FDA 510(k)

脈衝電磁場包覆

K 號：K202337 · 2020-12-15

決定日期2020-12-15

產品代碼ILX

諮詢委員會PM

決定相當於

器材摘要

Pulsed electromagnetic field wrap is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) number K202337. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulsed electromagnetic field wrap?

Pulsed electromagnetic field wrap is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K202337.

When did Pulsed electromagnetic field wrap receive FDA 510(k) clearance?

Pulsed electromagnetic field wrap received FDA 510(k) clearance on 2020-12-15, under 510(k) number K202337.

Who is the listed applicant for Pulsed electromagnetic field wrap?

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

What is the FDA product code for Pulsed electromagnetic field wrap?

The FDA product code for Pulsed electromagnetic field wrap is ILX.

其他以 Hi-Dow International, Inc. 為申請人之記錄

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相關器械（代碼：ILX）

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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