# K253638: xStep (xStep)

- Pathway: 510(k) (Traditional)
- Applicant: Spinex, Inc.
- Decided: Apr 20, 2026 after 152 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 5.

## Indications for use
The xStep TM is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). The xStepTM device is for prescription use in patients ages 18-75 years old in a medical center.

Source page: https://510kreport.com/device/K253638
Methodology: https://510kreport.com/methodology