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510(k) Data Aggregation
K Number
K240788Device Name
Ultrasound Stimulator
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2025-06-04
(439 days)
Product Code
IMI, PFW
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
JKH Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
4. Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
5. Localized increase in blood flow.
6. Increased range of motion of contracted joint using heat and stretch techniques.
Device Description
As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.
It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.
The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.
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K Number
K240986Device Name
Cold Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2024-05-01
(21 days)
Product Code
IRP, ILO
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
JKH Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
Device Description
The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.
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K Number
K240011Device Name
Lymphedema Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2024-02-23
(52 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
JKH Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- Treatment of lymphedema
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
Device Description
As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.
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K Number
K223541Device Name
Cold/Hot Compression
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2023-10-27
(336 days)
Product Code
IRP, ILO, JOW
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
JKH Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cold/Hot Compression combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
ColdHot Compression is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Device Description
The subject device is a prescriptive device, which combines cold/hot therapy and air compression. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
The subject device comes with the thermal-therapy wraps and the DVT wraps. The thermal-therapy wrap is nylon fabric on one side and velvet cloth on the other side; the DVT wrap is velvet on both sides. To avoid any potential adverse skin reactions such as redness, irritation, and cold/hot injury, the sock/clothing should be worn by the patient prior to use.
The subject device includes a main device and an optional DVT device, and has a limited shelf life of 3 years, based on the charge retention characteristics of the device's battery.
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K Number
K211050Device Name
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
Manufacturer
JKH HEALTH CO., LTD.
Date Cleared
2022-11-28
(599 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
JKH HEALTH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer is intended temperature measurement at home or hospital for people of all ages without contact to human body.
Device Description
Not Found
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K Number
K202839Device Name
Overlapped Compression Therapy
Manufacturer
JKH HEALTH CO., LTD.
Date Cleared
2021-01-21
(118 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
JKH HEALTH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compression Therapy Device is intended to be an easy to use portable by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation;
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
- · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Device Description
Compression Therapy Device
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K Number
K162517Device Name
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
Manufacturer
JKH Health Co., Ltd.
Date Cleared
2017-04-14
(217 days)
Product Code
NUH, IRT, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
JKH Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Modes 1, 2, 4, 5, 6, 8)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (also called EMS, Modes 1, 3, 7)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating Mode Temporary relief of minor aches and pains.
Device Description
Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 °C.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode pads and electrode garments, which could be packaged separately and/or together with the subject device.
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