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

    Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

    K Number: K211942 · Decision Dec 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    173

    Basic Information

    Device Name
    Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
    K Number
    K211942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen OSTO Technology Company Limited
    Date Received
    June 23, 2021
    Decision Date
    December 13, 2021
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    Similar 510(k) Clearances

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

    Pure Impact

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XBody Go USA, XBody Pro USA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Muscle Stimulator Device (PZ-100)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Limfa Therapy System (Limfa Therapy)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SofWave System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Wireless TENS & EMS Unit

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Shenzhen OSTO Technology Company Limited

    K Number Device Name
    K213056 LED Facial Mask
    K211736 Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
    K210756 Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
    K190783 Health Expert Electronic Stimulator (model: AST-3000L)
    K190673 Health Expert Electronic Stimulator