The VenaPro Vascular Therapy System 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:

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 VenaPro Vascular Therapy System 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 system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reporting.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs (1 left and 1 right side).

In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VenaPro Vascular Therapy System, arguing for its substantial equivalence to a previously cleared predicate device (K133274). The document does not describe a study involving human readers or AI assistance, nor does it specify acceptance criteria for clinical performance. Instead, it focuses on non-clinical testing and a comparison of the device's technical characteristics with its predicate.

Therefore, many of the requested pieces of information are not present in the provided document.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for clinical performance. Instead, it focuses on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing. The "performance" reported is primarily that the subject device meets the same specifications, functions, and safety standards as the predicate.

Feature/Criterion	Predicate Device (K133274) Performance	Subject Device Performance	Equivalence Notes
Intended Use	Aid in DVT prevention, enhance blood circulation, diminish post-operative pain/swelling, reduce wound healing time, aid in treatment/healing of various ulcers/edema, DVT prophylaxis.	Aid in DVT prevention, enhance blood circulation, diminish post-operative pain/swelling, reduce wound healing time, aid in treatment/healing of various ulcers/edema, DVT prophylaxis.	Identical
Prescription/OTC	Prescription	Prescription	Identical
Power Source	Rechargeable battery	Rechargeable battery	Identical
Battery Specifications	7.4V rechargeable battery	3.7V rechargeable battery	The voltage difference does not change product performance or parameters and does not raise new safety/effectiveness issues.
Battery Charge Time	~1.5 hours (from depleted)	~2.5 hours (from depleted)	The difference in charging time does not change product performance or parameters and does not raise new safety/effectiveness issues.
Power Supply (Charger)	Input: 100-240 Vac, Output: 10 Vdc @ 1.1 Amp	Input: 100-240 Vac, Output: 5 Vdc @ 1 Amp	The voltage difference of the power supply (to match the changed battery) does not change product performance or parameters and does not raise new safety/effectiveness issues.
Functions and Design	Aids venous return via cyclic, intermittent pneumatic pressure (inflation/deflation) to compress lower limb(s).	Aids venous return via cyclic, intermittent pneumatic pressure (inflation/deflation) to compress lower limb(s).	Identical
Working Pressure	Default 50 mmHg	Default 50 mmHg	Identical
Cycle Time	60 seconds	60 seconds	Identical
System Diagnostics (Alarms)	Audible/visual alarms for faults (low pressure, low battery, overpressure)	Audible/visual alarms for faults (low pressure, low battery, overpressure)	Identical
Cuff Material	Single bladder PVC chambers, non-latex, non-woven medical fabric (Polyester blend)	Single bladder PVC chambers, non-latex, non-woven medical fabric (Polyester blend)	Identical or similar (predicate specified "or equivalent")
Fastening (Plastic case & fabric wrap)	Glue	Snap and screw	The new fastening method (snap and screw) is hidden and does not raise new safety/effectiveness issues.
Biocompatibility	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Identical
Dimensions	131x66x37mm	131x66x37mm	Identical or similar
Weight	~0.23kg	~0.23kg	Identical or similar
Temperature (Operating)	+10 °C to +40 °C	+10 °C to +40 °C	Identical
Humidity (Operating)	30%-75%	30%-75%	Identical
Tolerances (Pressure)	5%	5%	Identical
Cleaning/Disinfecting	Specified procedures	Specified procedures	Identical
Disposal	Specified procedures	Specified procedures	Identical

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

Not applicable/Not provided. This submission is for a medical device (compressible limb sleeve system) where substantial equivalence is demonstrated through comparison of technical specifications and non-clinical engineering tests, not a clinical study involving a "test set" of patient data for performance evaluation in the context of an AI device.

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

Not applicable/Not provided. As above, no clinical "test set" requiring expert ground truth was described for this type of device submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical "test set" requiring adjudication was described.

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

Not applicable/Not provided. This document concerns a physical medical device (VenaPro Vascular Therapy System), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI assistance comparison was performed.

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

Not applicable/Not provided. This is not an AI device.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/software performance in image interpretation or diagnosis is not relevant here. The "truth" for this submission is based on adherence to engineering standards and technical specifications proven safe and effective by the predicate device.

Specifically, non-clinical tests were performed to assure conformance with:

ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
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".
IEC 60601-1-11 "Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment".
IEC 62133-2 "Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems".
Bench tests for physical, electrical, and performance requirements.
Software verification according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device.

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

Not applicable/Not provided. This is not an AI device.

Summary

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

December 4, 2019

Innovamed Health, LLC % Bill Dai Manager Jkh Usa, LLC 20505 Valley Blvd. Suite 108 Walnut, California 91789

Re: K193020

Trade/Device Name: VenaPro Vascular Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: October 26, 2019 Received: October 30, 2019

Dear Bill Dai:

We have reviewed vour 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/cfpmp/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

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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 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 (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,

Fernando Aguel 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) K193020

Device Name VenaPro Vascular Therapy System

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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1. Submitter's Information

Submitter: Innovamed Health, LLC Address: 270 West 500 North North Salt Lake, UT 84054 Contact Person: Luke Zeutzius Email: Luke@InnovamedHealth.com Date of Preparation: 09/30/2019

2. Subject Device

Trade/Device Name: VenaPro Vascular Therapy System Common Name: Compressible Limb Sleeve Device Regulation Medical Specialty: Neurology Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

3. Predicate device

Trade Name: VenaPro Vascular Therapy System 510(k) Number: K133274 Clearance Date: February 12, 2014 Submitter: Innovamed Health, LLC

4. Description of Subject Device

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the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.

5. Indications for Use

Prescription Use:

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 modified subject device and the original predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

	Subject Device	Predicate Device	Equivalence
510(k) Number	N/A	K133274
Submitter	Innovamed Health, LLC	Innovamed Health, LLC	Identical
Device Name/Model	VenaPro Vascular Therapy System	VenaPro Vascular Therapy System	Identical
Intended Use	Prescription Use:	Prescription Use:	Identical
	The VenaPro Vascular TherapySystem is intended to be an easy to useportable system, prescribed by aphysician, for use in the home orclinical setting to help prevent theonset of DVT in patients bystimulating blood flow in theextremities (stimulating musclecontractions). This device can be usedto:• Aid in the prevention ofDVT;• Enhance blood circulation;• Diminish post-operative painand swelling;• Reduce wound healing time;• Aid in the treatment andhealing of stasis dermatitis,venous stasis ulcers, arterial	The VenaPro Vascular TherapySystem is intended to be an easy to useportable system, prescribed by aphysician, for use in the home orclinical setting to help prevent theonset of DVT in patients bystimulating blood flow in theextremities (stimulating musclecontractions). This device can be usedto:• Aid in the prevention ofDVT;• Enhance blood circulation;• Diminish post-operative painand swelling;• Reduce wound healing time;• Aid in the treatment andhealing of stasis dermatitis,venous stasis ulcers, arterial

	and diabetic leg ulcers,chronic venous insufficiencyand reduction of edema inthe lower limbs.The unit can also be used as an aid inthe prophylaxis for DVT by personsexpecting to be stationary for longperiods of time.	and diabetic leg ulcers,chronic venous insufficiencyand reduction of edema inthe lower limbs.The unit can also be used as an aid inthe prophylaxis for DVT by personsexpecting to be stationary for longperiods of time.
Prescription or OTC	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Identical
Battery Specifications	3.7V rechargeable battery	7.4V rechargeable battery	The predicate device uses the7.4V rechargeable battery. Incomparison, the subject deviceswitches to the 3.7Vrechargeable battery. Thevoltage difference of batteriesused does not change theproduct performance orparameters, which will not raiseany new issue of the safety oreffectiveness.
Battery Charge	Takes approximately 2.5 hours (fromdepleted state).	Takes approximately 1.5 hours (fromdepleted state).	The difference of charging timedoes not change the productperformance or parameters,which will not raise any newissue of the safety oreffectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60 Hz,Output: 5 Vdc @ 1 Amp)	Input: 100 - 240 Vac, 50 - 60 Hz,Output: 10 Vdc @ 1.1 Amp)	The predicate device uses the7.4V rechargeable battery that ischarged by a 10V charger. Incomparison, the subject deviceswitches to the 3.7Vrechargeable battery, which ischarged by a 5V charger. Thevoltage difference of powersupply used does not change theproduct performance orparameters, which will not raiseany new issue of the safety oreffectiveness.
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 pressureapplication (inflation followed bydeflation) to compress the lowerlimb(s).	Aids venous return by using cyclic,intermittent, pneumatic pressureapplication (inflation followed bydeflation) to compress the lowerlimb(s).	Identical
Contraindication(s)	The VenaPro Vascular TherapySystem MUST NOT be used to treatthe following conditions: Persons withsuspected, active or untreated: deepvein thrombosis, ischemic vasculardisease, severe arteriosclerosis,pulmonary edema	The VenaPro Vascular TherapySystem MUST NOT be used to treatthe following conditions: Persons withsuspected, active or untreated: deepvein thrombosis, ischemic vasculardisease, severe arteriosclerosis,pulmonary edema	Identical

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

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	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.	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.
Target Population /Intended Users	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	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 lower limb(s).	Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s).	Identical
Anatomical Site /Location of treatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Identical
System management	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Identical
Pressure Source	Micro pump controlled by electronic processor	Micro pump controlled by electronic processor	Identical
Operating Modes	Default mode one	Default mode one	Identical
Working Pressure	Default mode is preset at 50 mmHg	Default mode is preset at 50 mmHg	Identical
Cycle Time	60 seconds	60 seconds	Identical
System diagnostics	Audible and visual alarms prompt recognition of system faults	Audible and visual alarms prompt recognition of system faults	Identical
Modes	1 Modality	1 Modality	Identical
Air delivery from pumpto cuff bladder	Via flexible plastic (PVC) tube(s) connected directly to the air bladder.	Via flexible plastic (PVC) tube(s) connected directly to the air bladder.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Identical
Material Used		Single bladder PVC chambers encased in a covering of soft, nonlatex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and	for increased patient comfort andbiocompatibility compliance.	Single bladder PVC chambers encased in a covering of soft, nonlatex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and	for increased patient comfort andbiocompatibility compliance.	Identical or similar
		Glue
Fastening between theplastic case and thefabric wrap	Snap and screw	Glue	The plastic case and the fabricwrap of the predicate device areglued together, while the plasticcase and the fabric wrap of thesubject device are snapped andscrewed together. The patientscan not reach the snap and

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			screws that are hidden in thesubject device. Therefore, thisdifference will not raise any new
			issue of safety and effectiveness.
Biocompatibility	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Identical
Dimensions	131x66x37mm	131x66x37mm	Identical of similar
Weight Approx.	0.23kg	0.23kg	Identical or similar
Temperature	+10 °C (50 °F) to +40 °C (104 °F)	+10 °C (50 °F) to +40 °C (104 °F)	Identical
Humidity	30%-75%	30%-75%	Identical
Tolerances	Pressure 5%	Pressure 5%	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 volatilecleaners.• Do not place cuffs in dryer.• NEVER remove the unit from thecuff.• Hand wash the exterior of the cuffsusing a soft cloth, moistened withsoapy water or 70% isopropyl alcoholand let air dry.• To ensure the unit IS completely dryprior to use, leave unit in the OFFcondition and disconnected from thewall outlet for 30 minutes aftercleaning or disinfecting.	• Clean the outer surface of the pumpunit using a soft cloth, moistened withsoapy water or 70% isopropyl alcohol.• Do not use abrasive or volatilecleaners.• Do not place cuffs in dryer.• NEVER remove the unit from thecuff.• Hand wash the exterior of the cuffsusing a soft cloth, moistened withsoapy water or 70% isopropyl alcoholand let air dry.• To ensure the unit IS completely dryprior to use, leave unit in the OFFcondition and disconnected from thewall outlet for 30 minutes aftercleaning or disinfecting.	Identical
Disposal	This unit is an electromechanicaldevice that includes printed circuitboards and rechargeable batteries.Do not discard in landfill. Consultlocal county requirements for properdisposal instructions. Pump controlunits contain rechargeable batteries.Do not discard the pump unit inregular waste. Bring the unit to yourlocal recycle center or contactInnovamed Health, LLC.	This unit is an electromechanicaldevice that includes printed circuitboards and rechargeable batteries.Do not discard in landfill. Consultlocal county requirements for properdisposal instructions. Pump controlunits contain rechargeable batteries.Do not discard the pump unit inregular waste. Bring the unit to yourlocal recycle center or contactInnovamed Health, LLC.	Identical

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 in K133274. The updated and optimized circuit board in the subject device does not change any product performance. And the differences between the modified subject device and the original (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 approximately 50 mmHg of pressurized air to bladders that are attached to the patient's lower limbs, using a cycle time of approximately 60 seconds/leg. Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the limb relaxes without any compression.

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Identical to the predicate device, the subject device has multiple audible and visual safety alarms built into the system, including low pressure alarms, low battery alarm and system malfunction overpressure safety alarm. In addition, the cuff is comprised of single bladder PVC chambers encased in a covering of soft, non-latex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and biocompatibility compliance. 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.

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 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".
(c) IEC 60601-1-11 "Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment".
(d) IEC 62133-2 "Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems".

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).