JKH Health Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 22 device types, 2 products catalogued, 10 clearances.
JKH Health Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sling, Arm, Orthosis, Lumbar and 20 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
22device types registered with the FDA
2products catalogued under its own name
10510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009437400 |
| FEI number | 3009437400 |
| DUNS | 526876993 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 3-5F and 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road |
| Postal code | 523873 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Joint, Ankle, External Brace | Class 1 | Ankle wrap | 2024 | 134 |
| Joint, Hip, External Brace | Class 1 | External Brace | 2024 | 33 |
| Joint, Knee, External Brace | Class 1 | Mobil-Ize Knee | 2023 | 137 |
| Joint, Shoulder, External Limb Component | Class 1 | Brace | 2024 | 20 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | TruLuminate, Light Therapy | 2025 | 235 |
| Massager, Powered Inflatable Tube | Class 2 | Cryon-X One, Cryon-X Pro, Cryon-X Cold Compression, BigHorn Ice Plus, Cold Compression, Ice bucket and 17 more | 2020 | 37 |
| Massager, Therapeutic, Electric | Class 1 | Massager | 2011 | 437 |
| Media, Coupling, Ultrasound | Class 2 | Ultrasound Gel | 2023 | 8 |
| Orthosis, Lumbar | Class 1 | TruBack | 2023 | 110 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | Hot Or Cold Therapy, BigHorn Ice, Cryon-X One, Cryon-X Pro, Cryon-X Cold Compression, BigHorn Ice Plus and 11 more | 2023 | 45 |
| Pad, Heating, Powered | Class 2 | Easy@Home TENS Electrode Pads, ETP018, Easy@Home Heat TENS Unit, EHE018, PL-029Q, Transcutaneous Electrical Nerve Stimulator, Heating pad, PulseStrap and 24 more | 2017 | 144 |
| Sleeve, Limb, Compressible | Class 2 | DVT, Mechano-therapy appliances, Parts and accessories of mechano-therapy appliances, Cryon-X One, Cryon-X Pro, Cryon-X Cold Compression and 19 more | 2018 | 24 |
| Sling, Arm | Class 1 | Sling | 2024 | 126 |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | Class 2 | TruRecovery, Echo Rx, Ultrasound Stimulator, Ultrasound | 2023 | 2 |
| Stimulator, Bone Growth, Non-Invasive | Class 2 | Bone Growth Stimulator, ManaFuse | 2025 | 1 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | TENS Pen, Easy@Home TENS Electrode Pads, ETP018, Easy@Home Heat TENS Unit, EHE018, PL-029Q, Transcutaneous Electrical Nerve Stimulator, PulseStrap and 37 more | 2016 | 22 |
| Stimulator, Muscle, Powered | Class 2 | PulseStrap, TruEMS, Mediliev RX Electrical Stimulator, Pro eStim, Tens, PL-029K26-VQ and 4 more | 2023 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Easy@Home TENS Electrode Pads, ETP018, Easy@Home Heat TENS Unit, EHE018, PL-029Q, Transcutaneous Electrical Nerve Stimulator, Electronic Pulse Stimulator, TENS, TENS garments, PulseStrap and 49 more | 2014 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | PulseStrap, TruEMS, Mediliev RX Electrical Stimulator, Pro eStim, Tens, PL-029K26-VQ and 4 more | 2023 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | TENS Pen, Easy@Home TENS Electrode Pads, ETP018, Easy@Home Heat TENS Unit, EHE018, PL-029Q, Transcutaneous Electrical Nerve Stimulator, Electronic Pulse Stimulator, TENS, TENS garments and 52 more | 2014 | 57 |
| Stimulator, Neuromuscular, External Functional | Class 2 | PulseStrap, TruEMS, Mediliev RX Electrical Stimulator, Pro eStim, Tens, PL-029K26-VQ and 4 more | 2023 | 8 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Class 2 | TruRecovery, Echo Rx, Ultrasound Stimulator, Ultrasound | 2023 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Shenzhen Jingkehui Electronic | NUH | 1 |
| Medi-Direct Tens Pen | NUH | 1 |
Clearances
10 clearances name JKH Health Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253150 | 2025-10-24 | IRP | Special | This company |
| K240788 | 2025-06-04 | IMI | Traditional | This company |
| K240986 | 2024-05-01 | IRP | Special | This company |
| K240011 | 2024-02-23 | JOW | Traditional | This company |
| K223541 | 2023-10-27 | IRP | Traditional | This company |
| K211050 | 2022-11-28 | FLL | Traditional | This company |
| K202839 | 2021-01-21 | JOW | Traditional | This company |
| K200561 | 2020-07-01 | NUH | Special | This company |
| K162517 | 2017-04-14 | NUH | Traditional | This company |
| K153520 | 2016-05-05 | NUH | Traditional | This company |
| K221999 | 2022-08-30 | MUI | Traditional | Hony Medical Co., Ltd. |
| K201645 | 2020-09-15 | IRP | Traditional | Jkh USA, LLC |
| K193020 | 2019-12-04 | JOW | Special | Innovamed Health, LLC |
| K150995 | 2015-07-06 | NUH | Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. |
| K141260 | 2014-09-17 | NUH | Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. |
| K131921 | 2013-11-15 | NUH | Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | TENS units, EMS devices, Healthcare products |
|---|---|
| Certifications | FDA 510(k), ISO13485, Medical CE, Health Canada, MDSAP |
| Export markets | Global, Amazon bestsellers |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.