# K252893: ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

- Pathway: 510(k) (Traditional)
- Applicant: Aneuvo
- Decided: Mar 27, 2026 after 197 days
- Product code: SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation)
- Device class: 2
- Regulation: 21 CFR 890.5851
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240014 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240014: ARC-EX System, Onward Medical, Inc. (2024) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K252893
Methodology: https://510kreport.com/methodology