CHOSEN Infrared Forehead Thermometer

FDA UDI

Class II (US FDA UDI)

by ABOUND Diagnostics, Inc

Identity

Trade Name: CHOSEN Infrared Forehead Thermometer FDA UDI
Generic Name: Infrared patient thermometer, ear/skin FDA UDI
Device Name: CHOSEN Infrared Forehead Thermometer FDA UDI
Model / Reference: FTH800 FDA UDI
Description: CHOSEN Infrared Forehead Thermometer FDA UDI

Identifiers

Catalog Number: FTH800 FDA UDI
Primary DI / UDI-DI: 00840423500202 FDA UDI
510(k) Number: K190984 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Infrared patient thermometer, ear/skin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Infrared patient thermometer, ear/skin

CHOSEN Infrared Forehead Thermometer by ABOUND Diagnostics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, ear/skin.

huangirl Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
FIGHTECH — Shenzhen Urion Technology Co., Ltd. · Class II
Infrared Thermometer — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II
Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
MOBI — MOBI TECHNOLOGIES, INC. · Class II
CONAIR CORPORATION — CONAIR LLC. · Class II
AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
Caroune — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II

Cleared under the same submission

K190984 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: ABOUND Diagnostics, Inc

Sources (1)

FDA UDI 620428cb-5612-41ed-ba84-eb9faa2f0167 36 fields · synced May 30, 2026