IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Class II
FDA Device Classification
Classification Details
- Product Code
- IMJ
- Device Class
- Class II
- Regulation Number
- 890.5290
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250376 | viatherm therapeutics | ViVY | November 5, 2025 |
| K243112 | enraf-nonius | Curapuls 670 | June 25, 2025 |
| K223620 | regenesis biomedical | Reprieve by RegenesisTM | May 24, 2023 |
| K182363 | btl industries | BTL-703 | January 24, 2019 |
| K173300 | viatherm therapeutics | ViaTherm BOOST | May 1, 2018 |
| K162240 | promedtek | ProMedTek Model C1400 Shortwave Diathermy Device | November 17, 2016 |
| K161862 | zimmer medizinsysteme | ThermoPro | November 14, 2016 |
| K153456 | accelerated care plus | Megapulse III Shortwave Diathermy | June 14, 2016 |
| K131926 | ibramed equipamentos medicos | THERMOPULSE | July 24, 2014 |
| K131899 | shenzhen dongdixin technology co | SW-THERM | March 14, 2014 |
| K121123 | rocky mountain biosystems | BIOFUSIONARY BEBE | March 10, 2014 |
| K120093 | btl industries | BTL ELITE | October 5, 2012 |
| K083433 | chattanooga group | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | March 18, 2009 |
| K042554 | mettler electronics | AUTO THERM 390, MODEL ME 390 | October 8, 2004 |
| K030382 | selicor | SELITHERM, MODEL C100 | April 1, 2003 |
| K022846 | ito co | SW-180 SHORTWAVE THERAPY UNIT | January 28, 2003 |
| K022458 | mettler electronics | AUTO*THERM 395, MODEL ME 395 | September 26, 2002 |
| K020227 | selicor | SELICOR, MODELS A100 & D100 | July 30, 2002 |
| K973732 | pti | MEGAPULSE II | January 23, 1998 |
| K964083 | sie-med | ULTRATHERM (908) | April 3, 1997 |