510(k) · Cleared
ClearedIvivi Sofpulse, Models 912-M10, ROMA3 and Torino II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivivi Technologies, Inc. · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Dec 11, 2008 as substantially equivalent to K903675 (Mrt, Inc., 1991) after a 654-day review. Its family tree reaches back 1 generation to 1991. 8 later devices descend from it.
- Decided
- Dec 11, 2008
- Review
- 654 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903675 (1991). 8 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- This deviceK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK092044 Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009
- Descendant · cites it directly · 2 of its ownK091996 Orthocor Knee System BasicOrthocor Medical · 2009
- Descendant · cites it directly · 1 of its ownK152432 ActiPatch (R)Bioelectronics Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK121702 Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013
- Descendant · 2 generations on · 0 of its ownK241395 Active System; Avenue8Caerus Corporation · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009 · cites it directly3descendants
- K091996Orthocor Knee System BasicOrthocor Medical · 2009 · cites it directly2descendants
- K152432ActiPatch (R)Bioelectronics Corporation · 2017 · cites it directly1descendant
- K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013 · 2 generations on1descendant
- K241395Active System; Avenue8Caerus Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| 0 (this device) | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| +1 | K092044 | Orthocor Knee System, Median, Large, X-Large | Orthocor Medical | 2009 | — |
| +1 | K091996 | Orthocor Knee System Basic | Orthocor Medical | 2009 | — |
| +1 | K152432 | ActiPatch (R) | Bioelectronics Corporation | 2017 | — |
| +2 | K121702 | Orthocor Active Device Orthocor General Use Active Device | Orthocor Medical | 2013 | — |
| +2 | K241395 | Active System; Avenue8 | Caerus Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K903675 | Magnetic Resonance Therapy DeviceSummary page 5…Northvale, New Jersey 07647 Corresponding Official: Mr. André DiMino Title: Executive Vice President Telephone: 201-767-6040 Fax: 201-784-0620 Predicate Device: MRT (K903675), Product Code: ILX (per 21 CFR Section 890.5290(b)) Device Description: SofPulse (912-M10, Roma® and Torino 1) devices are shor… | 1991 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2008, 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 use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070541
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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