IMJ · Class II · 21 CFR 890.5290

FDA Product Code IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Leading manufacturers include Rich-Mar Corp., BTL Industries, Inc. and Henley Intl..

45
Total
45
Cleared
142d
Avg days
1977
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 268d recently vs 133d historically

FDA 510(k) Cleared Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Devices (Product Code IMJ)

45 devices
1–24 of 45
Cleared Jun 12, 2026
BTL-899TT
K252963
BTL Industries, Inc.
Physical Medicine · 268d
Cleared Nov 05, 2025
ViVY
K250376
Viatherm Therapeutics, LLC
Physical Medicine · 268d
Cleared Jun 25, 2025
Curapuls 670
K243112
Enraf-Nonius, B.V.
Physical Medicine · 268d
Cleared May 24, 2023
Reprieve by RegenesisTM
K223620
Regenesis Biomedical, Inc.
Physical Medicine · 170d
Cleared Jan 24, 2019
BTL-703
K182363
BTL Industries, Inc.
Physical Medicine · 147d
Cleared May 01, 2018
ViaTherm BOOST
K173300
Viatherm Therapeutics, LLC
Physical Medicine · 196d
Cleared Nov 17, 2016
ProMedTek Model C1400 Shortwave Diathermy Device
K162240
Promedtek, Inc.
Physical Medicine · 100d
Cleared Nov 14, 2016
ThermoPro
K161862
Zimmer Medizinsysteme GmbH
Physical Medicine · 131d
Cleared Jun 14, 2016
Megapulse III Shortwave Diathermy
K153456
Accelerated Care Plus
Physical Medicine · 196d
Cleared Jul 24, 2014
THERMOPULSE
K131926
Ibramed Equipamentos Medicos
Physical Medicine · 393d
Cleared Mar 14, 2014
SW-THERM
K131899
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 262d
Cleared Mar 10, 2014
BIOFUSIONARY BEBE
K121123
Rocky Mountain Biosystems, Inc.
Physical Medicine · 696d
Cleared Oct 05, 2012
BTL ELITE
K120093
BTL Industries, Inc.
Physical Medicine · 267d
Cleared Mar 18, 2009
INTELECT SWD 100, MODEL 1600
K083433
Chattanooga Group
Physical Medicine · 118d
Cleared Oct 08, 2004
AUTO THERM 390, MODEL ME 390
K042554
Mettler Electronics Corp.
Physical Medicine · 18d
Cleared Sep 26, 2002
AUTO*THERM 395, MODEL ME 395
K022458
Mettler Electronics Corp.
Physical Medicine · 62d
Cleared Jan 23, 1998
MEGAPULSE II
K973732
Pti
Physical Medicine · 115d
Cleared Apr 03, 1997
ULTRATHERM (908)
K964083
Sie-Med, Inc.
Physical Medicine · 174d
Cleared Feb 21, 1997
VASOTHERM
K962243
Ehti Medical Corp.
Physical Medicine · 255d
Cleared Feb 21, 1997
THEE THERMASTIM
K962703
Ehti Medical Corp.
Physical Medicine · 224d
Cleared Dec 29, 1986
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
K864653
Rich-Mar Corp.
Physical Medicine · 31d
Cleared Sep 25, 1986
THE BIO-TEK UW-II
K862932
Bio-Tek Instruments, Inc.
Physical Medicine · 52d
Cleared Aug 01, 1986
ULTRATHERM 808 I
K862589
Elmed, Inc.
Physical Medicine · 25d
Cleared Jul 10, 1986
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
K862468
Rich-Mar Corp.
Physical Medicine · 10d

About Product Code IMJ - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code IMJ since 1977, with 45 receiving FDA clearance (average review time: 142 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IMJ Product Code

Recent submissions under IMJ have taken an average of 268 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

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