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Wearable Breast Pump (Model FS12A) +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K250843
Identifiers
- 510(k) Number
- K250843 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
- Models / Variants
- Wearable Breast Pump (Model FS12A) FDA 510(k)Wearable Breast Pump (Model FS12B) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Wearable Breast Pump (Model FS12A) +1 more model by Shenzhen TPH Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 2 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250843 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen TPH Technology Co., Ltd
- FDA Applicant
- Shenzhen TPH Technology Co., Ltd.
Sources (1)
- FDA 510(k) K250843 24 fields · synced Jun 18, 2026