xStep (xStep)— 510(k) K253638

Substantially Equivalent

Spinex, Inc.

FDA 510(k) clearance K253638 for xStep (xStep), Substantially Equivalent on 2026-04-20. Applicant: Spinex, Inc..

Clearance details

Applicant: Spinex, Inc.
Product code: Code SDO
Advisory panel: Physical Medicine
Date received: 2025-11-19
Decision date: 2026-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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