IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Class II
FDA product code IMJ covers "Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat", a Class II medical device regulated under 21 CFR 890.5290. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252963 | btl industries | BTL-899TT | June 12, 2026 |
| 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 |