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510(k) Data Aggregation

    K Number
    K251622

    Validate with FDA (Live)

    Device Name
    Hand Massager (SM004D)
    Manufacturer
    Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
    Date Cleared
    2026-01-28

    (245 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    18 - 64
    Reference & Predicate Devices
    K203552
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hand Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.

    The Hand Massager is indicated for temporary relief of minor muscle aches and pains and for a temporary increase in circulation to the treated areas in generally healthy adults.

    Device Description

    This hand massager is intended for use by healthy adults to temporarily relieve minor muscle aches and pains in the hand and wrist and to temporarily increase local circulation. It is particularly suitable for relaxing hand muscles after repetitive activities.

    Charge this product using the supplied USB cable and a 5 V USB power adapter (1 A or 2 A). Do not use rapid/fast charging or a power adapter that outputs more than 6 V. The power indicator flashes during charging and turns off when fully charged. This product cannot be turned on or operated while it is being charged.

    AI/ML Overview

    N/A

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