Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
Device Facts
| Record ID | K260239 |
|---|---|
| Device Name | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) |
| Applicant | Jiangxi AOV Maternity & Baby Products Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Apr 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.