510(k) K260346
- Device
- Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
- Applicant
- Polybell (Guangzhou) Limited
- 510(k) number
- K260346
- Product code
- HGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2026-02-03
- 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
- Qingliang Xu
- Address
- # 50, W. St., Xihu Village, Renhe Town Baiyun District Guangzhou CN 510470 510470
FDA Registration Numbers#
- 3007770329
- 3007491602
- 3012119286
- 3012062596
- 3029923636
- 3027605322
- 3012316249
- 3006446479
- 3026986849
- 3012298445
- 3006610790
- 3003509351
- 3038613158
- 3017196081
- 3030978471
- 3010205626
- 3021635975
- 3016693518
- 3018514222
- 3005031124
- 2110540
- 3020034975
- 3024790242
- 3027841329
- 3010834934
- 3029950834
- 3018159965
- 3043515178
- 3010626066
- 3010334650
- 3013684412
- 3026400132
- 3000126629
- 3010880718
- 3008711096
- 3009124884
- 3011800804
- 3016975995
- 3020994856
- 3038296449
- 3030479957
- 3021244152
- 3002807523
- 3008138005
- 3010359222
- 3014166044
- 3030671608
- 3013513831
- 3003927385
- 3009700166
- 3006131984
- 3021376102
- 3006774448
- 1721686
- 3016245319
- 3025360194
- 3006179052
- 3042823784
- 3003446042
- 3012605672
- 3009617411
- 2381321
- 3013521677
- 3016915446
- 3027115730
- 3035880570
- 3020305857
- 3009826814
- 3011077581
- 1419937
- 3021544150
- 3016562061
- 3015501220
- 3013699454
- 3011139154
- 3043165985
- 3013053058
- 3010337881
- 1217805
Source Documents#
Other 510(k) Records For Product Code HGX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 |
| K250129 | AViTA Breast Pump | Avita Corporation | 2026-06-11 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | 2026-06-04 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | 2026-05-29 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | 2026-04-10 |
| K254258 | Momcozy 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 |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 |