FDA 510(k)

PowerDot PD-01MT2 肌肉刺激器

K 號：K210269 · 2021-02-23

決定日期2021-02-23

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

PowerDot PD-01MT2 Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K210269. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerDot PD-01MT2 Muscle Stimulator?

PowerDot PD-01MT2 Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K210269.

When did PowerDot PD-01MT2 Muscle Stimulator receive FDA 510(k) clearance?

PowerDot PD-01MT2 Muscle Stimulator received FDA 510(k) clearance on 2021-02-23, under 510(k) number K210269.

Who is the listed applicant for PowerDot PD-01MT2 Muscle Stimulator?

The FDA 510(k) record lists Smartmissimo Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDot PD-01MT2 Muscle Stimulator?

The FDA product code for PowerDot PD-01MT2 Muscle Stimulator is IPF.

其他以 Smartmissimo Technologies Pte, 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。

K210938PowerDot PD-01MT2 肌肉刺激器 K181759PowerDot PD-01MT K172876PowerDot PD-01M

相關器械（代碼：IPF）

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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