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FDA 510(k)

Sway System Sports Plus

K-Number: K241737 · 2025-02-15

ApplicantSway Medical, Inc.
Decision Date2025-02-15
Product CodePOM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sway System Sports Plus is a medical device manufactured by Sway Medical, Inc.. It received FDA 510(k) clearance on 2025-02-15 under approval number K241737. 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 2025-02-15. It is manufactured by Sway Medical, Inc.. The 510(k) number is K241737.

When was Sway System Sports Plus approved by the FDA?

Sway System Sports Plus received FDA 510(k) clearance on 2025-02-15, under approval number K241737.

What company makes Sway System Sports Plus?

Sway System Sports Plus is manufactured by Sway Medical, Inc..

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

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

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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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