Vivace
510(k) K232047
Vivace is a medical device (FDA Class II; FDA product code HGX, Pump, Breast, Powered) made by Unimom.Co, cleared under FDA 510(k) K232047 on 28 Mar 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232047 | Date28 Mar 2024 | StatusActive |
Official records
- FDA 510(k) database K232047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HGX
- Device class
- Class II
- Regulation
- 21 CFR Part 884.5160
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Similar devices
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- NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP by The First Years, Inc.
- Solo, Swing Maxi by Medela LLC
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- Motif Aura Glow breast pump (Model Motif Aura Glow) by Shenzhen TPH Technology Co., Ltd
- LUCINA MODEL MELODI by GENADYNE BIOTECHNOLOGIES INC.
- MilkMate Breast Pump by Milkmate Products, Inc.