BEUDAMED
    Product Code: LYG FDA class 1 21 CFR 890.5660

    Massager, Therapeutic, Manual

    Physical Medicine

    The Manual Therapeutic Massager (product code LYG) is a hand-operated physical medicine device used to apply therapeutic massage to muscles and soft tissues for pain relief, relaxation, and rehabilitation. Regulated under 21 CFR 890.5660 and classified as a Class 1 device subject only to general controls, it falls under the Physical Medicine specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.

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    510(k)s
    13
    FEI Numbers
    197
    Registration Numbers
    197
    Unique Applicants
    12
    Years Active
    8

    Basic Information

    Product Code
    LYG
    Device Class
    FDA class 1
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 13 510(k) clearances via K numbers.

    K Number Device Name
    K963704 MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
    K936312 MANUAL MASSAGE ROLLER
    K952043 BACK MASSAGER
    K930613 HOOKING SYSTEM
    K936148 STRESS HANDLER
    K924315 THE MASSAGER
    K922366 SPINE LINE
    K915361 THE BODY BUGGY
    K912512 TAICHI STICK MASSAGER
    K903820 THERA-CANE
    K884907 BUMPY MEDICAL MASSAGE MAT
    K881081 DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER
    K881080 DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER

    FEI Numbers

    This FDA classification entry is associated with 197 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 197 registration numbers. Click on an entry to view related FDA registrations.