FDA 510(k)

Momcozy穿戴式電動乳罩泵（型號：BP334、BP334-A、BP334-B、BP334-C、BP334-D、BP434）

K 號：K253914 · 2026-04-29

申請人Shenzhen Root Innovation Technology Co., Ltd.

決定日期2026-04-29

產品代碼HGX

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

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K253914. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253914.

When did Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) receive FDA 510(k) clearance?

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) received FDA 510(k) clearance on 2026-04-29, under 510(k) number K253914.

Who is the listed applicant for Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)?

The FDA product code for Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) is HGX.

其他以 Shenzhen Root Innovation Technology 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。

K254254Momcozy穿戴式乳泵（BP311、BP311-A、BP311-B、BP311-C、BP311-D）K260538Momcozy 携帶式乳泵 (BP420, BP420-A, BP420-B, BP420-C, BP420-D)K253629Momcozy 鼻吸器 (BN007)K260134嬰兒鼻吸器（BN006、BN006-A、BN006-B、BN006-C、BN006-D、BN02；BN008、BN008-A、BN008-B、BN008-C、BN008-D、BC-021）K254258Momcozy穿戴式乳泵（BP137、BP137-A、BP137-B、BP137-C、BP137-D、BP137Y-A、BP137Y-B、BP141、BP141-A、BP141-B、BP141-C、BP141-D）K253946Momcozy穿戴式電動乳泵（S9 Pro、S9 Pro-A、S9 Pro-B、S9 Pro-C、S9 Pro-D、S9 ProY-A、S9 ProY-B、S9 ProY-C、S12 Pro、S12 Pro-A、S12 Pro-B、S12 Pro-C、S12 Pro-D、S12 ProY-A、S12 ProY-B、S12 ProY-C）

查看所有 13 項裝置 →

相關器械（代碼：HGX）

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。

K254203穿戴式乳泵（型號 S36）Shenzhen TPH Technology Co., Ltd.K261622飛利浦安進自然照護免手提電動乳罩泵（型號：SCF593/52，SCF593/62）；飛利浦安進自然照護加熱免手提電動乳罩泵（型號：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774穿戴式乳泵（型號：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre雙倍MaxCimilre Co., Ltd.K261298穿戴式電動乳泵 (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流動式穿戴乳房抽乳器（型號 S3）Shenzhen TPH Technology Co., Ltd.

官方來源

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