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Data / Medical devices / Hong Kong / Warrenslove(hongkong)limited

Warrenslove(hongkong)limited: FDA-registered device maker in Kowloon, Hong Kong, 10 510(k) clearances

Warrenslove(hongkong)limited is registered with the FDA (registration 3033530347) in Kowloon, Hong Kong. It lists 14 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 14, 2025. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Warrenslove(hongkong)limited
FDA registration number
3033530347
Address
RMS 1318-19, 13/F Hollywoodplaza 610 Nathan RD Mongkok, Kowloon, Hong Kong, 999077
Owner or operator
WARRENSLOVE(HONGKONG)LIMITED (10091713)
Roles
Exporter to the US, Manufacturer
First device listed
October 27, 2024
Registered through
2026
Brand names listed
A06, A081, AD812, AD815, ANK-A28, BP-2BIO, BSY269, Digital Ovulation Test Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Exporter to the USaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Laser, Comb, HairOAP2Exporter to the USaccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Oximeter, WellnessPGJ2Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Exporter to the USaccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Exporter to the USaccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 14, 2025K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)FLLSubstantially EquivalentShenzhen Finicare Co., Ltd.accessdata.fda.gov
November 27, 2023K230379Portable (Ultrasonic) NebulizerCAFSubstantially EquivalentDongguan Simzo Electronic Technology Co., Ltd.accessdata.fda.gov
February 28, 2023K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
August 12, 2022K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring SystemNBWSubstantially EquivalentBioland Technology, Ltd.accessdata.fda.gov
May 31, 2022K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)DXNSubstantially EquivalentShenzhen Finicare Co., Ltd.accessdata.fda.gov
May 6, 2022K213788TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)NUHSubstantially EquivalentDongguan Bohuikang Technology Co.,Ltdaccessdata.fda.gov
February 19, 2022K212935Air Pressure Foot MassagerIRPSubstantially EquivalentXiamen Simo Electronic Co., Ltd.accessdata.fda.gov
June 17, 2021K210281Fist Assist Devices Model FA-1IRPSubstantially EquivalentFist Assist Devices, LLCaccessdata.fda.gov
April 16, 2021K210169Hair Growth DeviceOAPSubstantially EquivalentDongguan Lescolton Intelligent Electrical Appliance Co., Ltd.accessdata.fda.gov
February 14, 2013K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.