FDA 510(k)

J.O. 椰子混合保暖個人潤滑劑

K 號：K232090 · 2023-10-11

決定日期2023-10-11

產品代碼NUC

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

JO Coconut Hybrid Warming Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is CC Wellness, LLC. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232090. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JO Coconut Hybrid Warming Personal Lubricant?

JO Coconut Hybrid Warming Personal Lubricant is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is CC Wellness, LLC. The 510(k) number is K232090.

When did JO Coconut Hybrid Warming Personal Lubricant receive FDA 510(k) clearance?

JO Coconut Hybrid Warming Personal Lubricant received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232090.

Who is the listed applicant for JO Coconut Hybrid Warming Personal Lubricant?

The FDA 510(k) record lists CC Wellness, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JO Coconut Hybrid Warming Personal Lubricant?

The FDA product code for JO Coconut Hybrid Warming Personal Lubricant is NUC.

其他以 CC Wellness, LLC 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。

K232091椰子混合冷效個人潤滑劑 K230674JO 水基分析濃滑潤滑劑 2oz 型號 40112, JO 水基分析濃滑潤滑劑 4oz 型號 40112, JO 水基分析濃滑潤滑劑 8oz 型號 40114 K221908JO CUMPLAY 個人潤滑劑 K212885Actively Trying Personal Lubricant Rose Scented K212705Actively Trying Personal Lubricant Unfragrance K210986H2O冷卻個人潤滑劑，H2O分析冷卻個人潤滑劑，#LubeLife Sensations冷卻，#LubeLife Sensations雙人快樂套裝，JO 2 To Tango for Me，JO 2 To Tango夫妻快樂套裝

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相關器械（代碼：NUC）

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。

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer 水基潤滑劑（WL-OJ）；HARU Orgasm 水基潤滑劑（WL-OR）；HARU STEAMY 水基潤滑劑（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP 水基個人潤滑劑及保濕劑PINKSLIP, LLC K261909Plum Vagiceuticals™ 阴道潤滑栓PCCA, Inc.K254011流動水性個人潤滑劑LBDO Group, Inc.

官方來源

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