The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

Treatment of lymphedema
Treatment of chronic venous insufficiency
Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
Reducing venous leg ulcer healing time
Reducing edema due to venous stasis
Enhancing venous return
The device is intended for home, and hospital use.

Device Description

As a portable and rechargeable prescriptive device, the Lymphedema Compression is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional. It applies pressure to treat lymphedema and other edematous conditions.
Supplied clean and non-sterile, the Lymphedema Compression utilizes the pneumatically controlled cuff and is actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit, which is attached to an inflatable cuff/sleeve. The Lymphedema Compression contains an ON/OFF button, a SET button, and a display for user interface. In addition, there is also a port on the control unit for connecting the battery charger/AC adapter plug. The cuff component consists of multiple air chambers/bladders encased inside a soft nylon fabric or equivalent biocompatible fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply press the ON/OFF button to turn on the control unit, to which a cuff containing air chambers/bladders is connected. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg) that cannot be adjusted to a pressure within the specified range via the SET button. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned off, and the cuff deflates to the ambient pressure through a valve inside the control unit. After the rest period, the cycle of inflation and deflation repeats until the device is turned off automatically or manually.

AI/ML Overview

The provided FDA 510(k) summary (K240011) describes the "Lymphedema Compression" device and its substantial equivalence to a predicate device, ManaFlow (K200353).

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly list "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the substantial equivalence relies on demonstrating that the subject device's characteristics and performance are identical to or similar to the predicate device. The primary "acceptance criterion" is functional and technical equivalence to the predicate.

Here's a table based on the comparison provided in the 510(k) summary:

Feature/Criterion	Acceptance Criteria (Based on Predicate Device: ManaFlow K200353)	Reported Subject Device Performance (Lymphedema Compression)	Equivalence
Intended Use	To provide graduated compression in both sustained and intermittent settings for: Treatment of lymphedema, chronic venous insufficiency, stasis dermatitis/venous stasis ulcers (healing & reducing healing time), reducing edema due to venous stasis, enhancing venous return. For home and hospital use.	Identical to Predicate: To provide graduated compression in both sustained and intermittent settings for: Treatment of lymphedema, chronic venous insufficiency, stasis dermatitis/venous stasis ulcers (healing & reducing healing time), reducing edema due to venous stasis, enhancing venous return. For home and hospital use.	Identical
Pressure Setting	Pre-set to 50 mmHg (cannot be adjusted) or adjustable (20-80 mmHg) by physician.	Pre-set to 50 mmHg (cannot be adjusted) or adjustable (20-80 mmHg) by physician.	Identical
Prescription/OTC	Prescription	Prescription	Identical
Power Source	5V DC supply (100-240 VAC input) and 3.7V rechargeable battery	5V DC supply (100-240 VAC input) and 3.7V rechargeable battery	Identical
Battery Charge Time	Approx. 4 hours from depleted state	Approx. 4 hours from depleted state	Identical
Power Supply (Input/Output)	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 Rechargable Batteries	Yes	Yes	Identical
Compliance with Voluntary Standards	Yes (Electrical Safety, Mechanical Safety, Chemical Safety, Thermal Safety, Radiation Safety)	Yes (ANSI AAMI ES60601-1, IEC 60601-1-2)	Identical
Functions and Design	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities.	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities.	Identical
Contraindications	MUST NOT be used for: Suspected DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection; on legs interfering with: vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity; on any neuropathy; on insentitive extremities; where increased venous/lymphatic return is undesirable.	Identical to Predicate.	Identical
Target Population / Users	Patients needing venous return and lymphedema treatment	Patients needing 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 cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities.	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation-deflation) to compress extremities.	Identical
Anatomical Site	Leg (for predicate)	Extremities	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	Inflation in sequence (foot-up), then deflation; repeats.	Inflation in sequence (foot-up), then deflation; repeats.	Identical
System diagnostics	Audible and visual alarms for system faults	Audible and visual alarms for system faults	Identical
Air delivery	Via flexible plastic tube(s) connected directly to air bladder.	Via flexible plastic tube(s) connected directly to air bladder.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Identical
Material Used	Air bladder chambers in soft, non-latex medical fabric or equivalent for comfort/biocompatibility.	Air bladder chambers in soft, non-latex medical fabric or equivalent for comfort/biocompatibility.	Identical
Fastening	Snap and screw	Snap and screw	Identical
Biocompatibility	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Identical
Operating 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	Specific instructions for pump unit and cuffs; air dry.	Specific instructions for pump unit and cuffs; air dry.	Identical
Disposal	Electromechanical device with PCBs and rechargeable batteries; not for landfill; consult local requirements/recycle center.	Electromechanical device with PCBs and rechargeable batteries; not for landfill; consult local requirements/recycle center.	Identical

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there was no clinical test set of patient data, no sample size of patients, and no data provenance relevant to clinical performance evaluation. The "test set" for the device's technical specifications consists of the individual components and the assembled device that underwent non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Since no clinical testing was performed, there was no ground truth established by experts on patient cases. The evaluation of electrical safety, EMC, and physical/performance requirements relies on adherence to published voluntary standards and internal company specifications, not expert consensus on clinical outcomes.

4. Adjudication method for the test set

Not applicable. As no clinical testing or human reader study was conducted, there was no need for an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device (pneumatic compression) and does not involve an algorithm with standalone performance in the context of diagnostic interpretation. Its "performance" is based on mechanical and electrical parameters (e.g., pressure output, cycle time, safety features).

7. The type of ground truth used

The "ground truth" for this submission is adherence to recognized voluntary standards for medical device safety and performance (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the technical specifications and functional characteristics of the legally marketed predicate device. Bench tests validated that the subject device met its own design specifications, which were shown to be identical or very similar to the predicate.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

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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).

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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

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Indications for Use

Submission Number (if known)

K240011

Device Name

Lymphedema Compression

Indications for Use (Describe)

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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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

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

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Prescription Use:

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 iscomprised of a gradient compression sleeveand a portable intermittent pump to providegraduated compression in both sustainedand intermittent settings for use in both thehospital and outpatient setting. It is pre-setto the default setting of 50 mmHg thatcannot be adjusted or can be adjusted by thephysician to a pressure within the specifiedrange. It is intended for use in:Treatment of lymphedemaTreatment of chronic venousinsufficiencyTreatment and promotion ofhealing of stasis dermatitis and venousstasis ulcersReducing venous leg ulcerhealing timeReducing edema due to venousstasisEnhancing venous returnThe device is intended for home, andhospital use.	The ManaFlow system, part numbersMFLOW51 and MFLOW52, is comprised ofa gradient compression sleeve and a portableintermittent pump to provide graduatedcompression in both sustained andintermittent settings for use in both thehospital and outpatient setting. ManaFlow 51is pre-set to the default setting of 50 mmHgand cannot be adjusted, whereas theManaFlow 52 can be adjusted by thephysician to a pressure within the specifiedrange. It is intended for use in:Treatment of lymphedemaTreatment of chronic venousinsufficiencyTreatment and promotion ofhealing of stasis dermatitis and venous stasisulcersReducing venous leg ulcer healingtimeReducing edema due to venousstasisEnhancing venous return	Identical
		The device is intended for home, and hospitaluse.
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 depletedstate).	Takes approximately 4 hours (from depletedstate).	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 rechargeablebatteries	Yes	Yes	Identical
Compliance withVoluntary Standards?	Yes	Yes	Identical
Electrical SafetyMechanical SafetyChemical SafetyThermal SafetyRadiation Safety?	Yes	Yes	Identical
Functions and design	Aids venous return by using cyclic,intermittent, pneumatic pressure application(inflation followed by deflation) tocompress the extremities.	Aids venous return by using cyclic,intermittent, pneumatic pressure application(inflation followed by deflation) to compressthe extremities.	Identical
Contraindication(s)	MUST NOT be used to treat the followingconditions: Persons with suspected, activeor untreated: deep vein thrombosis,ischemic vascular disease, severearteriosclerosis, pulmonary edema,severe congestive heart failure,thrombophlebitis, or an active infection.On the legs where cuffs would interferewith the following conditions: vein ligation,gangrene, dermatitis, open wounds, a recentskin graft, massive edema or extremedeformity of the leg.On any neuropathy.On extremities that are insensitive to pain.Where increased venous or lymphatic returnis undesirable.	MUST NOT be used to treat the followingconditions: Persons with suspected, active oruntreated: deep vein thrombosis, ischemicvascular disease, severe arteriosclerosis,pulmonary edema,severe congestive heart failure,thrombophlebitis, or an active infection.On the legs where cuffs would interfere withthe following conditions: vein ligation,gangrene, dermatitis, open wounds, a recentskin graft, massive edema or extremedeformity of the leg.On any neuropathy.On extremities that are insensitive to pain.Where increased venous or lymphatic returnis undesirable.	Identical
Target Population /Intended Users	Patients who need venous return andlymphedema treatment	Patients who need venous return andlymphedema treatment	Identical
Where Used	Home, Hospital, Surgery Center, Altitudetravel, areas of limited mobility	Home, Hospital, Surgery Center, Altitudetravel, 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) tocompress the extremities	Aids venous return by using cyclic,intermittent, pneumatic pressure application(inflation followed by deflation) to compressthe extremities	Identical
Anatomical Site /Location of treatmentapplication	Extremities	Leg	Identical orSimilar
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 chamberwill inflate in sequence, starting at the foot	In the preset 50mmHg mode, each chamberwill inflate in sequence, starting at the foot	Identical
	the chambers reach the intended pressurelevels. All four chambers will then deflate	the chambers reach the intended pressurelevels. 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 insequence, starting at the foot and working	first, and each chamber will inflate insequence, 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 biocompatibilitycompliance.	patient comfort and biocompatibilitycompliance.
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 andDisinfecting	• Clean the outer surface of the pumpunit using a soft cloth, moistened withsoapy 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 usinga soft cloth, moistened with soapy water or70% isopropyl alcohol and let air dry.• To ensure the unit IS completely dry priorto use, leave unit in the OFFcondition and disconnected from thewall outlet for 30 minutes after cleaning ordisinfecting.	• Clean the outer surface of the pumpunit using a soft cloth, moistened with soapywater 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 asoft cloth, moistened with soapy water or70% isopropyl alcohol and let air dry.• To ensure the unit IS completely dry priorto use, leave unit in the OFFcondition and disconnected from thewall outlet for 30 minutes after cleaning ordisinfecting.	Identical
Disposal	This unit is an electromechanical devicethat includes printed circuit boards andrechargeable batteries.Do not discard in landfill. Consult localcounty requirements for proper disposalinstructions. Pump control units containrechargeable batteries. Do not discard thepump unit in regular waste. Bring the unitto your local recycle center or contact theseller	This unit is an electromechanical device thatincludes printed circuit boards andrechargeable batteries.Do not discard in landfill. Consult localcounty requirements for proper disposalinstructions. Pump control units containrechargeable batteries. Do not discard thepump unit in regular waste. Bring the unit toyour local recycle center or contactManaMed, Inc.	Identical

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

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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.

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).