Product code IMI
- Device name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5300
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025-06-04 |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | 2023-10-24 |
| K222098 | ManaSport+ | Manamed, Inc. | 2023-03-08 |
| K210284 | ManaSport | Manamed, Inc. | 2022-04-26 |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021-12-23 |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical , Ltd. | 2017-08-25 |
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016-11-10 |
| K160075 | Accent XL | Alma Lasers, Inc. | 2016-08-17 |
| K161502 | MC1 Plus | General Project S.R.L. | 2016-08-16 |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | Ibramed Equipamentos Medicos | 2014-01-27 |
| K130888 | SONOPULSE/ SONOPULSE III | Ibramed- Industria Brazileria DE Equipamentos Medi | 2014-01-09 |
| K124010 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2013-08-23 |
| K120171 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2012-05-04 |
| K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011-10-26 |
| K091615 | MED CONTOUR | General Project S.R.L. | 2010-05-06 |
| K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 | Sun-Rain System Corp. | 2009-10-23 |
| K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM | Hill Laboratories Co. | 2007-02-26 |
| K053041 | MED SCULPT | General Project S.R.L. | 2006-08-02 |
| K052934 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | S.O.R. Internacional, S.A. | 2006-06-12 |
| K053546 | SONICATOR 740, MODEL ME 740 | Mettler Electronics Corp. | 2006-05-04 |
| K050410 | HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) | Hwang Sun Enterprise Co., Ltd. | 2005-07-14 |
| K040798 | HES ULTRASONIC THERAPY APPLIANCE | Hwang Sun Enterprise Co., Ltd. | 2004-08-04 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Chattanooga Group | 2003-12-03 |
| K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 | Sun-Rain System Corp. | 2003-10-31 |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Dynatronics Corp. | 2003-10-22 |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Ito Co., Ltd. | 2003-10-09 |
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Sybaritic, Inc. | 2003-07-02 |
| K030878 | ACCOUSONIC, MODEL AS-270 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Metron Medical Australia, Pty, Ltd. | 2003-02-20 |
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| 00850030915221 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 00850030915214 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 00850030915191 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 17290110122161 | Opus Colibri 1mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122154 | Opus Colibri 0.7mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122178 | Opus Colibri 0.7mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122185 | Opus Colibri 1mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122192 | Glide Disposable Tip (x1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122208 | Glide Disposable Tip Set (X12) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122086 | Opus Plasma Applicator | ALMA LASERS LTD. | 2021-01-25 |
| 17290110121805 | Opus Plasma HP/Applicator | ALMA LASERS LTD. | 2020-02-17 |
| 17290110121768 | Accent Elite System 110V (Black) | ALMA LASERS LTD. | 2019-12-31 |
| 17290110121775 | RF Pixel HP for Accent Elite System (110V) | ALMA LASERS LTD. | 2019-12-31 |
| 17290110121690 | Mini Speed HP | ALMA LASERS LTD. | 2019-03-24 |
| 17290110121683 | Accent system | ALMA LASERS LTD. | 2019-03-08 |
| 00092237901045 | CM4 Winner Evo Device - 120V | Drive Devilbiss Healthcare | 2018-09-27 |
| 07898961579078 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579092 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579085 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579061 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 00850958007619 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007916 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 10660584000338 | Dynatron Solaris Plus 709 | Dynatronics Corporation | 2016-09-24 |
| 10660584000147 | Dynatron 25 Series 125B | Dynatronics Corporation | 2016-09-24 |
| 10660584000116 | Dynatron 25 Series 825B | Dynatronics Corporation | 2016-09-24 |
| 10660584000109 | Dynatron 25 Series 925B | Dynatronics Corporation | 2016-09-24 |
| 10660584000024 | Dynatron Solaris Plus 708 | Dynatronics Corporation | 2016-09-24 |
| 10660584000017 | Dynatron Solaris Plus 709 | Dynatronics Corporation | 2016-09-24 |