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510(k) Data Aggregation

    K Number
    K022387
    Device Name
    CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
    Manufacturer
    CRAFTMATIC ORGANIZATION, INC.
    Date Cleared
    2002-09-19

    (58 days)

    Product Code
    LLI
    Regulation Number
    880.5100
    Why did this record match?
    Product Code :

    LLI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - (1) May Provide Temporary Relief of Low Back Pain; - May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatirue (2) or: Overexertion; - May Provide Temporary Relief of Edema or Swelling of the Legs; (3) - May Provide Temporary Relief of Poor Local Blood Circulation of the Legs;" (4) - May Provide Temporary Relief from Symptoms of Hiatus Hernia; (5) - May Provide Temporary Relief from the Symptoms of Gastric Reflux; (6) - May Provide Temporary Relief of Nighttime Heattburn; (7) - The Optional Heating Accessory Provides Temporary Relief from Mild Arthritis (8) and Joint Pain, as well as Muscle Pain Associated with Stress and Tension; and - Sleeping in an Upright Position May Reduce or Fase Light and Occasional (ව) Snoring. **
    Device Description
    Craftmatic® Adjustable Beds are electrically powered adjustable beds for home use that adjust into 1001 various positions (e.g., raising the torso, the legs, or both to various heights). The beds have three primary components: (1) a steel bed frame with lift motors, (2) a mattress, and (3) a pendant control. Powered heating pads, which cover the entire mattress, and physical therapy pulsators (built-in massage units) are optional.
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