FDA 510(k)

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Numéro K : K242725 · 2025-05-30

DemandeurNingbo Youhe Electrical Appliance Technology Co., Ltd.

Date de décision2025-05-30

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K242725. 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 Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K242725.

When did Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) receive FDA 510(k) clearance?

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K242725.

Who is the listed applicant for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

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

What is the FDA product code for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)?

The FDA product code for Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) is HGX.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Ningbo Youhe Electrical Appliance Technology Co., Ltd. en tant que demandeur

K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)K163136Youha electric 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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