BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Otsuka Precision Health, Inc.

    Reg #: 3010447004 · FEI: 3010447004 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Otsuka Precision Health, Inc.
    Registration Number
    3010447004
    FEI Number
    3010447004
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    508 Carnegie Ctr
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231209

    Owner / Operator

    Firm Name
    Otsuka Precision Health, Inc.
    Operator Number
    10094881
    Address
    508 CARNEGIE CENTER DRIVE
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Computerized Behavioral Therapy Device For Depressive Disorders. SAP

    Proprietary Names

    Rejoyn

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility