FDA 510(k)

ウェアラブルブストプンプ（P9、P10、P16、P20、P21、P22、P23、P25）

K番号: K252192 · 2025-08-13

申請者Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

決定日2025-08-13

製品コードHGX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K252192. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)?

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K252192.

When did Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) receive FDA 510(k) clearance?

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) received FDA 510(k) clearance on 2025-08-13, under 510(k) number K252192.

Who is the listed applicant for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)?

The FDA 510(k) record lists Huizhou Lvb Maternal and Infant Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)?

The FDA product code for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is HGX.

申請者としてHuizhou Lvb Maternal and Infant Supplies Co., Ltd.を記載するその他の記録

K241004ウェアラブルブストプンプ（ABP-1508PRO、ABP-1506、ABP-1306、ABP-1306 PRO、M1、M3、M8、M5、M6、K1、K2、K3、K5、ABP-1306PLUS、ABP-1308、M2）K230102スマートダブルサイドウェアラブルブストポンプ、電動両側ブストポンプ

公式ソース

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