FDA 510(k)

DR-HO's 腰痛緩解系統 Pro（型號 BPRS-I 和 BPRS-II）

K 號：K202671 · 2021-11-12

決定日期2021-11-12

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

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K202671. 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 DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K202671.

When did DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) receive FDA 510(k) clearance?

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K202671.

Who is the listed applicant for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

The FDA product code for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is NUH.

其他以 Guangzhou Xinbo Electronic 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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