Panels › Physical Medicine › Product code ILX · Class 2
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation 890.5290
0510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ILX
| Company | 510(k)s | Recalls |
|---|---|---|
| Regenesis Biomedical, Inc. | 3 | 1 |
| Orthocor Medical | 3 | 0 |
| Apex Medical, Inc. | 1 | 0 |
| Bioelectronics Corporation | 1 | 0 |
| Caerus Corporation | 1 | 0 |
| Hi-Dow International, Inc. | 1 | 0 |
| Ivivi Health Science, LLC | 1 | 0 |
| Ivivi Technologies, Inc. | 1 | 0 |
| Mrt, Inc. | 1 | 0 |
| Paw, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K241395 | Active System; Avenue8 Caerus Corporation | ILX |
| Dec 15, 2020 | K202337 | Pulsed electromagnetic field wrap Hi-Dow International, Inc. | ILX |
| Jun 28, 2019 | K190251 | RecoveryRx Bioelectronics Corporation | ILX |
| Dec 13, 2013 | K131979 | PROVANT THERAPY SYSTEM Regenesis Biomedical, Inc. | ILX |
| May 6, 2013 | K121702 | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE Orthocor Medical | ILX |
| Jul 27, 2012 | K121338 | ZEOBI Ivivi Health Science, LLC | ILX |
| Apr 7, 2010 | K091791 | PROVANT SYSTEM, MODEL 4201 Regenesis Biomedical, Inc. | ILX |
| Dec 18, 2009 | K092044 | ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE Orthocor Medical | ILX |
| Dec 15, 2009 | K091996 | ORTHOCOR KNEE SYSTEM BASIC Orthocor Medical | ILX |
| Dec 11, 2008 | K070541 | IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II Ivivi Technologies, Inc. | ILX |
| May 24, 2007 | K070931 | MODEL PMT850 Promedtek, Inc. | ILX |
| Aug 8, 2002 | K022404 | ACTIBAND Paw, LLC | ILX |
| Oct 21, 1997 | K972093 | REGENESIS MODEL 42 Regenesis Biomedical, Inc. | ILX |
| Jan 17, 1991 | K903675 | MAGNETIC RESONANCE THERAPY DEVICE Mrt, Inc. | ILX |
| Apr 27, 1989 | K882816 | PULSAR EM Apex Medical, Inc. | ILX |
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