510(k) K021483
- Device
- RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
- Applicant
- RICH-MAR CORP.
- 510(k) number
- K021483
- Product code
- IMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-13
- Date received
- 2002-05-08
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID RICHARDS
- Address
- P.O. Box 879 Inola OK US 74036 74036
FDA Registration Numbers#
- 1648700
- 2013558
- 3012316249
- 2011115
- 3013069546
- 9612147
- 3017264244
- 9616086
- 3014980461
- 1313525
- 3004167969
- 8010720
- 3005170249
- 3014315574
- 3033524168
- 3030151584
- 3010362721
- 3011767724
- 3009155917
- 3010280625
- 3009437400
- 3013917867
- 3037609256
Source Documents#
510(k) summary PDF not indicated by FDA
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| 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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases