K Number

Device Name

Cold Compression

Manufacturer

JKH Health Co., Ltd.

Date Cleared

2024-05-01

(21 days)

Product Code

IRP ILO

Regulation Number

890.5650

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K223541, K183702

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that provides cold and compression therapy with user-adjustable settings. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes.
The device is intended to treat medical conditions (reduce edema, swelling, and pain post-surgical and acute injuries), which aligns with the definition of a therapeutic device.

Diagnostic

Explanation: The device description states its purpose is to "treat post-surgical and acute injuries to reduce edema, swelling, and pain," and it features "cold therapy and compression therapy." It does not mention any function for analyzing or interpreting patient data to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "AC powered, software-controlled multimodality device" and details physical components like a bucket body, lid, buttons, and connecting tubes, indicating it is a hardware device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The described device provides cold and compression therapy applied externally to the body to treat injuries and reduce symptoms like edema, swelling, and pain. It does not analyze any biological samples.
Intended Use: The intended use clearly states it's for treating post-surgical and acute injuries by applying cold and compression, not for diagnostic purposes based on analyzing samples.

Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

IRP, ILO

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

universal, back, shoulder, ankle/foot, hip, and knee (based on available wraps)

Indicated Patient Age Range

Adult; children and the elderly should only use the product under direct supervision of a medical professional

Intended User / Care Setting

licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were performed on the subject device in validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
Clinical testing was not needed in support of this 510(k) application.
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K223541, K183702

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 1, 2024

JKH Health Co., Ltd. % Bill Quanqin Dai Managing Member JKH USA LLC 14271 Jeffrey Road #246 Irvine, CA 92620

Re: K240986

Trade/Device Name: Cold Compression Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP. ILO Dated: February 22, 2024 Received: April 10, 2024

Dear Bill 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).

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tushar Bansal -S

for 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

Enclosure

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240986

Device Name

Cold Compression

Indications for Use (Describe)

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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

1. Submitter's Information

JKH Health Co., Ltd. Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xinqiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Tel: +86-755-27926589 Fax: +86-755-27926585 E-mail: sales@JKHhealth.com Date of Preparation: 4/09/2024

2. Subject Device

Trade/Device Name: Cold Compression Common Name: Powered Inflatable Tube Massager; Hot or Cold, Water Circulating Pack Regulation Medical Specialty: Physical Medicine Review Panel: Physical Medicine Product Code: IRP, ILO Regulation Number: 21 CFR 890.5650, 21 CFR 890.5720 Device Class: II Use: Prescription

Predicate device

Primary Predicate Device: Cold/Hot Compression 510(k) Number: K223541 Clearance Date: October 27, 2023 Submitter: JKH Health Co., Ltd.

Predicate Device: Polar Care Wave 510(k) Number: K183702 Clearance Date: March 1, 2019 Submitter: Breg Inc.

3. Description of Subject Device

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.

4. Indications for 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.

5. 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	Primary Predicate Device	Predicate Device	Equivalence
510(k) Number	K240986	K223541	K183702	N/A
Submitter	JKH Health Co., Ltd.	JKH Health Co., Ltd.	Breg Inc.	N/A
Device Name/Model	Cold Compression	Cold/Hot Compression	Polar Care Wave	N/A
Product Code
Regulation Number	IRP and ILO	IRP, ILO, and JOW	IRP and ILO	The subject device has
the product codes
covered by the primary
predicate device, and
also identical to the
predicate device.
Indications for 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.	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
postsurgical 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.	The Polar Care Wave System is
intended to treat post-surgical
and acute injuries to reduce
edema, swelling, and pain
where cold and compression
are indicated. It is intended to
be used by or on the order of
licensed healthcare
professionals in hospitals,
outpatient clinics, athletic
training settings, or home
settings.	The subject device has
the Indications for Use
covered by the primary
predicate device, and
also substantially
equivalent to the
predicate device.
Intended Users	Health Care Professionals and	Health Care Professionals and	Health Care Professionals and	Identical
Age range of the target
population	lay users (under prescription)
Adult; children and the elderly
should only use the product
under direct supervision of a
medical professional	lay users (under prescription)
Adult; children and the elderly
should only use the product
under direct supervision of a
medical professional	lay users (under prescription)
Adult; children and the elderly
should only use the product
under direct supervision of a
medical professional	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
Voluntary Standards?	Yes	Yes	Yes	Identical
Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety?	Yes	Yes	Yes	Identical
Therapy	Cold and Compression
Work together or independently	Cold, Heat, Contrast and
Compression	Cold and Compression
Work together or independently	The subject device has
the therapy covered by
the primary predicate
device, and also
identical to the
predicate device. The
difference between the
subject device and the
primary predicate
device is the former
does not provide heat or
contrast therapy.
Cold Therapy	45°F - 55°F	Default: 50°F
Custom: 41°F-55°F
Default, continuous: 50°F
Custom, continuous: 41°F-50°F	45°F - 60°F	Equivalent Note 1
Heat Therapy	Not Available	Default: 105°F
Custom: 105°F-109°F
Default, continuous: 105°F
Custom, continuous: 105°F-109°F	Not Available	Identical to the
predicate device. The
difference between the
subject device and the
primary predicate
device is the former
does not provide heat or
contrast therapy.
Compression Setting	0 - 60 mmHg	Compression Therapy Alternate
mode: 15 -75 mm Hg
Compression Therapy Continuous
mode: 15 -75 mm Hg	Available in two levels
Low (0-25 mmHg)
Regular (0-50 mmHg)	Equivalent Note 2
Reservoir Fluid
Capacity	620 mL	350 mL	Not Available	Different, but it will not
raise any new issue of
the safety or
effectiveness.
Recommended
Coolant	Tap Water	90% Distilled Water,
10% Isopropyl Alcohol	Tap Water	Identical to the
predicate device. The
difference between the
subject device and the
primary predicate
device is the former
does not provide heat or
contrast therapy.
Water Cooling Source	Ice	Vapor compression	Ice	Identical to the
predicate device. The
difference between the
subject device and the
primary predicate
device is the former
does not provide heat or
contrast therapy.
User Interface	Keypad with indicator lights or	Touch Screen	Keypad with indicator lights	Different from the
	LCD screen			primary predicate
Dimensions	L235xW235xH280mm	L295xW285xH295 mm	Not Available	device and similar to
the predicate device. It
will not raise any new
issue of the safety or
effectiveness.
Different. The
difference of
dimensions does not
change the product
performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Weight Approx.	2.4kg	8.2kg	Not Available	Different. The
difference of weight
does not change the
product performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Types of Garments	Various anatomical thermal
garments for: Back,
Elbow/Universal,
Shoulder, Knee, Ankle, Hip.	Various anatomical thermal
garments for: Back, Elbow,
Shoulder, Knee, Ankle, Hip.
DVT Garments: Calf and Foot	Various anatomical thermal
garments for: Back, Universal,
Shoulder, Knee, Foot/Ankle,
Hip.	The subject device has
the garments covered
by the primary
predicate device, and
also substantially
equivalent to the
predicate device.
Biocompatibility of
Patient Contacting
Material	Biocompatible	Biocompatible	Biocompatible	Identical
Sterile/Non-Sterile	Non-sterile	Non-sterile	Non-sterile	Identical
Cleaning Disinfection
Validation of Labeling	Yes	Yes	Yes	Identical
Operational and
Environmental
Conditions	- Normal working ambient
temperature: 5~40°C

Normal working ambient
humidity: 15%~90%
Store and transport ambient
temperature: -25~70°C
Store and transport ambient
humidity: 10~90%
Atmospheric pressure:
70106kPa | - Normal working ambient
temperature: 1627°C
Normal working ambient
humidity: Below 60%
Store and transport ambient
temperature: 1~50°C
Store and transport ambient
humidity: Below 60%
Atmospheric pressure:
70106kPa | - Normal working ambient
temperature: 540°C
Normal working ambient
humidity: 15%~90%
Store and transport ambient
temperature: -25~70°C
Store and transport ambient
humidity: 10~90%
Atmospheric pressure:
70~106kPa | Identical to the
predicate device. The
difference between the
subject device and the
primary predicate
device is the former
does not provide heat or
contrast therapy. |

Table 1. Comparison between the subject device and the predicate device

Equivalent Note 1: The temperature range of cold therapy for the subject device is within that of the primary predicate device and the predicate device. In addition, the temperature of cold therapy for both the subject and predicate devices can be adjusted and determined by the health care professionals or on the order of health care professionals. Therefore, the temperature difference of cold therapy between the subject and predicate devices is insignificant. Such a difference between the subject and predicate devices does not raise any new issues of safety or effectiveness.

Equivalent Note 2: The pressure range of compression therapy for the subject device is within that of the primary predicate device, and is slightly higher than that of the predicate device. In addition, the pressure level can be adjusted and determined for both the subject device and the predicate device by the health care professionals or on the order of health care professionals. Therefore, the difference of compression pressure between the subject and predicate devices is insignificant. Such a difference between the subject device and the predicate device does not raise any new issues of safety or effectiveness.

6. Substantial Equivalence

As discussed above and shown in the above table, the subject device in this submission has the identical or similar performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness. Also, the differences between the subject and predicate devices do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness to the predicate device.

Identical to the predicate device, the subject device has multiple and visual safety alarms built into the system, including low pressure alarm and low battery alarm. The microprocessor and pump units can be powered by the internal rechargeable battery, or can be connected to the main AC power line (through the battery charger / AC adaptor). The skin contact components and materials of the subject device are identical to those of the predicate device in formulation, suppliers, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Therefore, there is no issue or concern of biocompatibility.

7. Non-Clinical Tests Performed

(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

8. Clinical Testing

Clinical testing was not needed in support of this 510(k) application.

9. Conclusion

The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.