FDA 510(k)

馬格韻痛療法：MagPro R30、MagPro R30 配備 MagOption、MagPro X100、MagPro X100 配備 MagOption

K 號：K230014 · 2023-08-25

決定日期2023-08-25

產品代碼QPL

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

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230014. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K230014.

When did MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption receive FDA 510(k) clearance?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230014.

Who is the listed applicant for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

The FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is QPL.

其他以 Tonica Elektronik A/S 為申請人之記錄

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相關器械（代碼：QPL）

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。

K250309BTL-199BTL Industries, Inc.K250286Rapid2 靜磁刺激器（Magstim Rapid2、Magstim Super Rapid2、Magstim Super Rapid2 Plus1）The Magstim Company Limited K241785StarFormer (M008-3T)Fotona D.O.O.K233364Axon 療法Neuralace Medical, Inc.K210021Axon 療法Neuralace Medical, Inc.

官方來源

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