Apr 15, 1994
FORTE US
K940180
Chattanooga Group, Inc.
Physical Medicine · 93d
Cleared Feb 02, 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271
Chattanooga Group, Inc.
Physical Medicine · 92d
Cleared Jun 29, 1993
SONOPULS 591
K922036
Henley Intl.
Physical Medicine · 424d
Cleared Mar 09, 1993
ULTRA III
K921952
Excel Tech. , Ltd.
Physical Medicine · 316d
Cleared Nov 06, 1992
MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED
K923797
Rich-Mar Corp.
Physical Medicine · 101d
Cleared Dec 17, 1991
INTELECT, MODEL 245
K911733
Chattanooga Group, Inc.
Physical Medicine · 244d
Cleared Sep 27, 1990
INTELECT 170
K902860
Chattanooga Group, Inc.
Physical Medicine · 90d
Cleared Sep 27, 1990
INTELECT 750 MP
K902875
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Sep 18, 1990
CURAPULS 403 DIATHERMY UNIT
K900189
Henley Intl.
Physical Medicine · 245d
Cleared Feb 20, 1990
ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
K895690
Excel Tech. , Ltd.
Physical Medicine · 151d
Cleared Sep 03, 1987
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394
Henley Intl.
Physical Medicine · 83d
Cleared Nov 27, 1984
RICH-MAR DELTA 330 HV
K844217
Rich-Mar Corp.
Physical Medicine · 27d
Cleared Feb 22, 1982
INTELECT MODEL 700
K813594
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Apr 03, 1981
RICH-MAR HV II SELECT-A-PULSE
K810526
Rich-Mar Corp.
Physical Medicine · 36d
Cleared Jan 13, 1978
MUSCLE STIMULATOR
K772287
Rich-Mar Corp.
Radiology · 32d

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 →