BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Youha electric breast pump

    K Number: K163136 · Decision Jul 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    4
    Review Days
    265

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Youha electric breast pump
    K Number
    K163136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Youhe Electrical Appliance Technology Co., Ltd.
    Date Received
    November 8, 2016
    Decision Date
    July 31, 2017
    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
    HGX Pump, Breast, Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HGX), ordered by most recent decision date.

    Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AViTA Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Mother's Nature W1 Warming Wearable Breast Pump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Spectra Platinum Mini

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Ningbo Youhe Electrical Appliance Technology Co., Ltd.

    K Number Device Name
    K251977 electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
    K242725 Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
    K203148 Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)