FDA 510(k)

Elitone 男性用

K 號：K253285 · 2026-01-23

決定日期2026-01-23

產品代碼QAJ

諮詢委員會GU

決定相當於

器材摘要

Elitone for Men is the device name listed in this FDA 510(k) record. The listed applicant is Elidah, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K253285. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elitone for Men?

Elitone for Men is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Elidah, Inc.. The 510(k) number is K253285.

When did Elitone for Men receive FDA 510(k) clearance?

Elitone for Men received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253285.

Who is the listed applicant for Elitone for Men?

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

What is the FDA product code for Elitone for Men?

The FDA product code for Elitone for Men is QAJ.

其他以 Elidah, Inc. 為申請人之記錄

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。

K223884ELITONE 緊急尿失禁設備 K183585Elitone 裝置

相關器械（代碼：QAJ）

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。

K223884ELITONE 緊急尿失禁設備Elidah, Inc.K192357INNOVOAtlantic Therapeutics, Ltd.K183585Elitone 裝置Elidah, Inc.

官方來源

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