510(k) · Cleared
ClearedMyotrac Infiniti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thought Technology, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 29, 2005 as substantially equivalent to K972997 (Dan Med, Inc., 1997) and 1 other predicate after a 36-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it.
- Decided
- Dec 29, 2005
- Review
- 36 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880235 (1988). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK880235 Intelect Model 120Chattanooga Group, Inc. · 1988
- 1 generation backK031017 Sys*Stim 208 and 208AMettler Electronics Corp. · 2003
- This deviceK053266 Myotrac InfinitiThought Technology, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK070425 Vitalstim ExperiaChattanooga Group · 2007
- Descendant · cites it directly · 0 of its ownK211094 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2021
- Descendant · 2 generations on · 0 of its ownK153224 VitalStim (R) Plus Electrotherapy SystemDjo, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK120922 Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K070425Vitalstim ExperiaChattanooga Group · 2007 · cites it directly2descendants
- K211094Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2021 · cites it directly0descendants
- K153224VitalStim (R) Plus Electrotherapy SystemDjo, LLC · 2016 · 2 generations on0descendants
- K120922Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880235 | Intelect Model 120 | Chattanooga Group, Inc. | 1988 | — |
| −1 | K031017 | Sys*Stim 208 and 208A | Mettler Electronics Corp. | 2003 | — |
| 0 (this device) | K053266 | Myotrac Infiniti | Thought Technology, Ltd. | 2005 | — |
| +1 | K070425 | Vitalstim Experia | Chattanooga Group | 2007 | — |
| +1 | K211094 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2021 | — |
| +2 | K153224 | VitalStim (R) Plus Electrotherapy System | Djo, LLC | 2016 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K972997 | AM800 Automove Emg Triggered Electrical Muscle StimulationSummary page 2…asslI (882.5050 and 890.5850) Predicate Devices Trade Name: Danmeter AutoMove AM800 EMG Triggered Stimulator (K972997) Classification Name: 891PF, 84HCC, Classli Trade Name: Mettler Electronics Corp Sys STIM 208 powered… | 1997 |
| * | K031017 | Sys*Stim 208 and 208ASummary page 2…ication Name: 891PF, 84HCC, Classli Trade Name: Mettler Electronics Corp Sys STIM 208 powered muscle stimulator (K031017) Classification Name: 89IPF, Classli Description of Device: The MyoTrac Infiniti device is an electrical muscle stimul… | 2003 |
| † | K874469 | Transcutaneous Electric Nerve Stimulation (Tens) | 1988 |
| † | K935213 | Incontrol | 1995 |
| † | K903497 | Flexcomp DSP & Procomp | 1991 |
What descends from it? (4)
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 17 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070425 (Chattanooga Group, 2007) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K972997.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053266: Myotrac Infiniti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053266
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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