510(k) · Cleared
ClearedRevitive IX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actegy, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Jun 28, 2013 as substantially equivalent to K050046 (Compex Technologies, Inc., 2005) and 1 other predicate after a 240-day review. Its family tree reaches back 3 generations to 1994. 19 later devices descend from it.
- Decided
- Jun 28, 2013
- Review
- 240 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932299 (1994). 11 ancestors in all, the oldest K872976 (1987). 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 2 generations backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- 1 generation backK103719 Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011
- This deviceK123354 Revitive IXActegy, Ltd. · 2013
- Descendant · cites it directly · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 2 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
- Descendant · 3 generations on · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · 4 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · cites it directly17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 2 generations on11descendants
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021 · 3 generations on5descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · 3 generations on4descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −2 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| −1 | K103719 | Lifecare Conductive Garments | Everyway Medical Instruments Co.,Ltd | 2011 | — |
| 0 (this device) | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
| +1 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +2 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +3 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 | — |
| +3 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +4 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SSummary page 1…Powered muscle stimulator, 21 C.F.R. § 890.5850, Product code IPF Predicate Devices IF 3Wave Interferential Stimulator System, Model 711 OS, Compex Technologies, Inc. (K050046) Lifecare Garment Electrodes, Everyway Medical Instruments Co. Ltd. (K103719) Intended Use / Indications for Use… | 2005 |
| * | K103719 | Lifecare Conductive GarmentsSummary page 1…Devices IF 3Wave Interferential Stimulator System, Model 711 OS, Compex Technologies, Inc. (K050046) Lifecare Garment Electrodes, Everyway Medical Instruments Co. Ltd. (K103719) Intended Use / Indications for Use The Revitive IX is indicated for: ¢ Relaxation of muscle spasms; * Preventio… | 2011 |
What descends from it? (19)
See all 192 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K143207 (Actegy, Ltd., 2015) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K050046.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The Revitive IX device is indicated for:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
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/K123354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123354: Revitive IX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123354
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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