FDA 510(k)

TENS & PMS（型號：SM9009、SM9021、SM9128H、SM9015、SM9055、SM9033）

K 號：K220283 · 2022-05-02

申請人Hong Qiangxing (Shenzhen) Electronics Limited

決定日期2022-05-02

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

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2022-05-02 under 510(k) number K220283. 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 TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220283.

When did TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) receive FDA 510(k) clearance?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) received FDA 510(k) clearance on 2022-05-02, under 510(k) number K220283.

Who is the listed applicant for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

The FDA product code for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is NUH.

其他以 Hong Qiangxing (Shenzhen) Electronics Limited 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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官方來源

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