Data / Medical devices / China / Shenzhen TPH Technology Co., Ltd.
Shenzhen TPH Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 23 510(k) clearances
Shenzhen TPH Technology Co., Ltd. is registered with the FDA (registration 3016975995) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 23 510(k) clearances under its listings, the newest dated July 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016975995
- Address
- Room 203,2nd Floor,29th Building,Lianchuang Technology Park,No. 21 Bulan Road,Xialilang Community Nanwan Street,Longgang District,Shenzhen, Shenzhen Guangdong, China, 518115
- Owner or operator
- Shenzhen TPH Technology Co., Ltd. (10084349)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 14, 2022
- Registered through
- 2026
- Brand names listed
- Ameda GLO Wearable Breast Pump (Model W8S), Ardo Iris Wearable Breast Pump (Model Iris), Ardo Iris Wearable Breast Pump (Model S1DW), Ardo Melia Wearable Breast Pump (Model W8), Biamba Soft Thermo Plus Wearable Breast Pump(Model S07), Discreet Duo (Model S32/Code 53751), DiscreetDuo Wearable Pump (Model S32), DiscreetDuo Flow Wearable Breast Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 13, 2026 | K261199 | Wearable Breast Pump (Model S32A) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2026 | K260864 | Mother's Nature W1 Warming Wearable Breast Pump | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 21, 2026 | K254244 | Wearable Breast Pump (Model S39) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 8, 2026 | K260033 | Wearable Breast Pump (Model S21A) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 13, 2026 | K252422 | Wearable Breast Pump (Model W2) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 13, 2026 | K252420 | Wearable Breast Pump (Model W12) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| September 8, 2025 | K251754 | Wearable Breast Pump (Model S33) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| August 20, 2025 | K250383 | Wearable Breast Pump (Model W6) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 31, 2025 | K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 15, 2025 | K250350 | Thrive 2-in-1 Breast Pump (Model P3) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 30, 2025 | K250368 | Wearable Breast Pump (Model S21) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 30, 2025 | K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 21, 2025 | K243508 | Wearable breast pump (model S12A) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 17, 2025 | K250829 | Lacevo Wearable Breast Pump (Model S70) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| April 2, 2025 | K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| March 20, 2025 | K250463 | Ameda GLO Wearable Breast Pump (Model W8S) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 21, 2025 | K242850 | Wearable breast pump (model W8) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2024 | K240536 | Wearable Breast Pump (Model S32) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| July 14, 2023 | K223886 | Wearable Breast Pump (Model S18) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| January 4, 2023 | K222045 | Wearable Breast Pump (Model S1DW) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2022 | K220596 | Wearable Breast Pump (Model S9) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
| February 11, 2022 | K212180 | Wearable Breast Pump (Model S12) | HGX | Substantially Equivalent | Shenzhen TPH Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.