FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
K Number: K253072
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
1
Review Days
91
Basic Information
- Device Name
- Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
- K Number
- K253072
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
- Date Received
- September 23, 2025
- Decision Date
- December 23, 2025
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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