FDA product code ILX: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
ILX is the FDA product code for diathermy, shortwave, for use other than applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel. FDA has cleared 15 510(k) submissions under ILX, 1 in the last five years, from 11 different applicants. The average 510(k) review took 200 days (median 165); 216 days on average over the last three years. FDA has posted 1 recall for ILX devices.
Classification
| Field | Value |
|---|---|
| Device name | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5290 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for ILX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 141 |
| 2020 | 1 | 120 |
| 2024 | 1 | 216 |
Compare with all 510(k) review times · Search every ILX clearance
Top ILX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Regenesis Biomedical, Inc. | 3 | 2013-12-13 |
| Orthocor Medical | 3 | 2013-05-06 |
| Caerus Corporation | 1 | 2024-12-18 |
| Hi-Dow International, Inc. | 1 | 2020-12-15 |
| Bioelectronics Corporation | 1 | 2019-06-28 |
6 more applicants have ILX clearances. See the full list in Caduvo.
Most recent ILX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241395 | Caerus Corporation | Active System; Avenue8 | 2024-12-18 | 216 |
| K202337 | Hi-Dow International, Inc. | Pulsed electromagnetic field wrap | 2020-12-15 | 120 |
| K190251 | Bioelectronics Corporation | RecoveryRx | 2019-06-28 | 141 |
| K131979 | Regenesis Biomedical, Inc. | PROVANT THERAPY SYSTEM | 2013-12-13 | 168 |
| K121702 | Orthocor Medical | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE | 2013-05-06 | 332 |
Recalls for ILX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-09-29.
Frequently asked questions
What is FDA product code ILX?
ILX is the FDA product code for diathermy, shortwave, for use other than applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel.
What device class is ILX?
Class II, regulation 21 CFR 890.5290. Typical premarket route: 510(k).
How long does a 510(k) take for product code ILX?
Across 15 cleared submissions the average was 200 days from receipt to decision (median 165).
Which companies have the most ILX clearances?
Regenesis Biomedical, Inc. (3); Orthocor Medical (3); Caerus Corporation (1); Hi-Dow International, Inc. (1); Bioelectronics Corporation (1).
Have ILX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-09-29.
Next steps
- Run an FDA pathway report with predicate devices for product code ILX
- Run a recall and safety report across every ILX manufacturer
- Watch product code ILX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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