Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a simple pneumatic compression device with pre-set or manually adjustable pressure settings and a basic ON/OFF and SET button interface. There is no mention of adaptive algorithms, learning capabilities, or complex data processing that would indicate AI/ML. The software verification mentioned is standard for medical devices and does not imply AI/ML functionality.

Therapeutic

Yes
The device is described as "Treatment of lymphedema," "Treatment of chronic venous insufficiency," "Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers," and "Reducing edema due to venous stasis," which are all therapeutic claims.

Diagnostic

No

The device description and intended use clearly state that the Lymphedema Compression is a treatment device, designed to apply pressure for therapeutic purposes, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including a pump, battery, control unit, plastic case, ON/OFF button, SET button, display, port, and inflatable cuff/sleeve with air chambers/bladders. It is not solely 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Lymphedema Compression device is a physical therapy device that applies external pressure to the extremities. It does not analyze biological samples.
Intended Use: The intended uses listed are all related to the physical treatment of conditions like lymphedema and venous insufficiency through compression, not through the analysis of biological samples.
Device Description: The description details a pump, sleeve, and controls for applying pneumatic pressure. There is no mention of components for sample collection, analysis, or reagents.

Therefore, the Lymphedema Compression 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

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.

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

JOW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility

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 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 tests have been performed on the physical requirements, electrical requirement, and performance requirement; 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.

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.

K200353

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

February 23, 2024

JKH Health Co., Ltd. % Bill Dai Managing Member Jkh Usa LLC 20 Fairbanks. Suite 171 Irvine, California 92618

Re: K240011

Trade/Device Name: Lymphedema Compression Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: December 8, 2023 Received: January 2, 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).

1

approvals in the device master record (21 CFR 820.181).

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

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 medical devices and radiation-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,

Image /page/1/Picture/6 description: The image shows the name "Eric E. Richardson -S" in a clear, sans-serif font. The text is positioned on the left side of the image. To the right of the name, there is a faint, stylized logo that appears to be a company or organization emblem.

for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Submission Number (if known)

K240011

Device Name

Lymphedema Compression

Indications for Use (Describe)

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.

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)

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3

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: 12/8/2023

2. Subject Device

Trade/Device Name: Lymphedema Compression Common Name: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

3. Predicate device

Predicate Device: ManaFlow 510(k) Number: K200353 Clearance Date: August 6, 2020 Submitter: ManaMed, Inc.

4. Description of Subject Device

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.

5. Indications for Use

4

Prescription 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.

6. Summary of Substantial Equivalence

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

	Subject Device	Primary Predicate Device	Equivalence
510(k) Number	N/A	K200353	N/A
Device Name/Model	Lymphedema Compression	ManaFlow	N/A
Submitter	JKH Health Co., Ltd.	ManaMed, Inc.	N/A
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.	The ManaFlow system, part numbers
MFLOW51 and MFLOW52, 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. ManaFlow 51
is pre-set to the default setting of 50 mmHg
and cannot be adjusted, whereas the
ManaFlow 52 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	Identical
		The device is intended for home, and hospital
use.
Prescription or OTC	Prescription	Prescription	Identical
Power Source(s)	5V DC power supply (100-240 VAC input)
and 3.7V rechargeable battery	5V DC power supply (100-240 VAC input)
and 3.7V rechargeable battery	Identical
Battery Charge	Takes approximately 4 hours (from depleted
state).	Takes approximately 4 hours (from depleted
state).	Identical
Power Supply	Input: 100 - 240 Vac, 50 - 60 Hz,
Output: 5 Vdc @ 2 Amp)	Input: 100 - 240 Vac, 50 - 60 Hz,
Output: 5 Vdc @ 2 Amp)	Identical
Internal rechargeable
batteries	Yes	Yes	Identical
Compliance with
Voluntary Standards?	Yes	Yes	Identical
Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety?	Yes	Yes	Identical
Functions and design	Aids venous return by using cyclic,
intermittent, pneumatic pressure application
(inflation followed by deflation) to
compress the extremities.	Aids venous return by using cyclic,
intermittent, pneumatic pressure application
(inflation followed by deflation) to compress
the extremities.	Identical
Contraindication(s)	MUST NOT be used to treat the following
conditions: Persons with suspected, active
or untreated: deep vein thrombosis,
ischemic vascular disease, severe
arteriosclerosis, pulmonary edema,
severe congestive heart failure,
thrombophlebitis, or an active infection.
On the legs where cuffs would interfere
with the following conditions: vein ligation,
gangrene, dermatitis, open wounds, a recent
skin graft, massive edema or extreme
deformity of the leg.
On any neuropathy.
On extremities that are insensitive to pain.
Where increased venous or lymphatic return
is undesirable.	MUST NOT be used to treat the following
conditions: Persons with suspected, active or
untreated: deep vein thrombosis, ischemic
vascular disease, severe arteriosclerosis,
pulmonary edema,
severe congestive heart failure,
thrombophlebitis, or an active infection.
On the legs where cuffs would interfere with
the following conditions: vein ligation,
gangrene, dermatitis, open wounds, a recent
skin graft, massive edema or extreme
deformity of the leg.
On any neuropathy.
On extremities that are insensitive to pain.
Where increased venous or lymphatic return
is undesirable.	Identical
Target Population /
Intended Users	Patients who need venous return and
lymphedema treatment	Patients who need venous return and
lymphedema treatment	Identical
Where Used	Home, Hospital, Surgery Center, Altitude
travel, areas of limited mobility	Home, Hospital, Surgery Center, Altitude
travel, areas of limited mobility	Identical
Application	Non-invasive / external	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Identical
Basis of operation	Aids venous return by using cyclic,
intermittent, pneumatic pressure application
(inflation followed by deflation) to
compress the extremities	Aids venous return by using cyclic,
intermittent, pneumatic pressure application
(inflation followed by deflation) to compress
the extremities	Identical
Anatomical Site /
Location of treatment
application	Extremities	Leg	Identical or
Similar
System management	Microprocessor	Microprocessor	Identical
Pressure Source	Micro pump controlled by microprocessor	Micro pump controlled by microprocessor	Identical
Operating Modes	Preset and adjustable modes	Preset and adjustable modes	Identical
Working Pressure	Preset at 50 mmHg and adjustable from 20

80 mmHg | Preset at 50 mmHg and adjustable from 20 -
80 mmHg | Identical |
| Cycle Time | In the preset 50mmHg mode, each chamber
will inflate in sequence, starting at the foot | In the preset 50mmHg mode, each chamber
will inflate in sequence, starting at the foot | Identical |
| | the chambers reach the intended pressure
levels. All four chambers will then deflate | the chambers reach the intended pressure
levels. All four chambers will then deflate to | |
| | to the low pressure level. This cycle of | the low pressure level. This cycle of inflation | |
| | inflation and deflation will continue until | and deflation will continue until the device is | |
| | the device is turn off. | turn off. | |
| | In the adjustable 20 - 80 mmHg mode, the | In the adjustable 20 - 80 mmHg mode, the | |
| | pressure of each chamber could be adjusted | pressure of each chamber could be adjusted | |
| | first, and each chamber will inflate in
sequence, starting at the foot and working | first, and each chamber will inflate in
sequence, starting at the foot and working up | |
| | up toward the knee until all of the chambers | toward the knee until all of the chambers | |
| | reach the intended pressure levels. All the | reach the intended pressure levels. All the | |
| | chambers will then deflate to the low | chambers will then deflate to the low | |
| | pressure level. This cycle of inflation and | pressure level. This cycle of inflation and | |
| | deflation will continue until the device is | deflation will continue until the device is turn | |
| System diagnostics | turn off.
Audible and visual alarms prompt | off.
Audible and visual alarms prompt | Identical |
| | recognition of system faults | recognition of system faults | |
| Air delivery from | Via flexible plastic tube(s) connected | Via flexible plastic tube(s) connected directly | Identical |
| pump to cuff bladder | directly to the air bladder | to the air bladder | |
| Sterility | Clean / non-sterile | Clean / non-sterile | Identical |
| Leg cuff usage | Single Patient Use | Single Patient Use | Identical |
| Material Used | Air bladder chambers encased in a covering | Air bladder chambers encased in a covering | Identical |
| | of soft and nonlatex medical fabric or | of soft and nonlatex medical fabric or | |
| | equivalent medical material for increased | equivalent medical material for increased | |
| | patient comfort and biocompatibility
compliance. | patient comfort and biocompatibility
compliance. | |
| Fastening between | Snap and screw | Snap and screw | Identical |
| the plastic case and | | | |
| the fabric wrap | | | |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Software | Moderate | Moderate | Identical |
| Temperature | +10 ℃ (50 ºF) to +40 ºC (104 ºF) | +10 ℃ (50 ºF) to +40 ºC (104 ºF) | Identical |
| Humidity | 30%-75% | 30%-75% | Identical |
| Cleaning and
Disinfecting | • Clean the outer surface of the pump
unit using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol.
• Do not use abrasive or volatile cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from the cuff.
• Hand wash the exterior of the cuffs using
a soft cloth, moistened with soapy water or
70% isopropyl alcohol and let air dry.
• To ensure the unit IS completely dry prior
to use, leave unit in the OFF
condition and disconnected from the
wall outlet for 30 minutes after cleaning or
disinfecting. | • Clean the outer surface of the pump
unit using a soft cloth, moistened with soapy
water or 70% isopropyl alcohol.
• Do not use abrasive or volatile cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from the cuff.
• Hand wash the exterior of the cuffs using a
soft cloth, moistened with soapy water or
70% isopropyl alcohol and let air dry.
• To ensure the unit IS completely dry prior
to use, leave unit in the OFF
condition and disconnected from the
wall outlet for 30 minutes after cleaning or
disinfecting. | Identical |
| Disposal | This unit is an electromechanical device
that includes printed circuit boards and
rechargeable batteries.
Do not discard in landfill. Consult local
county requirements for proper disposal
instructions. Pump control units contain
rechargeable batteries. Do not discard the
pump unit in regular waste. Bring the unit
to your local recycle center or contact the
seller | This unit is an electromechanical device that
includes printed circuit boards and
rechargeable batteries.
Do not discard in landfill. Consult local
county requirements for proper disposal
instructions. Pump control units contain
rechargeable batteries. Do not discard the
pump unit in regular waste. Bring the unit to
your local recycle center or contact
ManaMed, Inc. | Identical |

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

5

6

7

7. Substantial Equivalence

As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device. And there is no difference between the subject device and the predicate device, and there is no new issue of safety or effectiveness. The subject device is designed for the same intended use as the predicated device. The comparison of the specifications demonstrates the functional equivalence of the products, concluding that the subject device is substantially equivalent to the predicate device.

The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver pressurized air to bladders that are attached to the patient's extremities. Each cycle consists of inflation of air bladders, followed by the bladder deflation without any compression.

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 are powered by internal rechargeable batteries, and can be connected to the main AC power line (through the battery charger / AC adaptor) while in use, allowing uninterrupted prolonged service. In addition, the cuff is comprised of multiple air bladder chambers encased in a covering of soft and non-latex nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance. 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.). There is no issue or concern of biocompatibility.

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 tests have been performed on the physical requirements, electrical requirement, and performance requirement; 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.

9. Clinical Testing

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

10. 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.