510(k) · Cleared
ClearedPulsed electromagnetic field wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hi-Dow International, Inc. · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Dec 15, 2020 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 15, 2020
- Review
- 120 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK202337 Pulsed electromagnetic field wrapHi-Dow International, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK241395 Active System; Avenue8Caerus Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K241395Active System; Avenue8Caerus Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K202337 | Pulsed electromagnetic field wrap | Hi-Dow International, Inc. | 2020 | — |
| +1 | K241395 | Active System; Avenue8 | Caerus Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ILX device
- #1 K241395 Active System; Avenue8score 9.4 · 4 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241395 | Active System; Avenue8 | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K241395 (Caerus Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ILX devicesILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ILX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ILX
Too few ILX 510(k)s in any year since 2007 to give a median.
Recalls per year · ILX
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILX
1in 2025
MAUDE reports naming product code ILX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and joint aches and pain associated with overexertion, strains, sprains and arthritis.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202337: Pulsed electromagnetic field wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202337
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026