FDA.reportPublic FDA data

Wello, Inc

Primary DI
00860011348603
Brand
Wello, Inc
Company
Wello, Inc
Model
welloStationX
Device description
The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 - 70% RH non-condensing.
Published
2024-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180298000welloStationXWello, Inc.2018-11-30FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011348603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011348603008600113486038600113486030860011348603

GMDN Terms#

Term, Definition table
TermDefinition
Body temperature screening thermometer stationA freestanding electrically-powered unit designed for contactless measurement of temperature on the forehead/face of a person for screening purposes (e.g., to detect those with a fever). It may be a benchtop device or intended for attachment to a floor mount, and consists of a built-in infrared thermometer, integrated camera, face detection software, and image display screen to help adequate positioning of a person’s face during measurement; it may include a printer for labelling/identification of personnel/patients. It is typically used within healthcare facilities, public or work environments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117825202
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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