Kaz USA, Inc., A Helen of Troy Company

FDA Device Registration & Listing · MARLBOROUGH, MA, US · Registration 3006169981

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006169981
FEI Number
3006169981
Entity Name
Kaz USA, Inc., A Helen of Troy Company
City/State/Country
MARLBOROUGH, MA, US
Establishment Address
400 Donald Lynch Blvd Ste 300, MARLBOROUGH, MA 01752, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Kaz USA, Inc., A Helen of Troy Company (Owner Number: 1314800)
Owner / Operator Contact Address
400 Donald Lynch Boulevard, Suite 300, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Dunlap Soft Heat Bruder BRAUN ExactFit™ 1 Upper arm blood pressure monitor Braun Infrared Forehead Thermometer Braun Braun ThermoScan Braun ThermoScan 4 Ear Thermometer BRAUN ThermoScan 4+ connect Ear thermometer Braun ThermoScan Lens Filters LF40 and LF20 Hantech Probe Cover LF40 and LF20 Vicks Braun Thermoscan Braun Smart Temp Mind + Body Care Vicks SoftHest Braun Thermoscan Vicks Braun Thermoscan PRO 4000 series Braun Thermoscan IRT 4000 series Braun Thermoscan Vicks Braun Thermometer Vicks® SmartTemp™ Thermometer Braun® Nasal Aspirator Vicks Underarm Thermometer Vicks Braun Thermoscan SoftHeat Braun ThermoScan 3 High Speed Compact Ear Thermometer Braun Nasal Aspirator Filters Braun manual nasal aspirator BRAUN EXACTFIT 3 UPPER ARM BLOOD PRESSURE MONITOR BRAUN VICKS NON CONTACT INFRARED BODY THERMOMETER Therasteam Personal Steam Inhaler QuietCare® Cool Moisture Humidifier Easy to Care Top Fill Warm Mist Humidifier Top Fill Ultrasonic Humidifier Filter Free Cool Moisture Humidifier Ultrasonic Cool Mist Humidifier Warm Mist Humidifier UltraViolet Germ-Free Humidification UltraViolet Germ-Free Cool Moisture Humidifier Top Fill Warm Mist Humidifier MistMate™ Cool Mist Humidifier Easy to Care Filter Free Humidifier Cool Moisture Humidifier Filter Free Cool Mist Humidifier UltraViolet Germ-Free Cool Mist Humidifier Easy to Care Top Fill Cool Moisture Humidifier CVS Health Warm Mist Humidifier Rite Aid Ultasonic Cool Mist Humidifier Honeywell Easy to Care Cool Moisture Humidifier Vicks NaturalCare Humidifier Diffuser VapoPads Nitetime-Light CVS Health Cool Mist Humidifier Honeywell Easy to Care Cool Mist Humidifier CVS Health Warm Steam Vaporizer Vicks Mini FilterFree Cool Mist Humidifier Vicks 3-in-1 SleepyTime Humidifier Honeywell Reflection Cool Mist Filter Free Humidifier Braun Vicks Braun TempleSwipe Thermometer Vicks, Instant Digital Electric Thermometer Vick ComfortFlex Thermometer Vicks Digital Thermometer Braun Digital Thermometer Vicks Cordless Steam Inhaler Kaz Walgreens Protec Vicks CVS ProCare Rite Aid Walgreens Cool Mist Humidifier FilterFree Plus Cool Mist Humidifier Vicks Warm Mist Humidifier Vicks Embrace Cool Mist Filter Free Humidifier Honeywell Dual Comfort Humidifier Vicks Dual Comfort Cool + Warm Filter Free Humidifier Vicks FilterFree Cool Mist Humidifier CVS Health Warm Mist Humidifier CVS Health Steam Inhaler Vicks VapoPads Refill Pads Vicks VapoPads PLUS Vicks VapoPads Refills Vicks VapoPads CVS Health Inhalant Pad Refills HONEYWELL Vicks VapoPads SINUS Vicks Filtered Cool Mist Humidifier Vicks Sleepy Time Vapopads Vicks Sinus Steam Inhaler Vicks VapoPads Calming Vapors Vicks RapidRead Digital Thermometer VICKS NO TOUCH THERMOMETER BRAUN NO TOUCH THERMOMETER Braun Braun Precision Sensor Welch Allyn Braun Probe Covers Thermometer Braun ThermoScan® 7+ connect Ear Thermometer Braun ThermoScan Infrared Ear Thermometer Infrared Ear Thermometer Braun ThermoScan Lens Filters Vicks Pacifier Vicks Braun Thermoscan Braun Precision Sensor Braun Pulse Oximeter BPX801US

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 1992-06-24
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2021-12-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-07-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-01-06
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2008-09-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-01-04
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-06-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-11-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-04-28
KMA Irrigator, Powered Nasal Ear, Nose, Throat Class 1 874.5550 2018-09-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-04-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2011-08-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-12
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-06-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-03-26
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2007-11-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-08-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-12-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-11-18
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2006-03-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-08-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-05-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-02-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-07-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-06-17
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2026-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kaz USA, Inc., A Helen of Troy Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010405299 Kaz USA, Inc., A Helen of Troy Company Olive Branch, MS, US
3004871905 Helen of Troy Macao Limited Macau Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13
K903633 Transonic Systems, Inc. ADVANCE LASER FLOWMETER, ALF 21 1990-10-09
K182494 Laser Associated Sciences, Inc. FlowMet-R 2019-02-27
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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3013284090 SHENZHEN H&T INTELLIGENT CONTROL CO., LTD. Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006169981. Last updated year: 2026. Please use registration number 3006169981 when referencing this establishment in official correspondence.
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