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JKH Health Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 15 510(k) clearances

JKH Health Co., Ltd. is registered with the FDA (registration 3009437400) in Dongguan Guangdong, China. It lists 22 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 24, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch JKH Health Co., Ltd.
FDA registration number
3009437400
Address
3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road Xiagang Community, ChangAn Town, Dongguan Guangdong, China, 523873
Owner or operator
JKH Health Co., Ltd. (10038935)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
November 25, 2011
Registered through
2026
Brand names listed
Air Compression Leg Massagers, Air compression, Ankle wrap, BigHorn Ice, BigHorn Ice Plus, Bone Growth Stimulator, Brace, COMPEX TENS/HEAT BACK WRAP KIT and more

Devices it lists

DeviceProduct codeClassRoleSource
Joint, Ankle, External BraceITW1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Hip, External BraceITS1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Shoulder, External Limb ComponentIQQ1Exporter to the US, Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Manufactureraccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Manufactureraccessdata.fda.gov
Media, Coupling, UltrasoundMUI2Exporter to the USaccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the US, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Contract manufacturer, Manufactureraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Contract manufacturer, Manufactureraccessdata.fda.gov
Sling, ArmILI1Exporter to the US, Manufactureraccessdata.fda.gov
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep HeatPFW2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Bone Growth, Non-InvasiveLOF2Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Contract manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Contract manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Neuromuscular, External FunctionalGZI2Contract manufactureraccessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatIMI2Contract manufacturer, Manufactureraccessdata.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
October 24, 2025K253150Cryon-X Cold CompressionIRPSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
June 4, 2025K240788Ultrasound StimulatorIMISubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
May 1, 2024K240986Cold CompressionIRPSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
February 23, 2024K240011Lymphedema CompressionJOWSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
October 27, 2023K223541Cold/Hot CompressionIRPSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
August 30, 2022K221999Ultrasound Transmission GelsMUISubstantially EquivalentHony Medical Co., Ltd.accessdata.fda.gov
January 21, 2021K202839Overlapped Compression TherapyJOWSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
September 15, 2020K201645Massage Compression BootsIRPSubstantially EquivalentJkh USA, LLCaccessdata.fda.gov
July 1, 2020K200561StimPlus Patch, StimPlus Patch, StimPlus PatchNUHSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
December 4, 2019K193020VenaPro Vascular Therapy SystemJOWSubstantially EquivalentInnovamed Health, LLCaccessdata.fda.gov
April 14, 2017K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUHSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
May 5, 2016K153520Electronic Pulse StimulatorNUHSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
July 6, 2015K150995Electronic Pulse StimulatorNUHSubstantially EquivalentShenzhen Jingkehui Electronic Co.., Ltd.accessdata.fda.gov
September 17, 2014K141260ELECTRONIC PULSE STIMULATORNUHSubstantially EquivalentShenzhen Jingkehui Electronic Co.., Ltd.accessdata.fda.gov
November 15, 2013K131921ELECTRONIC PULSE STIMULATORNUHSubstantially EquivalentShenzhen Jingkehui Electronic Co.., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 24, 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.