Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that provides thermal and compression therapy with a focus on mechanical and electrical safety standards, and software verification according to FDA guidance for general medical device software. There is no mention of AI, ML, image processing, or data sets for training or testing AI/ML models.

Therapeutic

Yes.
The device's intended use is to treat post-surgical and acute injuries to reduce edema, swelling, and pain, and to reduce the risk of deep venous thrombosis (DVT), which aligns with the definition of a therapeutic device.

Diagnostic

No

The device is described as a therapeutic device for conditions like edema, swelling, pain, and DVT prophylaxis, combining cold/hot therapy and air compression. It does not mention any function for identifying or diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions physical components like thermal-therapy wraps, DVT wraps, a main device, and an optional DVT device, indicating it is a hardware device with embedded software.

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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The described device provides physical therapies (cold, heat, compression) applied externally to the body. It treats conditions directly rather than analyzing biological samples.
Intended Use: The intended use clearly states treatment of post-surgical and acute injuries, reduction of edema, swelling, pain, and DVT prevention. These are all therapeutic applications, not diagnostic ones based on in vitro analysis.
Device Description: The description focuses on the physical components (wraps, main device, DVT device) and their functions in applying thermal and compression therapy. There is no mention of analyzing biological 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/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.

Product codes

IRP, ILO, JOW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed health care professionals in rehabilitation facilities, 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

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

(a) ANSI AAMI ES60601-1 "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".

In addition to the compliance of voluntary standards, bench performance tests for the user interface and display performance, operation time, the cooling temperature, heating temperature, pressure test, low pressure alarm, inflation cycle times, and leakage and burst testing were conducted in support of substantial equivalence, and the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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

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

Not Found

Predicate Device(s)

K193550

Reference Device(s)

K061866

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

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +86-755-27926589 Fax: +86-755-29970323 Email: sales@JKHhealth.com 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,
LLC	ThermoTek, Inc.	N/A
Device Name/Model	Cold/Hot Compression	Therm-X	VascuTherm	N/A
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	Therm-X (Therm-X Home and
Therm-X AT) combines cold,
heat, contrast, and compression
therapy. Therm-X 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.
Therm-X Home systems also
provide DVT therapy. Therm-
X Home systems with DVT
therapy are 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.	Treatment of disorders
associated with vascular or
lymphatic insufficiency such as
Chronic Venous Insufficiency
(CVI), venous stasis ulcers,
post-mastectomy edema and
chronic lymphedema.
Reduction of edema associated
with soft tissue injuries such as
bums, postoperative edema,
and ligament sprains.
Localized thermal therapy (hot
or cold) for post traumatic and
post surgical medical and/or
surgical conditions.
Decrease the risk of deep
venous thrombosis (DVT).
Aids the blood flow back to the
heart.	Identical
	the order of, licensed health
care professionals in
rehabilitation facilities,
outpatient clinics, athletic
training settings, and home
settings.	Therm-X (Therm-X Home and
Therm-X AT) 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.	Treat and assist healing of
cutaneous ulceration (wounds),
reduce would healing time,
enhance arterial circulation
(blood flow), reduce
compartmental pressures,
reduce edema (swelling),
reduce the need for
anticoagulant (blood thinning)
medications.
Intended Users	Health Care Professionals and
lay users (under prescription)	Health Care Professionals and
lay users (under prescription)	Health Care Professionals and
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
Voluntary Standards?	Yes	Yes	Yes	Identical
Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety?	Yes	Yes	Yes	Identical
Cold Therapy	Default: 50°F
Custom: 41°F-55°F
Default, continuous: 50°F
Custom, continuous: 41°F - 50°F	Default: 34°F, 45°F, 55°F
Custom: 34°F - 55°F
Default, continuous: 40°F, 45°F,
50°F
Custom, continuous: 40°F - 50°F	Default: 49°F
Custom: 43°F-49°F
Default, continuous: 49°F
Custom, continuous: 43°F - 49°F	Equivalent Note 1
Heat Therapy	Default: 105°F
Custom: 105°F-109°F
Default, continuous: 105°F
Custom, continuous: 105°F -
109°F	Default: 105°F, 107°F, 110°F
Custom: 105°F -110°F
Default, continuous: 105°F, 107°F
Custom, continuous: 105°F -
107°F	Default: 105°F
Custom: 100°F-105°F
Default, continuous: 105°F
Custom, continuous: 100°F -
105°F	Equivalent Note 2
Edema Pressure
Levels	Compression Therapy Alternate
mode: 15 -75 mm Hg
Compression Therapy Continuous
mode: 15 -75 mm Hg	Available in four levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg)
For continuous treatment,
available in three levels:
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg)	Compression Therapy 3 Settings:
Low (15 mm Hg)
Medium (30 mm Hg)
High (50 mm Hg)	Equivalent Note 3
Static or Intermittent
Pressure	Both	Both	Intermittent Pressure available	Identical
DVT Only	Available	Available for Therm-X Home
Model	Available	Identical
DVT Pressure	Calf: 55 mmHg
Foot: 130 mmHg	Calf: 50-70 mmHg
Foot: 90 - 130 mmHg	Calf: 45 mmHg
Foot: 100 mmHg	Equivalent Note 4
Cycle Length (for
Heat, Cold, And
Compression)	Default: 30 minutes
Custom: 1 - 60 minutes	Default: 10 or 20 minutes
Custom: 3 - 40 minutes
Continuous: 10-40 minutes
active, 30-60 minutes rest	Default: 90 minutes	Equivalent Note 5
Contrast Therapy	Heat: 105°F
Cold: 49°F	Heat: 105°F
Cold: 38°F	Heat: 105°F
Cold: 49°F	Equivalent Note 6
Cycle Length (for
Contrast Therapy)	Heat: 10 minutes
Cold: 20 minutes	Heat: 3-10 minutes
Cold: 3-10 minutes
Total treatment: 6-60 minutes	Heat: 10 minutes
Cold: 20 minutes	Equivalent Note 7
DVT Cycle Length	No specified time interval. DVT
can be stopped at any time by the
user.	No specified time interval. DVT
can be stopped at any time by the
user.	No specified time interval. DVT
can be stopped at any time by the
user.	Identical
Edema Compression
and DVT Compression
at the same time	Available
Edema Compression must be
combined with cold, heat, or
contrast therapy	Available
Edema Compression (Lite, Low,
Medium, High) must be	Available
Edema Compression (Lite, Low,
Medium, High) must be	Identical
		combined with cold, heat, or
contrast therapy	combined with cold, heat, or
contrast therapy
Inflation and Deflation	Inflation: Up to 120 seconds
Deflation: Up to 30 seconds	Inflation: Up to 120 seconds
Deflation: Up to 30 seconds	Inflation: Up to 120 seconds
Deflation: Up to 30 seconds	Identical
Store Cycle Usage
Data	Available	Available	Available	Identical
Chilling Mechanism	Thermoelectric	Thermoelectric	Thermoelectric	Identical
Heating Mechanism	Thermoelectric	Thermoelectric	Thermoelectric	Identical
Reservoir Fluid
Capacity	350 mL	650 mL	300mL	Equivalent Note 8
Recommended
Coolant	90% Distilled Water,
10% Isopropyl Alcohol	90% Distilled Water,
10% Isopropyl Alcohol	90% Distilled Water,
10% Isopropyl Alcohol	Identical
User Interface	Touch Screen	Touch Screen	Touch Screen
Dimensions	L295xW285xH295 mm	15" L x 10.5" W x 9" H	L170xW170xH300 mm	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.	8.2kg	15 lbs. when full of coolant	8.7kg	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.
Operating
Temperature	60°F - 80°F (16°C - 27°C)	60°F - 80°F (16°C - 27°C)	60°F - 80°F (16°C - 27°C)	Identical
Storage Temperature	33°F - 122°F (1°C - 50°C)	33°F - 122°F (1°C - 50°C)	33°F - 122°F (1°C - 50°C)	Identical
Operating Humidity	Below 60% Noncondensing	Below 60% Noncondensing	Below 60% Noncondensing	Identical
Storage Humidity	Below 60% Noncondensing	Below 60% Noncondensing	Below 60% Noncondensing	Identical
Operating
Atmospheric
Pressure and Altitude	700 hPa - 1060 hPa
(corresponds to a max.
elevation of 9,842 ft. 6 in (3000
m))	700 hPa - 1060 hPa
(corresponds to a max.
elevation of 9,842 ft. 6 in (3000
m))	700 hPa - 1060 hPa
(corresponds to a max.
elevation of 9,842 ft. 6 in (3000
m))	Identical
Types of Garments	Various anatomical thermal
garments for: Back, Elbow,
Shoulder, Knee, Ankle, Hip.	Various anatomical thermal
garments for: Back, Elbow,
Shoulder, Knee, Ankle, Hip.	Various anatomical thermal
garments for: Back, Elbow,
Shoulder, Knee, Ankle, Hip.	Identical
Patient Contacting
Material	DVT Garments: Calf and Foot
Thermal garment - nylon fabric
on one side and velvet cloth on
the other side

DVT garment - velvet on both
sides | DVT Garments: Calf and Foot
Thermal garment, reusable
(multi-patient) – 30 denier
nylon coated in urethane

Thermal garment, disposable
(single-patient) – 200 denier
nylon coated in urethane

DVT garment – 200 denier
nylon coated in urethane | DVT Garments: Calf and Foot
Thermal garment- 200 denier
nylon oxford

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

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Equivalent Note 1: The cold therapy of the subject device has the default temperature of 50°F, which is within the range of the Predicate device and is almost the same as that of the Reference device. Similarly, the temperature range of cold therapy for the subject device is either within that of the Predicate device or almost the same as that of the Reference device. And the lowest temperature of cold therapy for the subject device (41 °F) is between that of the Predicate device (34 or 40 °F) and that of the Reference device (43 °F). 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, which at least is similar to the case in K181149. Such a difference between the subject and predicate devices does not raise any new issues of safety or effectiveness.

Equivalent Note 2: The heat therapy of the subject device has the default temperature of 105°F, which is within the range of the Predicate device and is the same as that of the Reference device. Similarly, the subject device has the temperature range of heat therapy almost the range of both the Predicate device and the Reference device. And the highest temperature of heat therapy for the subject device (109 °F) is between that of the Predicate device (110 °F) and that of the Reference device (105 ºF). In addition, the temperature of heat 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 heat therapy between the subject and predicate devices is insignificant, which at least is similar to the case in K181149. Such a difference between the subject and predicate devices does not raise any new issues of safety or effectiveness.

Equivalent Note 3: The lowest edema pressure level of the subject device (15 mmHz) is within that of the Predicate device (5 or 20 mmHg), and is also the same as that of the Reference device (15 mmHg). The highest edema pressure level of the subject device (75 mmHg) is slightly higher than that of both the Predicate device (70 mmHg) and the Reference device (50 mmHg). In addition, the edema 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 edema pressure between the subject and predicate devices is insignificant, which at least is similar to the case in K181149. Such a difference between the subject device and the predicate device does not raise any new issues of safety or effectiveness.

Equivalent Note 4: The DVT pressure of the subject device on the calf is 55mmHg, which is within the range of the Predicate device (50-70 mmHg) and is slightly higher than that of the Reference device (45 mmHg). Similarly, the DVT pressure of the subject device on the foot (130 mmHg) is within the range of the Predicate device (90-130 mmHg) and is somewhat higher than that of the Reference device (100 mmHg). Therefore, the difference of DVT pressure between the subject and predicate devices is insignificant, which at least is similar to the case in K181149. Such a difference between the subject device and the predicate device does not raise any new issues of safety or effectiveness.

Equivalent Note 5: The longest cycle length of the subject device (60 minutes) is the same as or longer than that of the Predicate device (40 or 60 minutes), but it is shorter than that of the Reference device (90 minutes). In addition, the cycle length can be adjusted and determined by the health care professionals or on the order of health care professionals. Therefore, the difference of cycle length between the subject and predicate devices is insignificant, which at least is similar to the case in K181149. Such a difference between the subject device and the predicate device does not affect the safety or effectiveness.

Equivalent Note 6: The contrast therapy of the subject device is slightly different from that of the Predicate device, and is exactly the same as that of the Reference device. Therefore, such a difference

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between the subject device and the predicate device does not raise any new issues of safety or effectiveness.

Equivalent Note 7: The cycle length of the contrast therapy for the subject device is slightly different from the Predicate device, while it is exactly the same between the subject device and the Reference device. Therefore, such a difference between the subject device and the predicate device does not affect the safety or effectiveness.

Equivalent Note 8: The reservoir fluid capacity of the subject device is smaller than that of the Predicate device, while it is larger than that of that of the Reference device. Therefore, the different reservoir fluid capacity between the subject device and the predicate device does not raise any new issues of safety or effectiveness.

7. Substantial Equivalence

As discussed above and shown in the above Table 1, the subject device in this submission has the identical or equivalent 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.

As demonstrated, 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.

8. Non-Clinical Tests Performed

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

(a) ANSI AAMI ES60601-1 "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".

In addition to the compliance of voluntary standards, bench performance tests for the user interface and display performance, operation time, the cooling temperature, heating temperature, pressure test, low pressure alarm, inflation cycle times, and leakage and burst testing were conducted in support of substantial equivalence, and the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Due to the requirement that clothing be worn beneath the wraps by the user, the biocompatibility of the device materials have not been verified by FDA.

9. Clinical Testing

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

10. Conclusion

The test 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.