IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class II
FDA Device Classification
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 |