FDA 510(k)

Wearable Breast Pump (Model S21)

N.º K: K250368 · 2025-05-30

SolicitanteShenzhen TPH Technology Co., Ltd.

Fecha de decisión2025-05-30

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wearable Breast Pump (Model S21) 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 2025-05-30 under 510(k) number K250368. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Wearable Breast Pump (Model S21)?

Wearable Breast Pump (Model S21) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250368.

When did Wearable Breast Pump (Model S21) receive FDA 510(k) clearance?

Wearable Breast Pump (Model S21) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250368.

Who is the listed applicant for Wearable Breast Pump (Model S21)?

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 Wearable Breast Pump (Model S21)?

The FDA product code for Wearable Breast Pump (Model S21) is HGX.

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Otros registros que enlistan a Shenzhen TPH Technology Co., Ltd. como solicitante

K254203Wearable Breast Pump (Model S36)K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)K261199Wearable Breast Pump (Model S32A)K260864Mother's Nature W1 Warming Wearable Breast Pump K254244Wearable Breast Pump (Model S39)K260033Wearable Breast Pump (Model S21A)

Ver todos los 24 dispositivos →

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.