FDA 510(k)

自由脊髓刺激器（SCS）系統

K 號：K182720 · 2019-03-29

決定日期2019-03-29

產品代碼GZB

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

Freedom Spinal Cord Stimulator (SCS) System is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K182720. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Freedom Spinal Cord Stimulator (SCS) System?

Freedom Spinal Cord Stimulator (SCS) System is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K182720.

When did Freedom Spinal Cord Stimulator (SCS) System receive FDA 510(k) clearance?

Freedom Spinal Cord Stimulator (SCS) System received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182720.

Who is the listed applicant for Freedom Spinal Cord Stimulator (SCS) System?

The FDA 510(k) record lists Stimwave Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freedom Spinal Cord Stimulator (SCS) System?

The FDA product code for Freedom Spinal Cord Stimulator (SCS) System is GZB.

其他以 Stimwave Technologies Incorporated 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。

K180981刺激器套件、試驗套件、備用導線套件、可穿戴組裝套件 K172644沙灘鯊注射釘套件，注射導管手柄，帶釘加載桿，加載底座 K170141接收器套件、試驗套件、備用導線套件、无菌修復套件、可穿戴天線組裝套件及充電器套件 K162161接收器套件、試驗套件、備用導線套件、无菌修復套件、可穿戴天線組裝套件及充電器套件 K160600Freedom 脊髓刺激器系統

相關器械（代碼：GZB）

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。

K233801Nalu神經刺激系統用於脊髓刺激；Nalu神經刺激系統用於週邊神經刺激Boston Scientific Neuromodulation K221376納魯神經刺激系統Boston Scientific Neuromodulation K203547納魯神經刺激系統Boston Scientific Neuromodulation K202274Nalu神經刺激組合（lnte:gmted 40 em:單一8/雙8），Nalu神經刺激組合（Ported，2 em:單一8/雙8），雙8 Ported Nalu植入手動脈衝發生器，配備40 ern Kil，40 cm/ 60 cm/60 em TrialJExtension Lead Kits，病人組合包和各種備用組合包。Boston Scientific Neuromodulation K201618納魯神經刺激SCS系統Boston Scientific Neuromodulation K191466沙灘鯊注射锚釘系統 (SIA)Stimwave Technologies, Inc.

官方來源

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