The PlasmaFlight is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. This device can be used to:

Temporarily increase blood circulation in the treated areas;
Temporary relief of minor muscle aches and pains.

Device Description

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff 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 that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.

AI/ML Overview

The provided text describes the 510(k) summary for the device "PlasmaFlight," a portable inflatable tube massager. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through comparison of technical characteristics and compliance with voluntary standards, rather than extensive clinical efficacy studies with specific acceptance criteria and detailed performance claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement for ground truth, and MRMC studies are not present in this document. The document's purpose is to show equivalence and safety/effectiveness via design and performance testing against standards, not to prove clinical performance against new acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its safety and effectiveness relative to the predicate device.

Here's an attempt to answer your questions based on the provided text, indicating "Not explicitly stated" where the information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria for clinical performance or a reported device performance in terms of efficacy metrics (e.g., specific percentage increase in blood circulation, or reduction in pain levels). Instead, it focuses on demonstrating that the PlasmaFlight's specifications and functions are "Identical or similar" to the predicate device, thereby showing "Substantial Equivalence".

The "acceptance criteria" for this submission would implicitly be that the device's characteristics and performance, as demonstrated through non-clinical tests and comparison, do not raise new questions of safety or effectiveness compared to the predicate device.

Here's a table summarizing the comparisons (which serve as the basis for "acceptance" in a substantial equivalence claim):

Characteristic / "Acceptance Criteria" (via Equivalence)	Subject Device (PlasmaFlight) Specification	Primary Predicate Device (PowerPlay Muscle Massager) Specification	Equivalence Status
Intended Use	"Temporarily increase blood circulation in the treated areas; Temporary relief of minor muscle aches and pains."	"Temporarily increase blood circulation in the treated areas; Temporary relief of minor muscle aches and pains."	Identical
Prescription or OTC	OTC	OTC	Identical
Power Source(s)	5V DC power supply (100-240 VAC input) and 3.7V rechargeable battery	Not publicly available	Identical or similar. "The voltage difference of power supply used does not change the product performance or parameters, which does not raise any new issue of the safety or effectiveness."
Battery Charge Time	Approx. 2-5 hours	Not publicly available	Identical or similar. "The difference of charging time does not change the product performance or parameters, which does not raise any new issue of the safety or effectiveness."
Internal rechargeable batteries	Yes	Yes	Identical
Compliance with Voluntary Standards	Yes (ANSI AAMI ES60601-1, IEC 60601-1-2)	Yes	Identical (for listed types: Electrical Safety, Mechanical Safety, etc.)
Functions and Design	Simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs.	Simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs.	Identical to the Primary Predicate Device
Contraindications	Identical to primary predicate	Suspected, active or untreated: Neuropathy, deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, congestive heart failure, thrombophlebitis or an active infection. On a leg where wraps would interfere with conditions (vein ligation, gangrene, dermatitis, open wounds, etc.), insensitive to pain, where increased circulation is undesirable.	Identical
Target Population / Intended Users	Users who need temporary increase of blood circulation in the treated area and temporary relief of minor muscular aches and pains.	Users who need temporary increase of blood circulation in the treated area and temporary relief of minor muscular aches and pains.	Identical to the Primary Predicate Device
Where Used	Home, Altitude travel, areas of limited mobility	Home, Altitude travel, areas of limited mobility	Identical to the Primary Predicate Device
Application	Non-invasive / external	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Identical
Basis of Operation	Using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities.	Using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities.	Identical
Anatomical Site / Location of Treatment Application	Lower limb(s) (Calf)	Calf, ankle, knee, hip or shoulder	Identical on the calf
System Management	Microprocessor	Microprocessor	Identical
Pressure Source	Micro pump controlled by microprocessor	Micro pump controlled by microprocessor	Identical
Operating Modes	Two preset modes of 55mmHg	Not publicly available	Identical or similar. "The subject device has the compression pressure within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness."
Working Pressure	Preset at approximately 55 mmHg	Adjusted at 30 - 70 mmHg	Identical or similar. "The subject device has the compression pressure within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness."
Cycle Time	Approx. 60 seconds/leg (inflation + rest, deflation)	Approx. 30 - 60 seconds/leg (inflation + rest, deflation)	Identical or similar. "The subject device has the cycle time within the range of the primary predicate device, which does not raise any new issue of the safety or effectiveness."
System Diagnostics	Audible and visual alarms prompt recognition of system faults	Visual alarms prompt recognition of system faults	Identical (implies the subject device meets or exceeds the predicate's fault recognition)
Air delivery from pump to cuff bladder	Via flexible plastic tube(s) connected directly to the air bladder	Via flexible plastic 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	Air bladder chambers encased in a covering of soft and nonlatex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.	Air bladder chambers encased in a covering of soft and nonlatex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.	Identical or similar
Biocompatibility	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Identical
Dimensions	116x65x19mm	Not publicly available	Identical of similar. "The difference of dimensions does not raise any new issue of safety or effectiveness"
Weight	Approx. 0.23kg	Not publicly available	Identical or similar. "The difference of weight does not raise any new issue of safety or effectiveness"
Temperature	+10 °C (50 °F) to +40 °C (104 °F)	Not publicly available	Identical
Humidity	30%-75%	Not publicly available	Identical
Cleaning and Disinfecting	Specified cleaning instructions (soft cloth, soapy water/70% isopropyl alcohol, air dry)	Not publicly available	Identical or similar (compared to the PlasmaFlow, K160318)
Disposal	Instructions for electromechanical device disposal including circuit boards and rechargeable batteries; not in landfill, contact local recycle center or ManaMed, Inc.	Not publicly available	Identical or similar (compared to the PlasmaFlow, K160318)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The submission relies on "Non-Clinical Tests" (bench tests) and comparison to the predicate device, not a specific clinical test set involving human subjects to evaluate new performance metrics.
Data Provenance: Not applicable for clinical data. The "tests" mentioned are non-clinical (bench tests) and compliance with standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a 510(k) submission for a physical therapy device demonstrating substantial equivalence, not an AI/imaging device requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this document.

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. This is not an AI/imaging device, and no MRMC study was conducted or is relevant for this type of submission.

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

Not applicable. This is a physical therapy device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth," in the context of this submission, is effectively the established safety and effectiveness profile of the legally marketed predicate device and compliance with recognized voluntary standards for medical device safety and performance. There is no "ground truth" derived from expert consensus, pathology, or outcomes data for new clinical claims.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning/AI device, so there is no training set or associated ground truth.

Summary of the Study Proving Substantial Equivalence:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to the predicate) is primarily a comparative analysis of technical characteristics and non-clinical bench testing.

Non-Clinical Tests Performed:
- Design Validation and Conformance with Voluntary Standards:
  - ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)" - for electrical safety.
  - 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" - for electromagnetic compatibility.
- Bench Tests: Performed on physical requirements, electrical requirements, and performance requirements.
- Software Verification: Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (as the device uses a microprocessor).
Conclusion: The tests and comparison performed demonstrate that the PlasmaFlight is substantially equivalent to the predicate device, implying it is as safe and effective as the legally marketed predicate device. The minor differences noted (e.g., in power supply details, charging time, dimensions, weight, operating modes, working pressure, cycle time, cleaning, disposal) were deemed not to raise any new issues of safety or effectiveness.

Summary

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August 5, 2020

ManaMed, Inc. % Bill Dai, PhD Manager JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine. California 92620

Re: K200351

Trade/Device Name: PlasmaFlight Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: April 29, 2020 Received: May 7, 2020

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

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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 (OS) 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,

Amber Ballard, PhD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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) K200351

Device Name PlasmaFlight

Indications for Use (Describe)

· Temporarily increase blood circulation in the treated areas;
· Temporary relief of minor muscle aches and pains.

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

Submitter: ManaMed, Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Contact Person: Trevor Theriot Tel : 702-781-1117 Date of Preparation: 12/20/2019

2. Subject Device

Trade/Device Name: PlasmaFlight Common Name: Massager, Powered Inflatable Tube Regulation Medical Specialty: Physical Medicine Review Panel: Physical Medicine Product Code: IRP Regulation Number: 21 CFR 890.5650 Device Class: II Use: Over-The-Counter

3. Predicate device

Primary Predicate Device: PowerPlay Muscle Massager, PPRT-01 510(k) Number: K122154 Clearance Date: November 21, 2012 Submitter: Fig, LLC

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

4. Description of Subject Device

The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff 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 that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned

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off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.

5. Indications for Use

Temporarily increase blood circulation in the treated areas;
Temporary relief of minor muscle aches and pains.

6. Summary of Substantial Equivalence

Identical to that of the primary predicate device, the operational principle of the subject device is to simulate kneading and stroking of tissue by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. The primary predicate device and the subject device have the same Indications for Use, and both of them are for the Over-The-Counter use.

In addition, the subject device PlasmaFlight was originally named PlasmaFlow in the predicate/reference K160318. PlasmaFlight and PlasmaFlow are the same except the Indications for Use. Therefore, K160318 is listed as the predicate device for reference.

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/Reference Device	Equivalence
510(k) Number	K200351	K122154	K160318	N/A
Submitter	ManaMed, Inc.	Fig, LLC	ManaMed, Inc.	N/A
DeviceName/Model	PlasmaFlight	PowerPlay Muscle Massager,PPRT-01	PlasmaFlow	N/A
Intended Use	The PlasmaFlight is intended tobe an over-the-counter portableinflatable tube massage systemwhich simulates kneading andstroking of tissue with the handsby use of inflatable pressure cuffs.This device can be used to:Temporarily increaseblood circulation in the treatedareas;Temporary relief ofminor muscle aches and pains.	The PowerPlay model PPRT-01 isintended to be an over-the-counterportable inflatable tube massagesystem which simulates kneadingand stroking of tissue with thehands by use of inflatablepressure cuffs. This device can beused to:Temporarily increaseblood circulation in the treatedareas;Temporary relief ofminor muscle aches and pains.	The PlasmaFlow, model PF0001,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 (simulating musclecontractions). This device can beused to:Aid in the prevention ofDVT;Enhance bloodcirculation;Diminish post-operativepain and swelling;Reduce wound healingtime;Aid in the treatment and	Identical to thePrimary PredicateDevice
			venous stasis ulcers, arterial anddiabetic leg ulcers, chronicvenous insufficiency andreduction of edema in the lowerlimbs.The unit can also be used as anaid in the prophylaxis for DVT bypersons expecting to be stationaryfor long periods of time.
Prescription orOTC	OTC	OTC	Prescription	Identical to theprimary predicatedevice
Power Source(s)	5V DC power supply (100-240VAC input) and 3.7Vrechargeable battery	Not publicly available	5V DC power supply (100-240VAC input) and 3.7Vrechargeable battery	Identical or similar.The voltage differenceof power supply useddoes not change theproduct performanceor parameters, whichdoes not raise any newissue of the safety oreffectiveness.
Battery Charge	Takes approximately 2-5 hours(from depleted state).	Not publicly available	Takes approximately 4-5 hours(from depleted state).	Identical or similar.The difference ofcharging time does notchange the productperformance orparameters, whichdoes not raise any newissue of the safety oreffectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60 Hz,Output: 5 Vdc @ 1 Amp)	Not publicly available	Input: 100 - 240 Vac, 50 - 60 Hz,Output: 5 Vdc @ 1 Amp)	Identical or Similar.The voltage differenceof power supply useddoes not change theproduct performanceor parameters, whichdoes not raise any newissue of the safety oreffectiveness.
Internalrechargeablebatteries	Yes	Yes	Yes	Identical
Compliancewith VoluntaryStandards?	Yes	Yes	Yes	Identical
Electrical SafetyMechanicalSafety ChemicalSafety ThermalSafety RadiationSafety?	Yes	Yes	Yes	Identical
Functions anddesign	Simulates kneading and strokingof tissue with the hands by use ofinflatable pressure cuffs	Simulates kneading and strokingof tissue with the hands by use ofinflatable pressure cuffs	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the extremities.	Identical to theprimary predicatedevice
Contraindication(s)	The PlasmaFlight MUST NOT beused to treat the followingconditions: Persons withsuspected, active or untreated:deep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heart	The PowerPlay PPRT-01 mustnot be used by persons with thefollowing conditions:• Suspected, active or untreated:Neuropathy, deep veinthrombosis, ischemic vasculardisease, severe arteriosclerosis,pulmonary edema, congestive	The PlasmaFlow MUST NOT beused to treat the followingconditions: Persons withsuspected, active or untreated:deep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heart	Identical

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

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	failure, 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 are insensitiveto pain.Where increased venous orlymphatic return is undesirable.	heart failure, thrombophlebitis oran active infection;• On a leg where wraps wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg;• On extremities that areinsensitive to pain;• Where increased circulation isundesirable;	failure, 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 are insensitiveto pain.Where increased venous orlymphatic return is undesirable.
TargetPopulation /Intended Users	Users who need temporaryincrease of blood circulation inthe treated area and temporaryrelief of minor muscular achesand pains	Users who need temporaryincrease of blood circulation inthe treated area and temporaryrelief of minor muscular achesand pains	Patients who need venous return	Identical to theprimary predicatedevice
Where Used	Home, Altitude travel, areas oflimited mobility	Home, Altitude travel, areas oflimited mobility	Home, Hospital, Surgery Center,Altitude travel, areas of limitedmobility	Identical to theprimary predicatedevice
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant	Identical
Basis ofoperation	Using cyclic, intermittent,pneumatic pressure application(inflation followed by deflation)to compress the extremities	Using cyclic, intermittent,pneumatic pressure application(inflation followed by deflation)to compress the extremities	Using cyclic, intermittent,pneumatic pressure application(inflation followed by deflation)to compress the extremities	Identical
Anatomical Site/ Location oftreatmentapplication	Lower limb(s) (Calf)	Calf, ankle, knee, hip or shoulder	Lower limb(s) (Calf)	Identical on the calf
Systemmanagement	Microprocessor	Microprocessor	Microprocessor	Identical
Pressure Source	Micro pump controlled bymicroprocessor	Micro pump controlled bymicroprocessor	Micro pump controlled bymicroprocessor	Identical
OperatingModes	Two preset modes of 55mmHg	Not publicly available	Two preset modes of 55mmHg	Identical or similar.The subject device hasthe compressionpressure within therange of the primarypredicate device,which does not raiseany new issue of thesafety or effectiveness.
WorkingPressure	Preset at approximately 55 mmHg	Adjusted at 30 - 70 mmHg	Preset at approximately 55 mmHg	Identical or similar.The subject device hasthe compressionpressure within therange of the primarypredicate device,which does not raiseany new issue of thesafety or effectiveness.
Cycle Time	applicationSystemmanagement	The PlasmaFlight utilizesmicroprocessor controlled pumpsto deliver approximately 55mmHg of pressurized air tobladders that are attached to the		The PowerPlay utilizesmicroprocessor controlled pumpsto deliver approximately 30 - 70mmHg of pressurized air tobladders that are attached to the	The PlasmaFlow utilizesmicroprocessor controlled pumpsto deliver approximately 55mmHg of pressurized air tobladders that are attached to the	Identical or similar.The subject device hasthe cycle time withinthe range of theprimary predicate
Microprocessor	Microprocessor	Microprocessor	Microprocessor	Identical
Pressure Source	Micro pump controlled bymicroprocessor	Micro pump controlled bymicroprocessor	Micro pump controlled bymicroprocessor	Identical
OperatingModes	Two preset modes of 55mmHg	Not publicly available	Two preset modes of 55mmHg	Identical or similar.The subject device hasthe compressionpressure within therange of the primarypredicate device,which does not raiseany new issue of thesafety or effectiveness.
WorkingPressure	Preset at approximately 55 mmHg	Adjusted at 30 - 70 mmHg	Preset at approximately 55 mmHg	Identical or similar.The subject device hasthe compressionpressure within therange of the primarypredicate device,which does not raiseany new issue of thesafety or effectiveness.
Cycle Time	The PlasmaFlight utilizesmicroprocessor controlled pumpsto deliver approximately 55mmHg of pressurized air tobladders that are attached to theuser's lower limbs, using a cycletime of approximately 60	The PowerPlay utilizesmicroprocessor controlled pumpsto deliver approximately 30 - 70mmHg of pressurized air tobladders that are attached to theuser's lower limbs, using a cycletime of approximately 30 - 60	The PlasmaFlow utilizesmicroprocessor controlled pumpsto deliver approximately 55mmHg of pressurized air tobladders that are attached to thepatient's lower limbs, using acycle time of approximately 60	Identical or similar.The subject device hasthe cycle time withinthe range of theprimary predicatedevice, which does notraise any new issue of

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	seconds / leg. Each cycle consistsof inflation of a bladder, followedby a rest period during which thebladder deflates and the limbrelaxes without any compression.	seconds / leg. Each cycle consistsof inflation of a bladder, followedby a rest period during which thebladder deflates and the limbrelaxes without any compression.	seconds / leg. Each cycle consistsof inflation of a bladder, followedby a rest period during which thebladder deflates and the limbrelaxes without any compression.	the safety oreffectiveness.
Systemdiagnostics	Audible and visual alarms promptrecognition of system faults	Visual alarms prompt recognitionof system faults	Audible and visual alarms promptrecognition of system faults	Identical
Air deliveryfrom pump tocuff bladder	Via flexible plastic tube(s)connected directly to the airbladder	Via flexible plastic tube(s)connected directly to the airbladder	Via flexible plastic tube(s)connected directly to the airbladder	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	Air bladder chambers encased in acovering of soft and nonlatexmedical fabric or equivalentmedical material for increasedpatient comfort andbiocompatibility compliance.	Air bladder chambers encased in acovering of soft and nonlatexmedical fabric or equivalentmedical material for increasedpatient comfort andbiocompatibility compliance.	Air bladder chambers encased in acovering of soft and nonlatexmedical fabric or equivalentmedical material for increasedpatient comfort andbiocompatibility compliance.	Identical or similar
Fasteningbetween theplastic case andthe fabric wrap	Snap and screw	Snap and tubing	Snap and screw	Identical or similar
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Moderate	Identical
Dimensions	116x65x19mm	Not publicly available	116x65x19mm	Identical of similar.The difference ofdimensions does notraise any new issue ofsafety or effectiveness
Weight Approx.	0.23kg	Not publicly available	0.23kg	Identical or similar.The difference ofweight does not raiseany new issue ofsafety or effectiveness
Temperature	+10 °C (50 °F) to +40 °C (104 °F)	Not publicly available	+10 °C (50 °F) to +40 °C (104 °F)	Identical
Humidity	30%-75%	Not publicly available	30%-75%	Identical
Cleaning andDisinfecting	• Clean the outer surface of thepumpunit using a soft cloth, moistenedwith soapy water or 70%isopropyl alcohol.• Do not use abrasive or volatilecleaners.• Do not place cuffs in dryer.• NEVER remove the unit fromthe cuff.• Hand wash the exterior of thecuffs using a soft cloth, moistenedwith soapy water or 70%isopropyl alcohol and let air dry.• To ensure the unit IS completelydry prior to use, leave unit in theOFFcondition and disconnected fromthewall outlet for 30 minutes aftercleaning or disinfecting.	Not publicly available	• Clean the outer surface of thepumpunit using a soft cloth, moistenedwith soapy water or 70%isopropyl alcohol.• Do not use abrasive or volatilecleaners.• Do not place cuffs in dryer.• NEVER remove the unit fromthe cuff.• Hand wash the exterior of thecuffs using a soft cloth, moistenedwith soapy water or 70%isopropyl alcohol and let air dry.• To ensure the unit IS completelydry prior to use, leave unit in theOFFcondition and disconnected fromthewall outlet for 30 minutes aftercleaning or disinfecting.	Identical or similar
Disposal	This unit is an electromechanicaldevice that includes printedcircuit boards and rechargeablebatteries.Do not discard in landfill. Consultlocal county requirements forproper disposal instructions.Pump control units containrechargeable batteries. Do notdiscard the pump unit in regularwaste. Bring the unit to your localrecycle center or contactManaMed, Inc.	Not publicly available	This unit is an electromechanicaldevice that includes printedcircuit boards and rechargeablebatteries.Do not discard in landfill. Consultlocal county requirements forproper disposal instructions.Pump control units containrechargeable batteries. Do notdiscard the pump unit in regularwaste. Bring the unit to your localrecycle center or contactManaMed, Inc.	Identical or similar

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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 the minor 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 approximately 55 mmHg of pressurized air to the air bladder that is attached to the user's lower extremities. Each cycle consists of inflation of the air bladder, followed by a rest period during which the bladder deflates and relaxes without any compression.

Identical to the predicate device, the subject device has multiple 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 an air bladder chambers encased in a covering of soft and non-latex medical fabric 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".

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

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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

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).