FDA 510(k)

Ameda GLO Wearable Breast Pump (Model W8S)

Número K: K250463 · 2025-03-20

RequerenteShenzhen TPH Technology Co., Ltd.

Data da decisão2025-03-20

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ameda GLO Wearable Breast Pump (Model W8S) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K250463. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ameda GLO Wearable Breast Pump (Model W8S)?

Ameda GLO Wearable Breast Pump (Model W8S) is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250463.

When did Ameda GLO Wearable Breast Pump (Model W8S) receive FDA 510(k) clearance?

Ameda GLO Wearable Breast Pump (Model W8S) received FDA 510(k) clearance on 2025-03-20, under 510(k) number K250463.

Who is the listed applicant for Ameda GLO Wearable Breast Pump (Model W8S)?

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

What is the FDA product code for Ameda GLO Wearable Breast Pump (Model W8S)?

The FDA product code for Ameda GLO Wearable Breast Pump (Model W8S) is HGX.

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Outros registros que listam Shenzhen TPH Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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