BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOINTELLISENSE INC.

    Reg #: 3016592682 · FEI: 3016592682 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    BIOINTELLISENSE INC.
    Registration Number
    3016592682
    FEI Number
    3016592682
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    805 Veterans Blvd, UNIT 105
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191614

    Owner / Operator

    Firm Name
    BioIntelliSense Inc.
    Operator Number
    10062701
    Address
    805 Veterans Blvd, UNIT 105
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    Yusi Liu

    Products

    Device Name Product Code
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Calculator, Drug Dose NDC
    Tape And Bandage, Adhesive KGX
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Bed Patient KMI

    Proprietary Names

    BioSticker™ BioSticker™ wearable sensor BioSticker™ on-body sensor BioSticker™ wearable device BioSticker ™ remote patient monitoring device BioButton™ BioButton™ wearable device BioButton™ remote patient monitoring device BioButton™ wearable sensor BioButton Adhesives v2 (2x5pcs and 50x5pcs, HT, ADD, ADH-AC1-BBR) BioButton Adhesives v1 (2x5pcs and 50x5pcs, OMI, ADB, ACCS-1-ST06-1-4F) BioButton Adhesive V2, Cold Seal (ADH-CS) BioButton Charging Station BioButton System (Multi-patient Use or MPU) BioButton MPU BioButton v3 BioButton Rechargeable (BBR) BioButton Rechargeable BioIntelliSense Body Orientation Tracker (BOT)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device