510(k) K242725

Device
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
Applicant
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
510(k) number
K242725
Product code
HGX
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-30
Date received
2024-09-10
Regulation
884.5160
Classification name
Pump, Breast, Powered
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yun Jun Huang
Address
#567,Xintang Rd.,Fuhai Town Cixi CN 315322 315322

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260956Spectra Platinum MiniUzinmedicare Co., Ltd.2026-06-04
K254300eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)Anker Innovations Limited2026-05-29
K254244Wearable Breast Pump (Model S39)Shenzhen TPH Technology Co., Ltd.2026-05-21
K254125Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2026-05-13
K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)Shenzhen Root Innovation Technology Co., Ltd.2026-04-29
K260239Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)Jiangxi AOV Maternity & Baby Products Co., Ltd.2026-04-22
K253510Freestyle Mini Hands-freeMedela, LLC2026-04-10
K260033Wearable Breast Pump (Model S21A)Shenzhen TPH Technology Co., Ltd.2026-04-08
K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)Shenzhen Root Innovation Technology Co., Ltd.2026-04-08
K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)Shenzhen Root Innovation Technology Co., Ltd.2026-04-07
K250208SPECTRA Wearable 2Uzinmedicare Co., Ltd.2026-04-06
K252744Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)Cixi Ruihong Electric Appliance Co., Ltd.2026-04-03
K252583Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)A Cute Baby, Inc.2026-03-12
K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)Shenzhen Root Innovation Technology Co., Ltd.2026-03-09
K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLC2026-02-13