IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class II
FDA product code IMI covers "Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat", a Class II medical device regulated under 21 CFR 890.5300. 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
- IMI
- Device Class
- Class II
- Regulation Number
- 890.5300
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240788 | jkh health co | Ultrasound Stimulator | June 4, 2025 |
| K230472 | enraf-nonius | Sonopuls 190 | October 24, 2023 |
| K222098 | manamed | ManaSport+ | March 8, 2023 |
| K210284 | manamed | ManaSport | April 26, 2022 |
| K202788 | carci industria e comercio de aparelhos cirurgicos e orto | Sonomed IV, Sonomed V | December 23, 2021 |
| K160378 | brh medical | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | August 25, 2017 |
| K161628 | bonutti research | JAS Pulse(TM) Ultrasonic Therapy | November 10, 2016 |
| K160075 | alma lasers | Accent XL | August 17, 2016 |
| K161502 | general project | MC1 Plus | August 16, 2016 |
| K142976 | shenzhen dongdixin technology co | UltraTENS | August 26, 2015 |
| K131309 | ibramed equipamentos medicos | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | January 27, 2014 |
| K130888 | ibramed- industria brazileria de equipamentos medi | SONOPULSE/ SONOPULSE III | January 9, 2014 |
| K124010 | metron medical australia, pty | ACCUSONIC ADVANTAGE | August 23, 2013 |
| K120171 | metron medical australia, pty | ACCUSONIC ADVANTAGE | May 4, 2012 |
| K112520 | ito co | US-101L, US-103S | October 26, 2011 |
| K091615 | general project | MED CONTOUR | May 6, 2010 |
| K090542 | sun-rain system | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-8 | October 23, 2009 |
| K062256 | hill laboratories | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM | February 26, 2007 |
| K053041 | general project | MED SCULPT | August 2, 2006 |
| K052934 | s.o.r. internacional | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | June 12, 2006 |