K Number

Device Name

PlasmaWave

Manufacturer

ManaMed, Inc.

Date Cleared

2021-05-26

(30 days)

Product Code

JOW

Regulation Number

870.5800

Intended Use

The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to: - · Aid in the prevention of DVT; - · Enhance blood circulation: - · Diminish post-operative pain and swelling; - · Reduce wound healing time; - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Device Description

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K160318, K141578

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on pneumatic control, electronic components, and standard electrical/software safety testing, with no mention of AI/ML algorithms or data-driven decision making.

Therapeutic

Yes
The device is described as aiding in the prevention and treatment of various medical conditions, including DVT, post-operative pain and swelling, and chronic venous insufficiency.

Diagnostic

No.
The device's intended use and description clearly state it is for prevention and treatment (e.g., aid in prevention of DVT, diminish pain, enhance circulation), not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "lightweight, portable, rechargeable battery powered prescriptive device" that utilizes "pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing." This clearly indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD devices are used to examine specimens from the human body. The PlasmaWave's description and intended use clearly indicate it is a physical device that applies pneumatic pressure to the lower extremities to stimulate blood flow. It does not analyze blood, tissue, or any other biological sample.
The intended use focuses on physical therapy and prevention. The listed uses like preventing DVT, enhancing blood circulation, and reducing swelling are all related to physical manipulation and support of the circulatory system, not diagnostic testing.
The device description details a mechanical system. The description of the air pump, solenoid valve, tubing, and inflatable wraps points to a device that provides external physical therapy.

Therefore, the PlasmaWave falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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.

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

JOW

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lower extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home, Hospital, Surgery Center, 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 the medical device electrical safety, and electromagnetic compatibility.

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

K160318, K141578

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.

Not Found

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

§ 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).

Summary

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

May 26, 2021

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

Re: K211253

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

Dear Dr. Dai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K211253

Device Name PlasmaWave

Indications for Use (Describe)

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

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

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter's Information

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

2. Subject Device

Trade/Device Name: PlasmaWave Regulation Description: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

3. Predicate device

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

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

4. Description of Subject Device

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

	Subject Device	Primary Predicate Device	Predicate Device	Equivalence
510(k) Number	N/A	K160318	K141578	N/A
Submitter	ManaMed, Inc.	ManaMed, Inc.	Devon Medical, Inc.	N/A
Device Name/Model	PlasmaWave	PlasmaFlow	Cirona 6200 Deep Vein
Thrombosis Prevention System	N/A
Intended Use	The PlasmaWave is intended to
be an easy to use portable
system, prescribed by a
physician, for use in the home
or clinical setting to help
prevent the onset of DVT in
patients by stimulating blood
flow in the extremities
(stimulating muscle
contractions). This device can
be used to:
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.	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 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.	The Cirona 6200 Series system
is a prescription device
intended to be used
preventatively to increase
venous blood flow in patients
at risk of deep vein
thrombosis due to the
associated risk factors for
thrombus formation during:
trauma, critical care, general
medicine, general surgery, as
well as neurological,
orthopedic, urologic, obstetric
conditions and treatments.	Identical
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Identical
Battery Specifications	3.7V rechargeable battery	3.7V rechargeable battery	10.8V rechargeable battery	Identical or similar. The
voltage difference of
batteries will not raise
any new issue of the
safety or effectiveness.
Battery Charge	Takes approximately 4 hours
(from depleted state).	Takes approximately 4 hours
(from depleted state).	Takes approximately 5 hours
(from depleted state).	Identical or similar. The
difference of charging
time does not change
the product
performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 12 Vdc @ 2 A	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 5 Vdc @ 1 A	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 14 Vdc @ 2 A	Similar. The voltage
difference of power
supply used does not
change the product
performance or
parameters, which will
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	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities.	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities.	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities	Identical
Contraindication(s)	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
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.	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
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.	The Cirona 6200 Series system
should NOT be used in the
following conditions:
· Severe atherosclerosis or
other ischemic vascular
diseases
• Suspected or known acute
deep vein thrombosis
• Severe congestive cardiac
failure
• Existing pulmonary edema
• Existing pulmonary
embolisms
• Extreme deformity of the
limbs
• Any local skin or tissue
condition in which the
garments would interfere:
· Gangrene
• Untreated or infected wounds
· Recent skin graft
· Dermatitis
• Known presence of
malignancy in the legs	Identical
			• Limb infections, including
cellulitis, that have not received
antibiotic coverage
• Presence of
lymphangiosarcoma
Target Population /
Intended Users	Patients who need venous
return.	Patients who need venous
return.	Patients who need venous
return.	Identical
Where Used	Home, Hospital, Surgery
Center, Altitude travel, areas of
limited mobility	Home, Hospital, Surgery
Center, Altitude travel, areas of
limited mobility	Home, Hospital, Surgery
Center, Altitude travel, areas of
limited mobility	Identical
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external	Identical
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant	Identical
Basis of operation	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities.	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities.	Aids venous return by using
cyclic, intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower extremities.	Identical
Anatomical Site /
Location of treatment
application	Lower extremities	Lower extremities	Lower extremities	Identical
System management	Electronic, microprocessor
controlled	Electronic, microprocessor
controlled	Electronic, microprocessor
controlled	Identical
Pressure Source	Micro pump controlled by
electronic processor	Micro pump controlled by
electronic processor	Micro pump controlled by
electronic processor	Identical
Operating Mode	Continuous Operation	Continuous Operation	Continuous Operation	Identical
Working Pressure	Preset at 55 mmHg	Preset at 55 mmHg	Preset at 40 mmHg	Identical or similar. The
working pressure of the
subject device is
identical to that of the
primary predicate
device, and similar to
that of the predicate
device. Therefore, it
will not raise any new
issue of the safety or
effectiveness.
Cycle Time	Approximately 60 seconds	Approximately 60 seconds	Approximately 60 seconds	Identical
System diagnostics	Audible and visual alarms
prompt recognition of system
faults	Audible and visual alarms
prompt recognition of system
faults	Audible and visual alarms
prompt recognition of system
faults	Identical
Air delivery from
pump to cuff bladder	Via flexible plastic tube(s)
connected to the air bladder.	Via flexible plastic tube(s)
connected to the air bladder.	Via flexible plastic tube(s)
connected to the air bladder.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Single Patient Use	Identical
Material Used	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	Identical
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Moderate	Identical
Dimensions	220x70x48.5 mm	116x65x19 mm	110x180x270 mm	Different. The
difference of
dimensions does not
				change the product
performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Weight Approx.	0.38kg	0.23kg	2.3kg	Different. The
difference of weight
does not change the
product performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Temperature	+10 °C (50 °F) to +40 °C (104
°F)	+10 °C (50 °F) to +40 °C (104
°F)	+5 °C (41 °F) to +40 °C (104
°F)	Identical or similar
Humidity	30%-75%	30%-75%	15%-93%	Identical or similar

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

7. Substantial Equivalence

As shown in the above table of comparison, the subject device in this submission has the identical or similar performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.

The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver pressurized air to bladders that are attached to the patient's lower extremities, using a cycle time of approximately 60 seconds. Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the lower extremity relaxes without any compression.

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

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

The subject device is designed for the same intended use as the predicated device. The comparison of the specifications demonstrates the functional equivalence of the products, concluding that the subject device is substantially equivalent to the predicate device.

8. Non-Clinical Tests Performed

(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".

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.