Panels › Physical Medicine › Product code IMJ · Class 2
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Regulation 890.5290
2510(k)s in 12 months (45 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in IMJ
| Company | 510(k)s | Recalls |
|---|---|---|
| BTL Industries, Inc. | 3 | 0 |
| Rich-Mar Corp. | 3 | 0 |
| Ehti Medical Corp. | 2 | 0 |
| Elmed, Inc. | 2 | 0 |
| General Theraphysical, Inc. | 2 | 0 |
| Henley Intl. | 2 | 0 |
| Intl. Medical Electronics , Ltd. | 2 | 0 |
| Mettler Electronics Corp. | 2 | 0 |
| Nemectron Medical, Inc. | 2 | 0 |
| Selicor, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K252963 | BTL-899TT BTL Industries, Inc. | IMJ |
| Nov 5, 2025 | K250376 | ViVY Viatherm Therapeutics, LLC | IMJ |
| Jun 25, 2025 | K243112 | Curapuls 670 Enraf-Nonius, B.V., NL | IMJ |
| May 24, 2023 | K223620 | Reprieve by RegenesisTM Regenesis Biomedical, Inc. | IMJ |
| Jan 24, 2019 | K182363 | BTL-703 BTL Industries, Inc. | IMJ |
| May 1, 2018 | K173300 | ViaTherm BOOST Viatherm Therapeutics, LLC | IMJ |
| Nov 17, 2016 | K162240 | ProMedTek Model C1400 Shortwave Diathermy Device Promedtek, Inc. | IMJ |
| Nov 14, 2016 | K161862 | ThermoPro Zimmer Medizinsysteme GmbH, DE | IMJ |
| Jun 14, 2016 | K153456 | Megapulse III Shortwave Diathermy Accelerated Care Plus | IMJ |
| Jul 24, 2014 | K131926 | THERMOPULSE Ibramed Equipamentos Medicos | IMJ |
| Mar 14, 2014 | K131899 | SW-THERM Shenzhen Dongdixin Technology Co., Ltd., CN | IMJ |
| Mar 10, 2014 | K121123 | BIOFUSIONARY BEBE Rocky Mountain Biosystems, Inc. | IMJ |
| Oct 5, 2012 | K120093 | BTL ELITE BTL Industries, Inc. | IMJ |
| Mar 18, 2009 | K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 Chattanooga Group | IMJ |
| Oct 8, 2004 | K042554 | AUTO THERM 390, MODEL ME 390 Mettler Electronics Corp. | IMJ |
| Apr 1, 2003 | K030382 | SELITHERM, MODEL C100 Selicor, Inc. | IMJ |
| Jan 28, 2003 | K022846 | SW-180 SHORTWAVE THERAPY UNIT Ito Co., Ltd. | IMJ |
| Sep 26, 2002 | K022458 | AUTO*THERM 395, MODEL ME 395 Mettler Electronics Corp. | IMJ |
| Jul 30, 2002 | K020227 | SELICOR, MODELS A100 & D100 Selicor, Inc. | IMJ |
| Jan 23, 1998 | K973732 | MEGAPULSE II Pti | IMJ |
| Apr 3, 1997 | K964083 | ULTRATHERM (908) Sie-Med, Inc. | IMJ |
| Feb 21, 1997 | K962703 | THEE THERMASTIM Ehti Medical Corp. | IMJ |
| Feb 21, 1997 | K962243 | VASOTHERM Ehti Medical Corp. | IMJ |
| Feb 17, 1995 | K934151 | MAGNATHERM MODEL 1000 SS Intl. Medical Electronics , Ltd. | IMJ |
| May 28, 1987 | K871633 | TRU-SOUND ULTRASOUND THERAPY UNIT Tru-Trac Therapy Products, Inc. | IMJ |
| Mar 12, 1987 | K864766 | SOUNDTEK MODEL UT-4700 Soundtek, Inc. | IMJ |
| Dec 29, 1986 | K864653 | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS Rich-Mar Corp. | IMJ |
| Sep 25, 1986 | K862932 | THE BIO-TEK UW-II Bio-Tek Instruments, Inc. | IMJ |
| Aug 1, 1986 | K862589 | ULTRATHERM 808 I Elmed, Inc. | IMJ |
| Jul 23, 1986 | K862376 | NEMECTROSON MODEL 2 Nemectron Medical, Inc. | IMJ |
| Jul 14, 1986 | K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT I-Rep, Inc. | IMJ |
| Jul 10, 1986 | K862469 | RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC Rich-Mar Corp. | IMJ |
| Jul 10, 1986 | K862468 | RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC Rich-Mar Corp. | IMJ |
| May 30, 1986 | K861248 | CURAPULS 419 DIATHERMY UNIT Henley Intl. | IMJ |
| May 30, 1986 | K861247 | CURAMED 402 DIATHERMY UNIT Henley Intl. | IMJ |
| Sep 30, 1985 | K852166 | THERMO SHORTWAVE DIATHERMY Zimmer Elektromedizin GmbH, DE | IMJ |
| May 17, 1985 | K850573 | CURAMED 402 Fluidotherapy Corp. | IMJ |
| Mar 12, 1985 | K844416 | THERMOPULS E Nemectron Medical, Inc. | IMJ |
| Aug 1, 1984 | K842801 | ULTRAMED 11S601 Robert Bosch Corp. | IMJ |
| May 31, 1984 | K841874 | MEGA PULSE THERAPY UNIT Physio Technology, Inc. | IMJ |
| Dec 7, 1978 | K781455 | SIEMENS ULTRATHERM 708 Elmed, Inc. | IMJ |
| Sep 27, 1978 | K781320 | SHORTWAVE THERAPY APPAR. CURAMED 401 General Theraphysical, Inc. | IMJ |
| Sep 27, 1978 | K781316 | PULSED AND CONTINUOUS SHORTWAVE APPAR. General Theraphysical, Inc. | IMJ |
| May 12, 1978 | K780755 | SHORTWAVE DIATHERMY MODEL 802 Birtcher Corp. | IMJ |
| Oct 4, 1977 | K771540 | MAGNATHERM 2000 Intl. Medical Electronics , Ltd. | IMJ |
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