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FDA 510(k)

Sway System (Sports Plus)

K-Number: K262000 · 2026-10-18

ApplicantSway Medical, Inc.
Decision Date2026-10-18
Product CodePOM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sway System (Sports Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Sway Medical, Inc.. It received FDA 510(k) clearance on 2026-10-18 under 510(k) number K262000. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sway System (Sports Plus)?

Sway System (Sports Plus) is a medical device that received FDA 510(k) clearance on 2026-10-18. The listed applicant is Sway Medical, Inc.. The 510(k) number is K262000.

When did Sway System (Sports Plus) receive FDA 510(k) clearance?

Sway System (Sports Plus) received FDA 510(k) clearance on 2026-10-18, under 510(k) number K262000.

Who is the listed applicant for Sway System (Sports Plus)?

The FDA 510(k) record lists Sway Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sway System (Sports Plus)?

The FDA product code for Sway System (Sports Plus) is POM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Sway Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241737Sway System Sports Plus

Related Devices (Code: POM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241737Sway System Sports PlusSway Medical, Inc.K231688ImPACT Version 4Impact Applications, Inc.K201376ANAM Test SystemVista Lifesciences, Inc.K202485ImPACT Version 4Impact Applications, Inc.K181223ImPACTImpact Applications, Inc.K170551ImPACT Quick TestImpact Applications, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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