FDA 510(k)

雙輸出數位療法按摩器

K 號：K172834 · 2018-09-06

決定日期2018-09-06

產品代碼NUH

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

Dual output digital therapy massager is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K172834. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dual output digital therapy massager?

Dual output digital therapy massager is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172834.

When did Dual output digital therapy massager receive FDA 510(k) clearance?

Dual output digital therapy massager received FDA 510(k) clearance on 2018-09-06, under 510(k) number K172834.

Who is the listed applicant for Dual output digital therapy massager?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual output digital therapy massager?

The FDA product code for Dual output digital therapy massager is NUH.

其他以 Shenzhen Osto Technology Co., Ltd. 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。

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相關器械（代碼：NUH）

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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