ILX — Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat Class II
FDA product code ILX covers "Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat", a Class II medical device regulated under 21 CFR 890.5290. Submissions are reviewed by the Physical Medicine panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ILX
- Device Class
- Class II
- Regulation Number
- 890.5290
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241395 | caerus corporation | Active System; Avenue8 | December 18, 2024 |
| K202337 | hi-dow international | Pulsed electromagnetic field wrap | December 15, 2020 |
| K190251 | bioelectronics corporation | RecoveryRx | June 28, 2019 |
| K131979 | regenesis biomedical | PROVANT THERAPY SYSTEM | December 13, 2013 |
| K121702 | orthocor medical | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE | May 6, 2013 |
| K121338 | ivivi health science | ZEOBI | July 27, 2012 |
| K091791 | regenesis biomedical | PROVANT SYSTEM, MODEL 4201 | April 7, 2010 |
| K092044 | orthocor medical | ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE | December 18, 2009 |
| K091996 | orthocor medical | ORTHOCOR KNEE SYSTEM BASIC | December 15, 2009 |
| K070541 | ivivi technologies | IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II | December 11, 2008 |
| K070931 | promedtek | MODEL PMT850 | May 24, 2007 |
| K022404 | paw | ACTIBAND | August 8, 2002 |
| K972093 | regenesis biomedical | REGENESIS MODEL 42 | October 21, 1997 |
| K903675 | mrt | MAGNETIC RESONANCE THERAPY DEVICE | January 17, 1991 |
| K882816 | apex medical | PULSAR EM | April 27, 1989 |