The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to:

· Aid in the prevention of DVT;
· Enhance blood circulation:
· Diminish post-operative pain and swelling;
· Reduce wound healing time;
Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Device Description

The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).
The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit.

AI/ML Overview

The provided text does not contain detailed information about a study proving the device meets acceptance criteria. Instead, it describes a 510(k) premarket notification for the "PlasmaWave" device, asserting its substantial equivalence to predicate devices (PlasmaFlow and Cirona 6200 Deep Vein Thrombosis Prevention System).

Therefore, I cannot provide all the requested information. However, I can extract what is available regarding acceptance criteria and the methods used to demonstrate substantial equivalence.

Here's a summary based on the provided text:

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

The document presents a comparison table (Table 1) between the subject device (PlasmaWave) and two predicate devices (PlasmaFlow, K160318; Cirona 6200, K141578) to demonstrate substantial equivalence. It implies that the "acceptance criteria" are met if the subject device is either identical or sufficiently similar to the predicate devices without raising new issues of safety or effectiveness.

Feature / Criteria	Subject Device (PlasmaWave)	Primary Predicate Device (PlasmaFlow, K160318)	Predicate Device (Cirona 6200, K141578)	Equivalence / Performance Statement
Intended Use	Aid in prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in lower limbs. Aid in DVT prophylaxis for stationary persons.	(Identical statement as Subject Device)	Preventatively to increase venous blood flow in patients at risk of DVT.	Identical (to PlasmaFlow); Similar (to Cirona 6200)
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Identical
Battery Specifications	3.7V rechargeable battery	3.7V rechargeable battery	10.8V rechargeable battery	Identical or similar. Voltage difference will not raise any new safety/effectiveness issue.
Battery Charge Time	~4 hours (from depleted)	~4 hours (from depleted)	~5 hours (from depleted)	Identical or similar. Charging time difference does not change product performance/parameters, will not raise new safety/effectiveness issue.
Power Supply	Input: 100-240 Vac, 50-60 Hz; Output: 12 Vdc @ 2 A	Input: 100-240 Vac, 50-60 Hz; Output: 5 Vdc @ 1 A	Input: 100-240 Vac, 50-60 Hz; Output: 14 Vdc @ 2 A	Similar. Voltage difference does not change product performance/parameters, will not raise new safety/effectiveness issue.
Internal Recharg. Batt.	Yes	Yes	Yes	Identical
Compliance Std.	Yes	Yes	Yes	Identical
Safety (Elec, Mech, Chem, Therm, Rad)	Yes	Yes	Yes	Identical
Functions and design	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress lower extremities.	(Identical statement as Subject Device)	(Identical statement as Subject Device)	Identical
Contraindication(s)	Persons with suspected, active or untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection. On legs where cuffs interfere with: vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity. On any neuropathy. On insensitive extremities. Where increased venous or lymphatic return is undesirable.	(Identical statement as Subject Device)	Severe atherosclerosis or other ischemic vascular diseases, suspected/known acute DVT, severe CHF, existing pulmonary edema/embolisms, extreme limb deformity. Local skin/tissue condition where garments interfere: gangrene, untreated/infected wounds, recent skin graft, dermatitis, known malignancy in legs, limb infections (cellulitis) without antibiotic coverage, lymphangiosarcoma.	Identical (to PlasmaFlow); Similar (to Cirona 6200)
Target Population	Patients who need venous return.	Patients who need venous return.	Patients who need venous return.	Identical
Where Used	Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility.	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	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant	Identical
Basis of operation	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress lower extremities.	(Identical statement as Subject Device)	(Identical statement as Subject Device)	Identical
Anatomical Site	Lower extremities	Lower extremities	Lower extremities	Identical
System management	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Identical
Pressure Source	Micro pump controlled by electronic processor	Micro pump controlled by electronic processor	Micro pump controlled by electronic processor	Identical
Operating Mode	Continuous Operation	Continuous Operation	Continuous Operation	Identical
Working Pressure	Preset at 55 mmHg	Preset at 55 mmHg	Preset at 40 mmHg	Identical (to PlasmaFlow); Similar (to Cirona 6200). Will not raise new safety/effectiveness issue.
Cycle Time	Approximately 60 seconds	Approximately 60 seconds	Approximately 60 seconds	Identical
System diagnostics	Audible and visual alarms prompt recognition of system faults	Audible and visual alarms prompt recognition of system faults	Audible and visual alarms prompt recognition of system faults	Identical
Air delivery from pump to cuff bladder	Via flexible plastic tube(s) connected to the air bladder.	Via flexible plastic tube(s) connected to the air bladder.	Via flexible plastic tube(s) connected to the air bladder.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Single Patient Use	Identical
Material Used	Single air bladder encased in soft, nonlatex, non-woven medical fabric or equivalent, for comfort and biocompatibility.	(Identical statement as Subject Device)	(Identical statement as Subject Device)	Identical
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical. No issue or concern of biocompatibility due to identical materials/formulation.
Software	Moderate	Moderate	Moderate	Identical
Dimensions	220x70x48.5 mm	116x65x19 mm	110x180x270 mm	Different. Difference in dimensions does not change product performance/parameters, will not raise new safety/effectiveness issue.
Weight	Approx. 0.38kg	0.23kg	2.3kg	Different. Difference in weight does not change product performance/parameters, will not raise new safety/effectiveness issue.
Temperature	+10 °C (50 °F) to +40 °C (104 °F)	+10 °C (50 °F) to +40 °C (104 °F)	+5 °C (41 °F) to +40 °C (104 °F)	Identical or similar
Humidity	30%-75%	30%-75%	15%-93%	Identical or similar

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

The document does not describe a clinical "test set" in the sense of patient data used for evaluating the device's clinical performance. The evaluation is based on a comparison to predicate devices and non-clinical bench tests.

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

Not applicable. There is no mention of experts establishing ground truth for a clinical test set.

4. Adjudication method for the test set

Not applicable. There is no clinical test set mentioned.

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

Not applicable. The device is a pneumatic compression pump, not an AI-assisted diagnostic or imaging device. There is no mention of human readers or AI assistance.

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

Not applicable. This is not an algorithm-only device. The submission relies on demonstrating substantial equivalence to a mechanically similar predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of the 510(k) submission, the "ground truth" for "acceptability" is implicitly established by the legally marketed predicate devices. The subject device is deemed acceptable if it can demonstrate substantial equivalence to these predicates without raising new questions of safety or effectiveness. This is supported by:

Comparison of technical characteristics: Detailed feature-by-feature comparison.
Compliance with voluntary standards: Adherence to established safety and electromagnetic compatibility standards (ANSI AAMI ES60601-1, IEC 60601-1-2).
Bench tests: Verification of physical, electrical, and performance requirements.
Software verification: According to FDA guidelines.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable. No training set is mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

May 26, 2021

ManaMed, Inc. % Bill Quanqin Dai, Ph.D. JKH USA, LLC 14271 Jeffrev Rd. #246 Irvine, California 92620

Re: K211253

Trade/Device Name: PlasmaWave Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 14, 2021 Received: April 26, 2021

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Nicole Gillette Acting 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

Enclosure

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Indications for Use

510(k) Number (if known) K211253

Device Name PlasmaWave

Indications for Use (Describe)

· Aid in the prevention of DVT;
· Enhance blood circulation:
· Diminish post-operative pain and swelling;
· Reduce wound healing time;

· Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

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

1. Submitter's Information

Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Date of Preparation: 04/16/2021

2. Subject Device

Trade/Device Name: PlasmaWave Regulation Description: 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

Primary Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed, Inc.

Predicate Device: Cirona 6200 Deep Vein Thrombosis Prevention System 510(k) Number: K141578 Clearance Date: June 27, 2014 Submitter: Devon Medical, Inc.

4. Description of Subject Device

The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit.

5. Indications for Use

Prescription Use:

The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

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Aid in the prevention of DVT; •
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

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	Predicate Device	Equivalence
510(k) Number	N/A	K160318	K141578	N/A
Submitter	ManaMed, Inc.	ManaMed, Inc.	Devon Medical, Inc.	N/A
Device Name/Model	PlasmaWave	PlasmaFlow	Cirona 6200 Deep VeinThrombosis Prevention System	N/A
Intended Use	The PlasmaWave is intended tobe an easy to use portablesystem, prescribed by aphysician, for use in the homeor clinical setting to helpprevent the onset of DVT inpatients by stimulating bloodflow in the extremities(stimulating musclecontractions). This device canbe used to:Aid in the preventionof DVT;Enhance bloodcirculation;Diminish post-operative pain and swelling;Reduce woundhealing time;Aid in the treatmentand healing of stasis dermatitis,venous stasis ulcers, arterialand diabetic leg ulcers, chronicvenous insufficiency andreduction of edema in the lowerlimbs.The unit can also be used as anaid in the prophylaxis for DVTby persons expecting to bestationary for long periods oftime.	The PlasmaFlow, modelPF0001, is intended to be aneasy to use portable system,prescribed by a physician, foruse in the home or clinicalsetting to help prevent the onsetof DVT in patients bystimulating blood flow in theextremities (simulating musclecontractions). This device canbe used to:Aid in the preventionof DVT:Enhance bloodcirculation;Diminish post-operative pain and swelling:Reduce woundhealing time;Aid in the treatmentand healing of: stasisdermatitis, venous stasis ulcers,arterial and diabetic leg ulcers,chronic venous insufficiencyand reduction of edema in thelower limbs.The unit can also be used as anaid in the prophylaxis for DVTby persons expecting to bestationary for long periods oftime.	The Cirona 6200 Series systemis a prescription deviceintended to be usedpreventatively to increasevenous blood flow in patientsat risk of deep veinthrombosis due to theassociated risk factors forthrombus formation during:trauma, critical care, generalmedicine, general surgery, aswell as neurological,orthopedic, urologic, obstetricconditions and treatments.	Identical
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Identical
Battery Specifications	3.7V rechargeable battery	3.7V rechargeable battery	10.8V rechargeable battery	Identical or similar. Thevoltage difference ofbatteries will not raiseany new issue of thesafety or effectiveness.
Battery Charge	Takes approximately 4 hours(from depleted state).	Takes approximately 4 hours(from depleted state).	Takes approximately 5 hours(from depleted state).	Identical or similar. Thedifference of chargingtime does not changethe productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60Hz,Output: 12 Vdc @ 2 A	Input: 100 - 240 Vac, 50 - 60Hz,Output: 5 Vdc @ 1 A	Input: 100 - 240 Vac, 50 - 60Hz,Output: 14 Vdc @ 2 A	Similar. The voltagedifference of powersupply used does notchange the productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Internal rechargeablebatteries	Yes	Yes	Yes	Identical
Compliance withVoluntary Standards?	Yes	Yes	Yes	Identical
Electrical SafetyMechanical SafetyChemical SafetyThermal SafetyRadiation Safety?	Yes	Yes	Yes	Identical
Functions and design	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities.	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities.	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities	Identical
Contraindication(s)	The PlasmaFlow MUST NOTbe used to treat the followingconditions: Persons withsuspected, active or untreated:deep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heartfailure, thrombophlebitis, or anactive infection.On the legs where cuffs wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg.On any neuropathy.On extremities that areinsensitive to pain.Where increased venous orlymphatic return is undesirable.	The PlasmaFlow MUST NOTbe used to treat the followingconditions: Persons withsuspected, active or untreated:deep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heartfailure, thrombophlebitis, or anactive infection.On the legs where cuffs wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg.On any neuropathy.On extremities that areinsensitive to pain.Where increased venous orlymphatic return is undesirable.	The Cirona 6200 Series systemshould NOT be used in thefollowing conditions:· Severe atherosclerosis orother ischemic vasculardiseases• Suspected or known acutedeep vein thrombosis• Severe congestive cardiacfailure• Existing pulmonary edema• Existing pulmonaryembolisms• Extreme deformity of thelimbs• Any local skin or tissuecondition in which thegarments would interfere:· Gangrene• Untreated or infected wounds· Recent skin graft· Dermatitis• Known presence ofmalignancy in the legs	Identical
			• Limb infections, includingcellulitis, that have not receivedantibiotic coverage• Presence oflymphangiosarcoma
Target Population /Intended Users	Patients who need venousreturn.	Patients who need venousreturn.	Patients who need venousreturn.	Identical
Where Used	Home, Hospital, SurgeryCenter, Altitude travel, areas oflimited mobility	Home, Hospital, SurgeryCenter, Altitude travel, areas oflimited mobility	Home, Hospital, SurgeryCenter, Altitude travel, areas oflimited mobility	Identical
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant	Identical
Basis of operation	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities.	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities.	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower extremities.	Identical
Anatomical Site /Location of treatmentapplication	Lower extremities	Lower extremities	Lower extremities	Identical
System management	Electronic, microprocessorcontrolled	Electronic, microprocessorcontrolled	Electronic, microprocessorcontrolled	Identical
Pressure Source	Micro pump controlled byelectronic processor	Micro pump controlled byelectronic processor	Micro pump controlled byelectronic processor	Identical
Operating Mode	Continuous Operation	Continuous Operation	Continuous Operation	Identical
Working Pressure	Preset at 55 mmHg	Preset at 55 mmHg	Preset at 40 mmHg	Identical or similar. Theworking pressure of thesubject device isidentical to that of theprimary predicatedevice, and similar tothat of the predicatedevice. Therefore, itwill not raise any newissue of the safety oreffectiveness.
Cycle Time	Approximately 60 seconds	Approximately 60 seconds	Approximately 60 seconds	Identical
System diagnostics	Audible and visual alarmsprompt recognition of systemfaults	Audible and visual alarmsprompt recognition of systemfaults	Audible and visual alarmsprompt recognition of systemfaults	Identical
Air delivery frompump to cuff bladder	Via flexible plastic tube(s)connected to the air bladder.	Via flexible plastic tube(s)connected to the air bladder.	Via flexible plastic tube(s)connected to the air bladder.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Single Patient Use	Identical
Material Used	A single air bladder encased ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility compliance.	A single air bladder encased ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility compliance.	A single air bladder encased ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility compliance.	Identical
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Moderate	Identical
Dimensions	220x70x48.5 mm	116x65x19 mm	110x180x270 mm	Different. Thedifference ofdimensions does not
				change the productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Weight Approx.	0.38kg	0.23kg	2.3kg	Different. Thedifference of weightdoes not change theproduct performance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Temperature	+10 °C (50 °F) to +40 °C (104°F)	+10 °C (50 °F) to +40 °C (104°F)	+5 °C (41 °F) to +40 °C (104°F)	Identical or similar
Humidity	30%-75%	30%-75%	15%-93%	Identical or similar

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 or similar performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.

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 lower extremities, using a cycle time of approximately 60 seconds. Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the lower extremity relaxes without any compression.

Identical to the predicate device, the subject device has multiple and visual alarms built into the system, including low pressure alarms and low battery alarm. In addition, the inflatable wrap (cuff) is comprised of a single air bladder encased in a covering of soft, non-woven medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. The microprocessor and pump units are powered by an internal rechargeable battery, and can be connected to the main AC power adapter/charger while in use, allowing uninterrupted prolonged service.

The skin contact components and materials of the subject device are identical to those of the predicate device in formulation, suppliers, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Therefore, there is no issue or concern of biocompatibility.

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.

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 the 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

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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. 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).