Cold/Hot Compression

K223541 · Jkh Health Co., Ltd. · IRP · Oct 27, 2023 · Physical Medicine

Device Facts

• Record ID: K223541
• Device Name: Cold/Hot Compression
• Applicant: Jkh Health Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Oct 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

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. Cold/Hot 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 Story

Prescription device combining cold/hot thermal therapy and air compression; treats post-surgical/acute injuries and provides DVT prophylaxis. System comprises main control unit and optional DVT/thermal wraps; wraps applied over clothing to prevent skin irritation. Operates via thermoelectric cooling/heating and pneumatic compression; user-adjustable settings for temperature, pressure, and cycle duration via touch screen. Used in rehabilitation, clinics, athletic settings, or home by professionals or patients under prescription. Provides localized thermal therapy and limb compression to aid blood flow and reduce edema/pain. Battery-powered with 3-year shelf life; stores usage data.

Clinical Evidence

No clinical data; bench testing only. Verification included electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (UI, cooling/heating, pressure, alarms, cycle times, leakage/burst).

Technological Characteristics

Thermoelectric cooling/heating; pneumatic compression; touch screen interface. Power: 100-240 VAC, 50/60 Hz. Materials: Nylon/velvet wraps. Non-sterile. Software-controlled operation. Compliance: ANSI AAMI ES60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring cold, heat, contrast, or compression therapy for post-surgical/acute injuries (edema, swelling, pain) or post-traumatic/post-surgical conditions requiring localized thermal therapy. Also indicated for DVT prophylaxis via lower extremity compression. Intended for use by or on order of licensed healthcare professionals in clinical or home settings.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Predicate Devices

• Therm-X (K193550)

Reference Devices

• NanoTherm and VascuTherm Systems (K061866)

Submission Summary (Full Text)

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October 27, 2023

JKH Health Co., Ltd. Bill Quanqin Dai, Ph.D. Official Correspondent 14271 Jeffrev Rd. #246 Irvine, California 92620

Re: K223541

Trade/Device Name: Cold/Hot Compression Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO, JOW Dated: September 26, 2023 Received: September 28, 2023

Dear Dr. Dai:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Heather L. Dean -S

> Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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# Indications for Use

510(k) Number (if known) K223541

Device Name Cold/Hot Compression

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

### 1. Submitter's Information

Submitter: JKH Health Co., Ltd. Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xinqiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Contact Person: Pu Jiang Tel: [phone] Fax: [phone] Email: [e-mail] Date of Preparation: October 24, 2022

## 2. Subject Device

Trade/Device Name: Cold/Hot Compression Regulation Description: Name: Powered Inflatable Tube Massager; Hot Or Cold, Water Circulating Pack; Compressible Limb Sleeve Regulation Medical Specialty: Physical Medicine, Cardiovascular Review Panel: Physical Medicine, Cardiovascular Product Code: IRP, ILO, JOW Regulation Number: 21 CFR 890.5650, 21 CFR 890.5720, 21 CFR 870.5800 Device Class: II Use: Prescription

## 3. Predicate device

Predicate Device: Therm-X 510(k) Number: K193550 Clearance Date: February 28, 2020 Submitter: Zenith Technical Innovations, LLC

Reference Device: NanoTherm and VascuTherm Systems 510(k) Number: K061866 Clearance Date: August 22, 2006 Submitter: ThermoTek, Inc.

## 4. Description of Subject Device

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.

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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. Please find the detailed storage condition and maintenance in the user manual.

## 5. Indications for 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.

Cold/Hot 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.

#### 6. Summary of Substantial Equivalence

The comparison Table 1 summarizes the detailed comparison between the subject device and the predicate device, indicating the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate device.

| | Subject Device | Predicate Device | Reference Device | Equivalence |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K223541 | K193550 | K061866 | N/A |
| Submitter | JKH Health Co., Ltd. | Zenith Technical Innovations,<br>LLC | ThermoTek, Inc. | N/A |
| Device Name/Model | Cold/Hot Compression | Therm-X | VascuTherm | N/A |
| Indications for Use | Cold/Hot Compression<br>combines cold, heat, contrast,<br>and compression therapy. It is<br>intended to treat post-surgical<br>and acute injuries to reduce<br>edema, swelling, and pain for<br>which cold and compression<br>are indicated. It is intended to<br>treat post traumatic and post-<br>surgical medical and/or<br>surgical conditions for which<br>localized thermal therapy (hot<br>or cold) are indicated.<br>Cold/Hot Compression also<br>provide DVT therapy. It is<br>intended to reduce the risk of<br>the formation of deep venous<br>thrombosis (DVT) by aiding<br>blood flow back to the heart via<br>lower extremity limb<br>compression.<br>Cold/Hot Compression is<br>intended to be used by, or on | Therm-X (Therm-X Home and<br>Therm-X AT) combines cold,<br>heat, contrast, and compression<br>therapy. Therm-X is intended<br>to treat post-surgical and acute<br>injuries to reduce edema,<br>swelling, and pain for which<br>cold and compression are<br>indicated. It is intended to treat<br>post traumatic and post-<br>surgical medical and/or<br>surgical conditions for which<br>localized thermal therapy (hot<br>or cold) are indicated.<br>Therm-X Home systems also<br>provide DVT therapy. Therm-<br>X Home systems with DVT<br>therapy are intended to reduce<br>the risk of the formation of<br>deep venous thrombosis (DVT)<br>by aiding blood flow back to<br>the heart via lower extremity<br>limb compression. | Treatment of disorders<br>associated with vascular or<br>lymphatic insufficiency such as<br>Chronic Venous Insufficiency<br>(CVI), venous stasis ulcers,<br>post-mastectomy edema and<br>chronic lymphedema.<br>Reduction of edema associated<br>with soft tissue injuries such as<br>bums, postoperative edema,<br>and ligament sprains.<br>Localized thermal therapy (hot<br>or cold) for post traumatic and<br>post surgical medical and/or<br>surgical conditions.<br>Decrease the risk of deep<br>venous thrombosis (DVT).<br>Aids the blood flow back to the<br>heart. | Identical |
| | the order of, licensed health<br>care professionals in<br>rehabilitation facilities,<br>outpatient clinics, athletic<br>training settings, and home<br>settings. | Therm-X (Therm-X Home and<br>Therm-X AT) is intended to be<br>used by, or on the order of,<br>licensed health care<br>professionals in rehabilitation<br>facilities, outpatient clinics,<br>athletic training settings, and<br>home settings. | Treat and assist healing of<br>cutaneous ulceration (wounds),<br>reduce would healing time,<br>enhance arterial circulation<br>(blood flow), reduce<br>compartmental pressures,<br>reduce edema (swelling),<br>reduce the need for<br>anticoagulant (blood thinning)<br>medications. | |
| Intended Users | Health Care Professionals and<br>lay users (under prescription) | Health Care Professionals and<br>lay users (under prescription) | Health Care Professionals and<br>lay users (under prescription) | Identical |
| Prescription or OTC | Prescription | Prescription | Prescription | Identical |
| Power Source(s) | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Identical |
| Compliance with<br>Voluntary Standards? | Yes | Yes | Yes | Identical |
| Electrical Safety<br>Mechanical Safety<br>Chemical Safety<br>Thermal Safety<br>Radiation Safety? | Yes | Yes | Yes | Identical |
| Cold Therapy | Default: 50°F<br>Custom: 41°F-55°F<br>Default, continuous: 50°F<br>Custom, continuous: 41°F - 50°F | Default: 34°F, 45°F, 55°F<br>Custom: 34°F - 55°F<br>Default, continuous: 40°F, 45°F,<br>50°F<br>Custom, continuous: 40°F - 50°F | Default: 49°F<br>Custom: 43°F-49°F<br>Default, continuous: 49°F<br>Custom, continuous: 43°F - 49°F | Equivalent Note 1 |
| Heat Therapy | Default: 105°F<br>Custom: 105°F-109°F<br>Default, continuous: 105°F<br>Custom, continuous: 105°F -<br>109°F | Default: 105°F, 107°F, 110°F<br>Custom: 105°F -110°F<br>Default, continuous: 105°F, 107°F<br>Custom, continuous: 105°F -<br>107°F | Default: 105°F<br>Custom: 100°F-105°F<br>Default, continuous: 105°F<br>Custom, continuous: 100°F -<br>105°F | Equivalent Note 2 |
| Edema Pressure<br>Levels | Compression Therapy Alternate<br>mode: 15 -75 mm Hg<br>Compression Therapy Continuous<br>mode: 15 -75 mm Hg | Available in four levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous treatment,<br>available in three levels:<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Compression Therapy 3 Settings:<br>Low (15 mm Hg)<br>Medium (30 mm Hg)<br>High (50 mm Hg) | Equivalent Note 3 |
| Static or Intermittent<br>Pressure | Both | Both | Intermittent Pressure available | Identical |
| DVT Only | Available | Available for Therm-X Home<br>Model | Available | Identical |
| DVT Pressure | Calf: 55 mmHg<br>Foot: 130 mmHg | Calf: 50-70 mmHg<br>Foot: 90 - 130 mmHg | Calf: 45 mmHg<br>Foot: 100 mmHg | Equivalent Note 4 |
| Cycle Length (for<br>Heat, Cold, And<br>Compression) | Default: 30 minutes<br>Custom: 1 - 60 minutes | Default: 10 or 20 minutes<br>Custom: 3 - 40 minutes<br>Continuous: 10-40 minutes<br>active, 30-60 minutes rest | Default: 90 minutes | Equivalent Note 5 |
| Contrast Therapy | Heat: 105°F<br>Cold: 49°F | Heat: 105°F<br>Cold: 38°F | Heat: 105°F<br>Cold: 49°F | Equivalent Note 6 |
| Cycle Length (for<br>Contrast Therapy) | Heat: 10 minutes<br>Cold: 20 minutes | Heat: 3-10 minutes<br>Cold: 3-10 minutes<br>Total treatment: 6-60 minutes | Heat: 10 minutes<br>Cold: 20 minutes | Equivalent Note 7 |
| DVT Cycle Length | No specified time interval. DVT<br>can be stopped at any time by the<br>user. | No specified time interval. DVT<br>can be stopped at any time by the<br>user. | No specified time interval. DVT<br>can be stopped at any time by the<br>user. | Identical |
| Edema Compression<br>and DVT Compression<br>at the same time | Available<br>Edema Compression must be<br>combined with cold, heat, or<br>contrast therapy | Available<br>Edema Compression (Lite, Low,<br>Medium, High) must be | Available<br>Edema Compression (Lite, Low,<br>Medium, High) must be | Identical |
| | | combined with cold, heat, or<br>contrast therapy | combined with cold, heat, or<br>contrast therapy | |
| Inflation and Deflation | Inflation: Up to 120 seconds<br>Deflation: Up to 30 seconds | Inflation: Up to 120 seconds<br>Deflation: Up to 30 seconds | Inflation: Up to 120 seconds<br>Deflation: Up to 30 seconds | Identical |
| Store Cycle Usage<br>Data | Available | Available | Available | Identical |
| Chilling Mechanism | Thermoelectric | Thermoelectric | Thermoelectric | Identical |
| Heating Mechanism | Thermoelectric | Thermoelectric | Thermoelectric | Identical |
| Reservoir Fluid<br>Capacity | 350 mL | 650 mL | 300mL | Equivalent Note 8 |
| Recommended<br>Coolant | 90% Distilled Water,<br>10% Isopropyl Alcohol | 90% Distilled Water,<br>10% Isopropyl Alcohol | 90% Distilled Water,<br>10% Isopropyl Alcohol | Identical |
| User Interface | Touch Screen…