FDA.reportPublic FDA data

510(k) K260864

Device
Mother's Nature W1 Warming Wearable Breast Pump
Applicant
Shenzhen TPH Technology Co., Ltd.
510(k) number
K260864
Product code
HGX
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-09
Date received
2026-03-17
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
N

Applicant Contact#

Contact
Dale WANG
Address
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park, Shenzhen CN 518000 518000

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
K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.2026-06-26
K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.2026-06-25
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.2026-06-18
K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.2026-06-17
K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)Polybell (Guangzhou) Limited2026-06-12
K250129AViTA Breast PumpAvita Corporation2026-06-11
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
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
K260033Wearable Breast Pump (Model S21A)Shenzhen TPH Technology Co., Ltd.2026-04-08