Product code IMJ
- Device name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5290
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250376 | ViVY | Viatherm Therapeutics, LLC | 2025-11-05 |
| K243112 | Curapuls 670 | Enraf-Nonius, B.V. | 2025-06-25 |
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical, Inc. | 2023-05-24 |
| K182363 | BTL-703 | BTL Industries, Inc. | 2019-01-24 |
| K173300 | ViaTherm BOOST | Viatherm Therapeutics, LLC | 2018-05-01 |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | 2016-11-17 |
| K161862 | ThermoPro | Zimmer Medizinsysteme GmbH | 2016-11-14 |
| K153456 | Megapulse III Shortwave Diathermy | Accelerated Care Plus | 2016-06-14 |
| K131926 | THERMOPULSE | Ibramed Equipamentos Medicos | 2014-07-24 |
| K131899 | SW-THERM | Shenzhen Dongdixin Technology Co., Ltd. | 2014-03-14 |
| K121123 | BIOFUSIONARY BEBE | Rocky Mountain Biosystems, Inc. | 2014-03-10 |
| K120093 | BTL ELITE | BTL Industries, Inc. | 2012-10-05 |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Chattanooga Group | 2009-03-18 |
| K042554 | AUTO THERM 390, MODEL ME 390 | Mettler Electronics Corp. | 2004-10-08 |
| K030382 | SELITHERM, MODEL C100 | Selicor, Inc. | 2003-04-01 |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Ito Co., Ltd. | 2003-01-28 |
| K022458 | AUTO*THERM 395, MODEL ME 395 | Mettler Electronics Corp. | 2002-09-26 |
| K020227 | SELICOR, MODELS A100 & D100 | Selicor, Inc. | 2002-07-30 |
| K973732 | MEGAPULSE II | Pti | 1998-01-23 |
| K964083 | ULTRATHERM (908) | Sie-Med, Inc. | 1997-04-03 |
| K962243 | VASOTHERM | Ehti Medical Corp. | 1997-02-21 |
| K962703 | THEE THERMASTIM | Ehti Medical Corp. | 1997-02-21 |
| K934151 | MAGNATHERM MODEL 1000 SS | Intl. Medical Electronics , Ltd. | 1995-02-17 |
| K871633 | TRU-SOUND ULTRASOUND THERAPY UNIT | Tru-Trac Therapy Products, Inc. | 1987-05-28 |
| K864766 | SOUNDTEK MODEL UT-4700 | Soundtek, Inc. | 1987-03-12 |
| K864653 | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS | Rich-Mar Corp. | 1986-12-29 |
| K862932 | THE BIO-TEK UW-II | Bio-Tek Instruments, Inc. | 1986-09-25 |
| K862589 | ULTRATHERM 808 I | Elmed, Inc. | 1986-08-01 |
| K862376 | NEMECTROSON MODEL 2 | Nemectron Medical, Inc. | 1986-07-23 |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | I-Rep, Inc. | 1986-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720618311177 | Curapuls 670 | Enraf-Nonius B.V. | 2025-09-23 |
| 00868924000038 | Reprieve by Regenesis | Regenesis Biomedical, Inc. | 2023-08-23 |
| 00850886008016 | Replexa+ Treatment Applicator | PROMEDTEK, INC. | 2019-07-08 |
| 00850886008009 | Replexa+ Device | PROMEDTEK, INC. | 2019-07-08 |
| B108703POENUS0100 | BTL-703 | BTL INDUSTRIES LIMITED | 2019-04-16 |
| 00092237620397 | Richmar TheraTouch | Drive Devilbiss Healthcare | 2019-02-08 |
| 04053815055174 | ThermoPro | Zimmer MedizinSysteme GmbH | 2016-12-16 |
| 00816864020531 | Drum Applicator 3980 | METTLER ELECTRONICS CORP. | 2016-09-15 |
| 00816864020180 | Auto*Therm 390 | METTLER ELECTRONICS CORP. | 2016-09-15 |
| 00888912335645 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912253949 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912188685 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912188050 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912187916 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912187909 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912187855 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912187848 | CHATTANOOGA | DJO, LLC | 2016-09-15 |
| 00888912253772 | CHATTANOOGA | DJO, LLC | 2016-09-12 |
| 00888912187831 | CHATTANOOGA | DJO, LLC | 2016-09-12 |
| 00858703006078 | Megapulse II | ACCELERATED CARE PLUS CORP | 2016-08-16 |
| 00858703006085 | Megapulse III/OmniSWD | ACCELERATED CARE PLUS CORP | 2016-08-16 |