GIM-STIM 非處方電擊療法/電肌肉刺激系統
K 號：K190988 · 2019-08-16
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器材摘要
GIM-STIM OTC TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K190988. 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 GIM-STIM OTC TENS/EMS System?
GIM-STIM OTC TENS/EMS System is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K190988.
When did GIM-STIM OTC TENS/EMS System receive FDA 510(k) clearance?
GIM-STIM OTC TENS/EMS System received FDA 510(k) clearance on 2019-08-16, under 510(k) number K190988.
Who is the listed applicant for GIM-STIM OTC TENS/EMS System?
The FDA 510(k) record lists Gemore Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GIM-STIM OTC TENS/EMS System?
The FDA product code for GIM-STIM OTC TENS/EMS System is NUH.
相關臨床試驗
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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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官方來源
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