xStep (xStep)— 510(k) K253638
Substantially EquivalentSpinex, Inc.
FDA 510(k) clearance K253638 for xStep (xStep), Substantially Equivalent on 2026-04-20. Applicant: Spinex, Inc.. Device class: 2.
Summary
Spinex's xStep is filed under product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation). The record lists the name as xStep (xStep) and doesn't describe the device beyond it and the code name.
Class II, 21 CFR 890.5851. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Spinex filed from Fremont, California. The decision came 152 calendar days after FDA received it (November 19, 2025 to April 20, 2026).
Clearance details
- Applicant
- Spinex, Inc.
- Product code
- Product code SDO
- Device class
- Class 2
- Regulation
- 21 CFR 890.5851
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code SDO
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