510(k) K031329
- Device
- DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
- Applicant
- DYNATRONICS CORP.
- 510(k) number
- K031329
- Product code
- IMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-22
- Date received
- 2003-04-28
- Regulation
- 890.5300
- Classification name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RON HATCH
- Address
- 7030 Park Centre Dr. Salt Lake City UT US 84121 84121
FDA Registration Numbers#
- 3030151584
- 3010280625
- 3014315574
- 3012316249
- 3017264244
- 2013558
- 3005170249
- 3013917867
- 3011767724
- 3033524168
- 8010720
- 1648700
- 2011115
- 3010362721
- 3037609256
- 1313525
- 9612147
- 3009437400
- 3013069546
- 3009155917
- 9616086
- 3004167969
- 3014980461
Source Documents#
Other 510(k) Records For Product Code IMI #
| 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 |
Legacy Summary#
summary
FDA Review#
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