510(k) · Cleared
ClearedRecoveryRx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioelectronics Corporation · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Jun 28, 2019 as substantially equivalent to K022404 (Paw, LLC, 2002) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jun 28, 2019
- Review
- 141 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903675 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| −1 | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| 0 (this device) | K190251 | RecoveryRx | Bioelectronics Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022404 | ActibandSummary page 4…Therapy 6. Product Classification: 21 CFR 890.5290 (b) Product Code: ILX 7. Predicate Devices: Primary Predicate: ActiBand (K022404) Secondary Predicate: Ivivi (K070541) 8. Description of Device: T… | 2002 |
| * | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IISummary page 4…Product Code: ILX 7. Predicate Devices: Primary Predicate: ActiBand (K022404) Secondary Predicate: Ivivi (K070541) 8. Description of Device: The RecoveryRx® device is a pulsed shortwave therapy… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K022404.
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. 2019, 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?
Adjunctive treatment of postoperative pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190251 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190251: RecoveryRx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190251
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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