510(k) · Cleared
ClearedCombi 8 Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cec Electronica S.R.L. · IPF Stimulator, Muscle, Powered
Cleared on Jul 3, 2008 as substantially equivalent to K984114 (Mettler Electronics Corp., 1999) and 2 other predicates after a 461-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 3, 2008
- Review
- 461 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945509 (1995). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 1 generation backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- This deviceK070888 Combi 8 MaxCec Electronica S.R.L. · 2008
- Descendant · cites it directly · 1 of its ownK123642 Muscle Stimulation SystemNiveus Medical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK150742 Muscle Stimulation System 110Niveus Medical, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −1 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| 0 (this device) | K070888 | Combi 8 Max | Cec Electronica S.R.L. | 2008 | — |
| +1 | K123642 | Muscle Stimulation System | Niveus Medical, Inc. | 2013 | — |
| +2 | K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 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? (3)
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 |
|---|---|---|---|
| * | K984114 | Sys Stim 294, Model ME 294Summary page 1…istration Number: to be assigned Information on devices to which substantial equivalence is claimed: ____ 510K # Trade, or propriety ameMnfcue=ls K9841 14 SYS STYM 294 Mettler Electronics Corp. 1 K062354 Vectra Genisys… | 1999 |
| * | K062354 | Vectra Genisys VMS FRSummary page 1…laimed: ____ 510K # Trade, or propriety ameMnfcue=ls K9841 14 SYS STYM 294 Mettler Electronics Corp. 1 K062354 Vectra Genisys Chattanooga Group 1 K960969 Galva 5-T… | 2007 |
| * | K960969 | Galva 5-TSummary page 1…YS STYM 294 Mettler Electronics Corp. 1 K062354 Vectra Genisys Chattanooga Group 1 K960969 Galva 5-T Zimmer Elektromnedizin Gmbh 1 Technological characteristics, for each out… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123642 | Muscle Stimulation System | 2013 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K123642 (Niveus Medical, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K984114.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses: COMBI 4/8 DIGITAL, COMBI TREND 4/8 * 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. COMBI 4/8 MAX * Relaxation of muscle…
Read the full statement (124 words)
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses:
COMBI 4/8 DIGITAL, COMBI TREND 4/8
* 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.
COMBI 4/8 MAX
* 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.
For TENS waveform:
· Relief of chronic, intractable pain
· Adjunctive treatment of post surgical or post traumatic acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070888: Combi 8 Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070888
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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