FDA Registration
Active
🇨🇳 China
JKH Health Co., Ltd.
Reg #: 3009437400
·
FEI: 3009437400
·
Expires 2026
Products
22
Proprietary Names
113
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- JKH Health Co., Ltd.
- Registration Number
- 3009437400
- FEI Number
- 3009437400
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road, Xiagang Community, ChangAn Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253150
Owner / Operator
- Firm Name
- JKH Health Co., Ltd.
- Operator Number
- 10038935
- Address
- 15F, Building 2, Zone 1, Xinqiaodong Advanced Manufacturing Industrial Park, Hongtian Road, Huangpu Community, Xinqiao Street, Baoan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518125
- Country
- CN
- Correspondent
- Pu Jiang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2020-09-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2023-06-03 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2025-12-05 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-12-05 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-06-07 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2024-06-07 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2015-08-08 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2015-08-08 |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | Class 2 | Physical Medicine | No | 2023-05-05 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2023-05-05 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2020-07-08 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-12-08 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2011-11-25 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2017-05-12 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-02-10 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2023-02-10 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2023-02-10 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2024-06-07 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-06-03 |
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 2 | Orthopedic | No | 2025-02-26 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2023-09-25 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-06-07 |
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
Cold Therapy
Physical Therapeutic Device System
Cryon-X Go
Physical Medicine Therapeutic Device System
Cryon-X
Cold Compression
BigHorn Ice Plus
Ice bucket
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
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
Easy@Home Mini Electronic Pulse Stimulator, EHE029G
Parts and accessories of mechano-therapy appliances
Mechano-therapy appliances
Lymphedema Compression
TruEdema
PL-029K26-VQ
Mediliev RX Electrical Stimulator
Pro eStim Electrodes
Mediliev Snap Electrode Pads
Electrode pads
TruEMS
Pro eStim
PulseStrap
PL-029K9
PL-029K8
PL-029K5
FlexAbs
FlexTone
FlexBody
FlexTone FlexBody
FlexTone FlexAbs
Electronic Pulse Stimulator, also called FlexTone FlexAbs and FlexBody
Easy@Home Mini Wireless TENS Pulse Stimulator EHE015
Easy@Home Electronic Pain Relief Stimulator EHE019
PL-029K8-P2
PL-029K8-P1
Transcutaneous Electrical Nerve Stimulator
Easy@Home TENS Electrode Pads, ETP018
Easy@Home Heat TENS Unit, EHE018
PL-029Q
EXTERNAL BRACE
Massage Compression Boots
Leg Massager
JKH-102C
Air Compression Leg Massagers
Compression Therapy Massager
Novonergy Air Compression Leg Massager
JKH-102D
Hot Or Cold Therapy
BigHorn Ice
TruBack
Bone Growth Stimulator
ManaFuse
TruRecovery
Echo Rx
Ultrasound Stimulator
Ultrasound Gel
SLING
Heating pad
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device