510(k) K903675
- Device
- MAGNETIC RESONANCE THERAPY DEVICE
- Applicant
- MRT, INC.
- 510(k) number
- K903675
- Product code
- ILX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-17
- Date received
- 1990-08-13
- Regulation
- 890.5290
- Classification name
- Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID SALOFF
- Address
- 1118 3rd St., Unit 208 Santa Monica CA US 90403 90403
FDA Registration Numbers#
- 3008216220
- 3010417025
- 2243374
- 3014308816
- 3004837702
- 3006850006
- 2032108
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241395 | Active System; Avenue8 | Caerus Corporation | 2024-12-18 |
| K202337 | Pulsed electromagnetic field wrap | Hi-Dow International, Inc. | 2020-12-15 |
| K190251 | RecoveryRx | Bioelectronics Corporation | 2019-06-28 |
| K131979 | PROVANT THERAPY SYSTEM | Regenesis Biomedical, Inc. | 2013-12-13 |
| K121702 | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE | Orthocor Medical | 2013-05-06 |
| K121338 | ZEOBI | Ivivi Health Science, LLC | 2012-07-27 |
| K091791 | PROVANT SYSTEM, MODEL 4201 | Regenesis Biomedical, Inc. | 2010-04-07 |
| K092044 | ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE | Orthocor Medical | 2009-12-18 |
| K091996 | ORTHOCOR KNEE SYSTEM BASIC | Orthocor Medical | 2009-12-15 |
| K070541 | IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II | Ivivi Technologies, Inc. | 2008-12-11 |
| K070931 | MODEL PMT850 | Promedtek, Inc. | 2007-05-24 |
| K022404 | ACTIBAND | Paw, LLC | 2002-08-08 |
| K972093 | REGENESIS MODEL 42 | Regenesis Biomedical, Inc. | 1997-10-21 |
| K882816 | PULSAR EM | Apex Medical, Inc. | 1989-04-27 |
Legacy Summary#
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FDA Review#
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