FDA 510(k)

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Numéro K : K261298 · 2026-08-20

DemandeurGuangdong Youmeng Electrical Technology Co., Ltd.

Date de décision2026-08-20

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K261298. 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 Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. The 510(k) number is K261298.

When did Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) receive FDA 510(k) clearance?

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) received FDA 510(k) clearance on 2026-08-20, under 510(k) number K261298.

Who is the listed applicant for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

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

What is the FDA product code for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

The FDA product code for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) is HGX.

Essais cliniques associés

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Autres dossiers indiquant Guangdong Youmeng Electrical Technology Co., Ltd. en tant que demandeur

K252342Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)K252754Wearable Electric Breast Pump (YM-8803)K232466Electric Breast Pump, model: YM-8166

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.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.

Source officielle

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