Product code ILX
- Device name
- Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5290
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K903675 | MAGNETIC RESONANCE THERAPY DEVICE | Mrt, Inc. | 1991-01-17 |
| K882816 | PULSAR EM | Apex Medical, Inc. | 1989-04-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00851979007282 | OrthoCor Medical | Caerus Corp. | 2025-08-11 |
| 00851979007657 | OrthoCor Medical | Caerus Corp. | 2025-08-11 |
| 00851979007619 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007596 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007572 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007565 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007558 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007534 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007527 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007503 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007442 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007435 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007312 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007305 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007510 | OrthoCor Medical | Caerus Corp. | 2025-03-10 |
| 00851979007046 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007671 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007664 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007480 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007466 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007428 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007404 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007381 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007367 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007336 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007039 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007022 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00851979007015 | OrthoCor Medical | Caerus Corp. | 2025-03-03 |
| 00081009308007 | TrueStim | Hi-Dow International Incorporated | 2023-09-28 |
| 00851329005128 | RecoveryRx | BioElectronics Corporation | 2021-03-03 |