Sway System (Sports Plus)— 510(k) K262000

Substantially Equivalent

Sway Medical, Inc.

FDA 510(k) clearance K262000 for Sway System (Sports Plus), Substantially Equivalent on 2026-10-18. Applicant: Sway Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sway Medical, Inc.
Product code: Product code POM
Device class: Class 2
Regulation: 21 CFR 882.1471
Advisory panel: Neurology
Date received: 2026-06-15
Decision date: 2026-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.