Ameda GLO Wearable Breast Pump (Model W8S)— 510(k) K250463
Substantially EquivalentShenzhen TPH Technology Co., Ltd.
FDA 510(k) clearance K250463 for Ameda GLO Wearable Breast Pump (Model W8S), Substantially Equivalent on 2025-03-20. Applicant: Shenzhen TPH Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shenzhen, CN
Recent devices under product code HGX
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- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from Shenzhen TPH Technology Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.