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

    ComboRehab

    K Number: K150436 · Decision Nov 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    25
    Review Days
    267

    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
    ComboRehab
    K Number
    K150436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    February 19, 2015
    Decision Date
    November 13, 2015
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

    Similar 510(k) Clearances

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

    Ultrasound Therapy Workstation (XMS-UET2)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BTL-4000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SONICSTIMU COMBO THERAPEUTIC DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FUTURA

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

    Other Clearances by Shenzhen Dongdixin Technology Co., Ltd.

    K Number Device Name
    K240358 ShockPhysio Mobile (model SW3200 Basic)
    K213043 Levator Elite (Model LE9011)
    K210364 Migraine Tens Digital Pain Reliever
    K180331 Wireless Pain Relieve Device
    K171430 Incontinence Treatment Device, Model LT2061
    K173462 Wireless Pain Relieve Device Model: LT5018C
    K171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
    K162479 Smart Pain Reliever, Model LT5019
    K161735 Non-contact Forehead Thermometer
    K142976 UltraTENS
    Search all 25 clearances from Shenzhen Dongdixin Technology Co., Ltd. →