FDA 510(k)

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

Numéro K : K252192 · 2025-08-13

DemandeurHuizhou Lvb Maternal and Infant Supplies Co., Ltd.

Date de décision2025-08-13

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Huizhou Lvb Maternal and Infant Supplies Co., Ltd. en tant que demandeur

K241004Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)K230102Smart double sides wearable breast pump, Electric bilateral breast pump

Dispositifs connexes (Code : HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Source officielle

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