FDA device listing
Wearable Breast Pump (Model S10),Wearable Breast Pump (Model S10pro),Wearable Breast Pump (Model S19),Wearable Breast…
FDA device listing 1714012853 · Shenzhen TPH Technology Co., Ltd.
Key facts
| Proprietary names | Wearable Breast Pump (Model S10),Wearable Breast Pump (Model S10pro),Wearable Breast Pump (Model S19),Wearable Breast Pump (Model S9),Wearable Breast Pump (YY-5030) |
|---|---|
| Owner/operator | Shenzhen TPH Technology Co., Ltd. |
| Owner/operator number | 10084349 |
| Premarket submissions | K220596 |
| Product codes | HGX |
| Device names | HGX - Pump, Breast, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.5160 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | SHENZHEN TPH TECHNOLOGY CO., LTD. |
| Establishment registrations | 3016975995 |
| FEI numbers | 3016975995 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database