FDA Product Code
FDA Product Code IMJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5290
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252963 | BTL-899TT | BTL Industries, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K250376 | ViVY | Viatherm Therapeutics, LLC | 2025-11-05 | Traditional | PDF ↗ |
| K243112 | Curapuls 670 | Enraf-Nonius, B.V. | 2025-06-25 | Traditional | PDF ↗ |
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical, Inc. | 2023-05-24 | Traditional | PDF ↗ |
| K182363 | BTL-703 | BTL Industries, Inc. | 2019-01-24 | Traditional | PDF ↗ |
| K173300 | ViaTherm BOOST | Viatherm Therapeutics, LLC | 2018-05-01 | Traditional | PDF ↗ |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Promedtek, Inc. | 2016-11-17 | Traditional | PDF ↗ |
| K161862 | ThermoPro | Zimmer Medizinsysteme GmbH | 2016-11-14 | Traditional | PDF ↗ |
| K153456 | Megapulse III Shortwave Diathermy | Accelerated Care Plus | 2016-06-14 | Traditional | PDF ↗ |
| K131926 | THERMOPULSE | Ibramed Equipamentos Medicos | 2014-07-24 | Traditional | PDF ↗ |
| K131899 | SW-THERM | Shenzhen Dongdixin Technology Co., Ltd. | 2014-03-14 | Traditional | PDF ↗ |
| K121123 | BIOFUSIONARY BEBE | Rocky Mountain Biosystems, Inc. | 2014-03-10 | Traditional | PDF ↗ |
| K120093 | BTL ELITE | BTL Industries, Inc. | 2012-10-05 | Traditional | PDF ↗ |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Chattanooga Group | 2009-03-18 | Traditional | PDF ↗ |
| K042554 | AUTO THERM 390, MODEL ME 390 | Mettler Electronics Corp. | 2004-10-08 | Abbreviated | PDF ↗ |
| K030382 | SELITHERM, MODEL C100 | Selicor, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Ito Co., Ltd. | 2003-01-28 | Traditional | PDF ↗ |
| K022458 | AUTO*THERM 395, MODEL ME 395 | Mettler Electronics Corp. | 2002-09-26 | Abbreviated | PDF ↗ |
| K020227 | SELICOR, MODELS A100 & D100 | Selicor, Inc. | 2002-07-30 | Traditional | PDF ↗ |
| K973732 | MEGAPULSE II | Pti | 1998-01-23 | Traditional | PDF ↗ |
| K964083 | ULTRATHERM (908) | Sie-Med, Inc. | 1997-04-03 | Traditional | PDF ↗ |
| K962703 | THEE THERMASTIM | Ehti Medical Corp. | 1997-02-21 | Traditional | PDF ↗ |
| K962243 | VASOTHERM | Ehti Medical Corp. | 1997-02-21 | Traditional | PDF ↗ |
| K934151 | MAGNATHERM MODEL 1000 SS | Intl. Medical Electronics , Ltd. | 1995-02-17 | Traditional | PDF ↗ |
| K871633 | TRU-SOUND ULTRASOUND THERAPY UNIT | Tru-Trac Therapy Products, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K864766 | SOUNDTEK MODEL UT-4700 | Soundtek, Inc. | 1987-03-12 | Traditional | PDF ↗ |
| K864653 | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS | Rich-Mar Corp. | 1986-12-29 | Traditional | PDF ↗ |
| K862932 | THE BIO-TEK UW-II | Bio-Tek Instruments, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K862589 | ULTRATHERM 808 I | Elmed, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K862376 | NEMECTROSON MODEL 2 | Nemectron Medical, Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | I-Rep, Inc. | 1986-07-14 | Traditional | PDF ↗ |
| K862468 | RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC | Rich-Mar Corp. | 1986-07-10 | Traditional | PDF ↗ |
| K862469 | RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC | Rich-Mar Corp. | 1986-07-10 | Traditional | PDF ↗ |
| K861247 | CURAMED 402 DIATHERMY UNIT | Henley Intl. | 1986-05-30 | Traditional | PDF ↗ |
| K861248 | CURAPULS 419 DIATHERMY UNIT | Henley Intl. | 1986-05-30 | Traditional | PDF ↗ |
| K852166 | THERMO SHORTWAVE DIATHERMY | Zimmer Elektromedizin GmbH | 1985-09-30 | Traditional | PDF ↗ |
| K850573 | CURAMED 402 | Fluidotherapy Corp. | 1985-05-17 | Traditional | PDF ↗ |
| K844416 | THERMOPULS E | Nemectron Medical, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K842801 | ULTRAMED 11S601 | Robert Bosch Corp. | 1984-08-01 | Traditional | PDF ↗ |
| K841874 | MEGA PULSE THERAPY UNIT | Physio Technology, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K781455 | SIEMENS ULTRATHERM 708 | Elmed, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K781316 | PULSED AND CONTINUOUS SHORTWAVE APPAR. | General Theraphysical, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781320 | SHORTWAVE THERAPY APPAR. CURAMED 401 | General Theraphysical, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K780755 | SHORTWAVE DIATHERMY MODEL 802 | Birtcher Corp. | 1978-05-12 | Traditional | PDF ↗ |
| K771540 | MAGNATHERM 2000 | Intl. Medical Electronics , Ltd. | 1977-10-04 | Traditional | PDF ↗ |
Product code IMJ · Class II · Physical Medicine. Data: openFDA.