BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Wellell Inc.

    Reg #: 8043439 · FEI: 3004411059 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    74
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    Wellell Inc.
    Registration Number
    8043439
    FEI Number
    3004411059
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 9, MIN SHENG ST., TU-CHENG
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K193206

    Owner / Operator

    Firm Name
    Wellell Inc.
    Operator Number
    9001426
    Address
    No. 9, MIN SHENG ST., TU-CHENG,
    City
    NEW TAIPEI CITY
    State
    TW-TPE
    Postal Code
    236044
    Country
    TW
    Correspondent
    Chieh - Yang

    US Agent

    Business Name
    WELLELL AMERICA CORP.
    Contact Name
    Elsa Chu
    Address
    927 Mariner Street, Brea, CA 92821, USA
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    714 6713818

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD
    Nebulizer (Direct Patient Interface) CAF
    Sleeve, Limb, Compressible JOW
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Cushion, Flotation KIC
    Mattress, Air Flotation, Alternating Pressure FNM
    Bed, Flotation Therapy, Powered IOQ

    Proprietary Names

    WiZARD 510 Nasal Mask M Size WiZARD 510 Nasal Mask L Size WiZARD 510 Nasal Mask( M/L) SM00018, M Nasal Pillows Cushion SM00023, Headgear Set, Lavender SM00020, XS Nasal Pillows Cushion SM00022, Elbow Connector with Short Tube SM00017, L Nasal Pillows Cushion SM00024, Headgear Set, Light Blue SM00021, Mask Frame SM03001, Mr. WiZARD 230 Nasal Pillows Mask with Headgear SM00019, S Nasal Pillows Cushion WiZARD 310 Nasal Mask WiZARD 320 Full Face Mask WiZARD 320 Full Face Mask(S/M/L) WiZARD 310 Nasal Mask(S/M/L) WiZARD 310 Nasal Mask(S) WiZARD 310 Nasal Mask(M) WiZARD 320 Full Face Mask(S) WiZARD 320 Full Face Mask(L) WiZARD 320 Full Face Mask(M) iCH Auto Mini Star Minicare VenAir, Sequential Compression System XT Heated Humidifier (9S-006500) WiZARD 210 Nasal Mask (XS) (SM01011) WiZARD 210 Nasal Mask (M) (SM01009) WiZARD 220 Full Face Mask (L) (SM02010) WiZARD 220 Full Face Mask (S) (SM02012) WiZARD 210 Nasal Mask (L) (SM01008) WiZARD 220 Full Face Mask (M) (SM02011) WiZARD 210 Nasal Mask (S) (SM01010) SM00005, WiZARD 220 Full Face Mask Cushion, M SM00016, Small Silicon Tubing SM00006, WiZARD 220 Full Face Mask Cushion, S SM00003, WiZARD 210 Nasal Mask Cushin, S SM00030, WiZARD 210 Nasal Mask Cushin, XS SM00001, WiZARD 210 Nasal Mask Cushin, L SM00004, WiZARD 220 Full Face Mask Cushion, L SM00002, WiZARD 210 Nasal Mask Cushin, M Procare Auto G3 Seat cushion Sedens 500 ACS Series Pump and Mattress SERENE Series Pump and Mattress Serene Bariatric Optima Auto Optima Prone Optima Turn PRO-CARE Series Pump and Mattress DOMUS 3 Pump and Mattress DOMUS Auto Pump and Mattress Sedens 400 DOMUS 2S Pump and Mattress Procare Elite Procare Auto Link G3 Domus ECO Domus 1 G2 Procare Auto G2 DOMUS 1 Pump and Mattress Domus Auto G2 Domus Bariatric G2 DOMUS 4 Pump and Mattress Domus 3D Serene Elite Serene Air Domus 4 G2 Pump Procare Bariatric G2 Procare Auto G3 Domus 2 G2 Sedens 500 SE Crossover Nio WiZARD 520 Full Face Mask XT Auto (9S-005720)

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)