JKH Health Co., Ltd.
Dongguan Guangdong, CN
JKH Health Co., Ltd. appears in FDA device records in Dongguan Guangdong, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for JKH Health Co., Ltd. between 2016 and 2025. The busiest year on record is 2024, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253150 | Cryon-X Cold Compression | IRP | Substantially Equivalent | |
| K240788 | Ultrasound Stimulator | IMI | Substantially Equivalent | |
| K240986 | Cold Compression | IRP | Substantially Equivalent | |
| K240011 | Lymphedema Compression | JOW | Substantially Equivalent | |
| K223541 | Cold/Hot Compression | IRP | Substantially Equivalent | |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | FLL | Substantially Equivalent | |
| K202839 | Overlapped Compression Therapy | JOW | Substantially Equivalent | |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | NUH | Substantially Equivalent | |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | NUH | Substantially Equivalent | |
| K153520 | Electronic Pulse Stimulator | NUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009437400 | 3009437400 | JKH Health Co., Ltd. | 3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road, Dongguan Guangdong 523873 CN | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FLLContinuous Measurement Thermometer
- ITWJoint, Ankle, External Brace
- ITSJoint, Hip, External Brace
- ITQJoint, Knee, External Brace
- IQQJoint, Shoulder, External Limb Component
- ILYLamp, Infrared, Therapeutic Heating
- IRPMassager, Powered Inflatable Tube
- ISAMassager, Therapeutic, Electric
- MUIMedia, Coupling, Ultrasound
- IQEOrthosis, Lumbar
- ILOPack, Hot Or Cold, Water Circulating
- IRTPad, Heating, Powered
- JOWSleeve, Limb, Compressible
- ILISling, Arm
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- LOFStimulator, Bone Growth, Non-Invasive
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- GZIStimulator, Neuromuscular, External Functional
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain