Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a simple pneumatic system controlled by basic software and a pressure switch, with no mention of AI/ML terms, data sets, or complex algorithms.

Therapeutic

Yes.
The device is intended for "temporary relief of minor muscle aches and pains" and "temporary increase of blood circulation," which are therapeutic purposes for addressing symptoms and improving physiological function.

Diagnostic

No

The device is an over-the-counter portable inflatable tube massage system intended for temporary relief of minor muscle aches and pains and to temporarily increase blood circulation, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including an air pump unit, inflatable pressure cuffs, a plastic case housing components, an ON/OFF button, LED indicators/displays, and a port for a battery charger. While it mentions "system software," the core functionality relies on these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the PlasmaFlight is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
PlasmaFlight's Function: The PlasmaFlight is a physical device that applies external pressure to the body using inflatable cuffs. Its intended use is to temporarily increase blood circulation and relieve muscle aches and pains through physical massage. It does not analyze any biological specimens.

The description clearly indicates a physical therapy/massage device, not a device for analyzing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

IRP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lower limb(s) (Calf)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Users who need temporary increase of blood circulation in the treated area and temporary relief of minor muscular aches and pains.
Home, Altitude travel, areas of limited mobility

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122154, K160318

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K160318

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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

2

Indications for Use

510(k) Number (if known) K200351

Device Name PlasmaFlight

Indications for Use (Describe)

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.

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 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

4

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

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.

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
Device
Name/Model	PlasmaFlight	PowerPlay Muscle Massager,
PPRT-01	PlasmaFlow	N/A
Intended Use	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.	The PowerPlay model PPRT-01 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.	The PlasmaFlow, model PF0001,
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 (simulating 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	Identical to the
Primary Predicate
Device
			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.
Prescription or
OTC	OTC	OTC	Prescription	Identical to the
primary predicate
device
Power Source(s)	5V DC power supply (100-240
VAC input) and 3.7V
rechargeable battery	Not publicly available	5V DC power supply (100-240
VAC input) and 3.7V
rechargeable battery	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	Takes approximately 2-5 hours
(from depleted state).	Not publicly available	Takes approximately 4-5 hours
(from depleted state).	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.
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 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.
Internal
rechargeable
batteries	Yes	Yes	Yes	Identical
Compliance
with Voluntary
Standards?	Yes	Yes	Yes	Identical
Electrical Safety
Mechanical
Safety Chemical
Safety Thermal
Safety Radiation
Safety?	Yes	Yes	Yes	Identical
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	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the extremities.	Identical to the
primary predicate
device
Contraindication
(s)	The PlasmaFlight MUST NOT be
used to treat the following
conditions: Persons with
suspected, active or untreated:
deep vein thrombosis, ischemic
vascular disease, severe
arteriosclerosis, pulmonary
edema, severe congestive heart	The PowerPlay PPRT-01 must
not be used by persons with the
following conditions:
• Suspected, active or untreated:
Neuropathy, deep vein
thrombosis, ischemic vascular
disease, severe arteriosclerosis,
pulmonary edema, congestive	The PlasmaFlow MUST NOT be
used to treat the following
conditions: Persons with
suspected, active or untreated:
deep vein thrombosis, ischemic
vascular disease, severe
arteriosclerosis, pulmonary
edema, severe congestive heart	Identical

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

5

6

| | 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. | heart failure, thrombophlebitis or
an active infection;
• On a leg where wraps 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 extremities that are
insensitive to pain;
• Where increased circulation is
undesirable; | 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 | 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 | Patients who need venous return | Identical to the
primary predicate
device | | | | | |
| Where Used | Home, Altitude travel, areas of
limited mobility | Home, Altitude travel, areas of
limited mobility | Home, Hospital, Surgery Center,
Altitude travel, areas of limited
mobility | Identical to the
primary predicate
device | | | | | |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical | | | | | |
| Portability | Portable, ambulant | 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 | 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 | Lower limb(s) (Calf) | Identical on the calf | | | | | |
| System
management | Microprocessor | Microprocessor | Microprocessor | Identical | | | | | |
| Pressure Source | Micro pump controlled by
microprocessor | Micro pump controlled by
microprocessor | Micro pump controlled by
microprocessor | Identical | | | | | |
| Operating
Modes | Two preset modes of 55mmHg | Not publicly available | Two preset modes of 55mmHg | 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 | Preset at approximately 55 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 | application
System
management | The PlasmaFlight utilizes
microprocessor controlled pumps
to deliver approximately 55
mmHg of pressurized air to
bladders that are attached to the | | The PowerPlay utilizes
microprocessor controlled pumps
to deliver approximately 30 - 70
mmHg of pressurized air to
bladders that are attached to the | | The PlasmaFlow utilizes
microprocessor controlled pumps
to deliver approximately 55
mmHg of pressurized air to
bladders that are attached to the | | Identical or similar.
The subject device has
the cycle time within
the range of the
primary predicate | |
| Microprocessor | Microprocessor | Microprocessor | Microprocessor | Identical | | | | | |
| Pressure Source | Micro pump controlled by
microprocessor | Micro pump controlled by
microprocessor | Micro pump controlled by
microprocessor | Identical | | | | | |
| Operating
Modes | Two preset modes of 55mmHg | Not publicly available | Two preset modes of 55mmHg | 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 | Preset at approximately 55 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 | The PlasmaFlight utilizes
microprocessor controlled pumps
to deliver approximately 55
mmHg of pressurized air to
bladders that are attached to the
user's lower limbs, using a cycle
time of approximately 60 | The PowerPlay utilizes
microprocessor controlled pumps
to deliver approximately 30 - 70
mmHg of pressurized air to
bladders that are attached to the
user's lower limbs, using a cycle
time of approximately 30 - 60 | The PlasmaFlow utilizes
microprocessor controlled pumps
to deliver approximately 55
mmHg of pressurized air to
bladders that are attached to the
patient's lower limbs, using a
cycle time of approximately 60 | 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 | | | | | |

7

| | 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. | 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. | 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. | the safety or
effectiveness. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| System
diagnostics | Audible and visual alarms prompt
recognition of system faults | 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 directly to the air
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 | Clean / non-sterile | Identical |
| Leg cuff usage | Single Patient Use | 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. | 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 |
| Fastening
between the
plastic case and
the 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 of
dimensions does not
raise any new issue of
safety or effectiveness |
| Weight Approx. | 0.23kg | Not publicly available | 0.23kg | 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 | +10 °C (50 °F) to +40 °C (104 °F) | Identical |
| Humidity | 30%-75% | Not publicly available | 30%-75% | Identical |
| Cleaning and
Disinfecting | • Clean the outer surface of the
pump
unit using a soft cloth, moistened
with soapy water or 70%
isopropyl alcohol.
• Do not use abrasive or volatile
cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from
the cuff.
• Hand wash the exterior of the
cuffs using a soft cloth, moistened
with soapy water or 70%
isopropyl alcohol and let air dry.
• To ensure the unit IS completely
dry prior to use, leave unit in the
OFF
condition and disconnected from
the
wall outlet for 30 minutes after
cleaning or disinfecting. | Not publicly available | • Clean the outer surface of the
pump
unit using a soft cloth, moistened
with soapy water or 70%
isopropyl alcohol.
• Do not use abrasive or volatile
cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from
the cuff.
• Hand wash the exterior of the
cuffs using a soft cloth, moistened
with soapy water or 70%
isopropyl alcohol and let air dry.
• To ensure the unit IS completely
dry prior to use, leave unit in the
OFF
condition and disconnected from
the
wall outlet for 30 minutes after
cleaning or disinfecting. | Identical or similar |
| Disposal | This unit is an electromechanical
device that includes printed
circuit boards and rechargeable
batteries.
Do not discard in landfill. Consult
local county requirements for
proper disposal instructions.
Pump control units contain
rechargeable batteries. Do not
discard the pump unit in regular
waste. Bring the unit to your local
recycle center or contact
ManaMed, Inc. | Not publicly available | This unit is an electromechanical
device that includes printed
circuit boards and rechargeable
batteries.
Do not discard in landfill. Consult
local county requirements for
proper disposal instructions.
Pump control units contain
rechargeable batteries. Do not
discard the pump unit in regular
waste. Bring the unit to your local
recycle center or contact
ManaMed, Inc. | Identical or similar |

8

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

9

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.