510(k) · Cleared
ClearedExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aneuvo · SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Cleared on Mar 27, 2026 as substantially equivalent to DEN240014 (Onward Medical, Inc., 2024) after a 197-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Mar 27, 2026
- Review
- 197 days
- Class
- Class II
- Product code
- SDO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240014 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240014 ARC-EX SystemOnward Medical, Inc. · 2024
- This deviceK252893 ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System…Aneuvo · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024 | — |
| 0 (this device) | K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011)… | Aneuvo | 2026 | — |
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 SDO? 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 SDO device
- #1 K253638 xStep (xStep)score 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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.
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN240014.
How does its category compare?
All SDO devicesSDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SDO
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SDO
Too few SDO 510(k)s in any year since 2007 to give a median.
Recalls per year · SDO
No recall names SDO since 2007.
Adverse event reports per year · SDO
No MAUDE report names SDO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ExaStim Stimulation System is indicated for the improvement of hand sensation and strength in individuals between 18 and 75 years old who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury, when used in conjunction with functional task practice.
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/K252893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252893: ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252893
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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