BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FitRelief TENS&EMS Wireless Device

    K Number: K191938 · Decision Aug 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    406

    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
    FitRelief TENS&EMS Wireless Device
    K Number
    K191938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Heat IN A Click, LLC
    Date Received
    July 19, 2019
    Decision Date
    August 28, 2020
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    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.

    Diacore

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Zionic Pro Max (EMS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CoolTone

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Motive™ Muscle Stimulator for Lower Back (OT01-1003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    truFlex

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

    Other Clearances by Heat IN A Click, LLC

    K Number Device Name
    K253279 Feather/numiere 05 06 07 (05)
    K251871 FEATHER 01 02 03 04 (Model:01)
    K214015 Palm NRG cellulite body device (model: Palm NRG body device)
    K202055 Looper (Model: ZX-579S)
    K150308 Palm TENS