510(k) · Cleared
ClearedAM800 Automove Emg Triggered Electrical Muscle Stimulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dan Med, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Nov 10, 1997 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Nov 10, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK972997 AM800 Automove Emg Triggered Electrical Muscle StimulationDan Med, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK053266 Myotrac InfinitiThought Technology, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK070425 Vitalstim ExperiaChattanooga Group · 2007
- Descendant · 2 generations on · 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K053266Myotrac InfinitiThought Technology, Ltd. · 2005 · cites it directly4descendants
- K070425Vitalstim ExperiaChattanooga Group · 2007 · cites it directly2descendants
- K211094Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2021 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K972997 | AM800 Automove Emg Triggered Electrical Muscle Stimulation | Dan Med, Inc. | 1997 | — |
| +1 | K053266 | Myotrac Infiniti | Thought Technology, Ltd. | 2005 | — |
| +1 | K070425 | Vitalstim Experia | Chattanooga Group | 2007 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 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?
- Of its descendants, K053266 (Thought Technology, Ltd., 2005) has gone furthest, with 4 descendants of its own.
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?
Stroke Rehab by Muscle Reeducation
Relaxation of muscle spasms.
Prevention of retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Maintaining or increasing range of motion.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972997 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972997
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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