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FDA 510(k)

Sway System 運動加強系統

K 號：K241737 · 2025-02-15

申請人Sway Medical, Inc.
決定日期2025-02-15
產品代碼POM
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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 2025-02-15 under 510(k) number K241737. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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. The listed applicant is Sway Medical, Inc.. The 510(k) number is K241737.

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

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

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.

相關臨床試驗

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相關器械（代碼：POM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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