SPECTRA Wearable 2
Device Facts
| Record ID | K250208 |
|---|---|
| Device Name | SPECTRA Wearable 2 |
| Applicant | Uzinmedicare Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Apr 6, 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.
