BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TEN COMFORT CORP.

    Reg #: 9616309 · FEI: 3003750857 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    TEN COMFORT CORP.
    Registration Number
    9616309
    FEI Number
    3003750857
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6F-3, No. 213, Fu-Ho Road, Yung-Ho District
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K931715

    Owner / Operator

    Firm Name
    TEN COMFORT CORP.
    Operator Number
    9038541
    Address
    6F-3, No. 213, Fu-Ho Road, Yung-Ho District
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    23450
    Country
    TW

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Massager, Therapeutic, Electric ISA
    Laparoscopic Accessories, Gynecologic NWV
    Transilluminator, Battery-Powered HJN
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Pack, Hot Or Cold, Reusable IME
    Pack, Hot Or Cold, Disposable IMD
    Pack, Hot Or Cold, Water Circulating ILO
    Infant Heel Warmer (Chemical Heat Pack) MPO

    Proprietary Names

    TEN COMFORT ELECTRONIC MASSAGER Disposable Scope Warmer, Clear Scope Kit Battery-Powered Transilluminator PURECARE AT-903 TENS HOTPAD HOT PACK COMPRESS TEN COMFORT COLD Presurgical Hot / Cold Pad Infant Heel Warmer

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device