K253638
- 510(k) number
- K253638
- Device name
- xStep (xStep)
- Applicant
- Spinex, Inc. CA · US
- Product code
- SDO — Transcutaneous Electrical Spine Stimulator To Improv
- Decision date
- 2026-04-20
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K253638.pdf
Official FDA record: K253638
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.