510(k) · Cleared
ClearedVitalstim Experia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · IPF Stimulator, Muscle, Powered
Cleared on Jun 11, 2007 as substantially equivalent to K023347 (Chattanooga Group, 2002) and 3 other predicates after a 118-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Jun 11, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K880235 (1988). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK880235 Intelect Model 120Chattanooga Group, Inc. · 1988
- 2 generations backK031017 Sys*Stim 208 and 208AMettler Electronics Corp. · 2003
- 1 generation backK053266 Myotrac InfinitiThought Technology, Ltd. · 2005
- This deviceK070425 Vitalstim ExperiaChattanooga Group · 2007
- Descendant · cites it directly · 0 of its ownK153224 VitalStim (R) Plus Electrotherapy SystemDjo, LLC · 2016
- Descendant · cites it directly · 0 of its ownK120922 Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc. · 2013
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 |
|---|---|---|---|---|---|
| −3 | K880235 | Intelect Model 120 | Chattanooga Group, Inc. | 1988 | — |
| −2 | K031017 | Sys*Stim 208 and 208A | Mettler Electronics Corp. | 2003 | — |
| −1 | K053266 | Myotrac Infiniti | Thought Technology, Ltd. | 2005 | — |
| 0 (this device) | K070425 | Vitalstim Experia | Chattanooga Group | 2007 | — |
| +1 | K153224 | VitalStim (R) Plus Electrotherapy System | Djo, LLC | 2016 | — |
| +1 | K120922 | Guardian Dysphagia Dual Channel Nmes Unit | Selectivemed Components, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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 19.7 · 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? (4)
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 |
|---|---|---|---|
| * | K023347 | Vital StimSummary page 2…etaryName Device ClassificationName(s), Regulation Number(s), Classification(s)and Product Code(s). K023347 Chattanooga Vitalstim Stimulator Muscle Powered, 890.5850, Class II, IPF K002410 Freed Bioelectric St… | 2002 |
| * | K002410 | Freed Bioelectric: Dysphagia Treatment DeviceSummary page 2…Classification(s)and Product Code(s). K023347 Chattanooga Vitalstim Stimulator Muscle Powered, 890.5850, Class II, IPF K002410 Freed Bioelectric Stimulator Muscle Powered, 890.5850, Class II, IPF K053266 Myotrac Infiniti Sti… | 2001 |
| * | K053266 | Myotrac InfinitiSummary page 2…nooga Vitalstim Stimulator Muscle Powered, 890.5850, Class II, IPF K002410 Freed Bioelectric Stimulator Muscle Powered, 890.5850, Class II, IPF K053266 Myotrac Infiniti Stimulator Muscle Powered, 890.5850, Class II, IPF Biofe… | 2005 |
| * | K972997 | AM800 Automove Emg Triggered Electrical Muscle StimulationSummary page 2…Myotrac Infiniti Stimulator Muscle Powered, 890.5850, Class II, IPF Biofeedback Device, 882.5050, Class II, HCC K972997 AM800 Automove Stimulator Muscle Powered, 890.5850, Class II, IPF with EMG Biofe… | 1997 |
What descends from it? (2)
2 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 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K153224 (Djo, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K023347.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070425: Vitalstim Experia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070425
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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