Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009437400

FEI Number

3009437400

Entity Name

JKH Health Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road, Xiagang Community, ChangAn Town, Dongguan Guangdong 523873, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JKH Health Co., Ltd. (Owner Number: 10038935)

Owner / Operator Contact Address

15F, Building 2, Zone 1, Xinqiaodong Advanced Manufacturing Industrial Park, Hongtian Road, Huangpu Community, Xinqiao Street, Baoan District, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POWERED INFLATABLE MASSAGER Mobil-Ize Knee Cryon-X Pro Cryon-X One Cryon-X Cold Compression Ankle wrap Lymphedema Brace Electronic Pulse Stimulator, TENS, TENS garments DVT Air compression Ultrasound TENS Pen TruDVT Compression Therapy Device VenaGo DVT Guardian TruDVT Go TruDVT Slide Cold/Hot Compression Cold Wraps Physical Therapeutic Device System Accessories Cryon-X Accessories Cryon-X Pro Cold Therapy Physical Therapeutic Device System Cryon-X Go Physical Medicine Therapeutic Device System Cryon-X Cryon-X One DVT Cold Compression BigHorn Ice Plus Ice bucket DVT Light Therapy TruLuminate Massager Electronic Pulse Stimulator TENS unit PL-009 Easy@Home TENS Pain Relief Device, EHE009 Easy@Home TENS Pulse Stimulator, EHE010 TM-1000PRO Easy@Home Electronic TENS Pulse Stimulator, EHE012PRO Easy@Home TENS Pulse Stimulator PETENSPAD10 PETENSPAD5 PEPULSE PEPULSE-RT PETENSPAD TENS Electrodes PMS EMS Garments heating Electronic Pulse Stimulator COMPEX TENS/HEAT BACK WRAP KIT COMPEX TENS/HEAT KNEE WRAP KIT PL-029K16B Easy@Home Electronic Pulse Stimulator EHE015BLE Easy@Home TENS Foot Massage Electrode Pads EFM-05R Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads ETP015 Easy@Home Electronic Pulse Stimulator (with MyPainOff (R) Mobile Application) truMedic MicroTENS Thermal MicroTENS Thermal Easy@Home Electronic Pain Relief Stimulator Replacement Pads ETP019 Stimulator TENS Electronic Pulse Stimulator Easy@Home Mini Electronic Pulse Stimulator, EHE029G Parts and accessories of mechano-therapy appliances Mechano-therapy appliances Lymphedema Compression TruEdema TENS PL-029K26-VQ Mediliev RX Electrical Stimulator Pro eStim Electrodes Mediliev Snap Electrode Pads Electrode pads TruEMS Pro eStim PulseStrap EMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2020-09-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-06-03
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-12-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-12-05
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-12-05
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-06-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-09-17
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2024-06-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2015-08-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2015-08-08
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-01-20
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2023-05-05
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2023-05-05
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2020-07-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-07-08
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-01-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-01-19
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2024-01-19
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-01-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-01-11
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2024-06-07
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-06-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2020-09-17
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-12-08
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2011-11-25
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-01-06
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-01-06
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-05-12
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-05-12
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2017-05-12
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2017-05-12
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-11-07
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-10-06
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-05-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-06-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-02-10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2023-02-10
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2023-02-10
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-02-10
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2023-02-10
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2023-02-10
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-02-10

Official Correspondent

Pu Jiang

US Agent Details

BILL QUANQIN DAI Email: Connectdai@hotmail.com Phone: (909) 9299896

Related Public Records

Same Entity

JKH Health Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009437400. Last updated year: 2026. Please use registration number 3009437400 when referencing this establishment in official correspondence.