Who is the manufacturer of ManaFlow?

Manamed, Inc. filed the 510(k) submission for ManaFlow (K200353).

What is the FDA product code for ManaFlow?

JOW. It is classified under 21 CFR 870.5800 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ManaFlow?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ManaFlow?

ACTitouch™ Adaptive Compression Therapy system (K131193); PlasmaFlow (K160318); medi pneumatic compression system (pcs) - brio (Model 651) (K183631); SC-3004FC-DL Sequential Circulator (K142640).

Who can help prepare an FDA 510(k) submission like ManaFlow?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ManaFlow

K200353 · Manamed, Inc. · JOW · Aug 6, 2020 · Cardiovascular

Device Facts

Record ID	K200353
Device Name	ManaFlow
Applicant	Manamed, Inc.
Product Code	JOW · Cardiovascular
Decision Date	Aug 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5800
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: - Treatment of lymphedema - Treatment of chronic venous insufficiency - Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers - Reducing venous leg ulcer healing time - Reducing edema due to venous stasis - Enhancing venous return The device is intended for home, and hospital use.

Device Story

ManaFlow is a portable, rechargeable, prescription-only intermittent pneumatic compression system for home and hospital use. It consists of a control unit with an air pump and an inflatable sleeve with multiple air chambers. The device is operated by a physician or patient; the user initiates the cycle via an ON/OFF button. The system inflates the cuff to a default (50 mmHg) or physician-adjusted pressure, then deflates to ambient pressure during a rest period. This cyclic inflation/deflation mimics muscle contractions to enhance venous return, treat lymphedema, and reduce edema. The control unit monitors pressure via an internal switch and software, providing audible and visual alarms for system faults. The output is mechanical compression of the limb, which aids in blood circulation and promotes healing of venous ulcers. The device benefits patients by providing portable, automated compression therapy to manage edematous conditions and prevent DVT.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification per FDA guidance.

Technological Characteristics

Portable, rechargeable electromechanical device. Components: plastic-housed control unit, inflatable multi-chamber cuff (soft medical fabric). Sensing: internal pressure switch. Energy: internal rechargeable battery or AC adapter. Connectivity: standalone. Sterilization: supplied clean, non-sterile. Software: microprocessor-controlled pump cycles. Biocompatible materials.

Indications for Use

Indicated for patients requiring venous return and lymphedema treatment, including chronic venous insufficiency, stasis dermatitis, venous stasis ulcers, and edema due to venous stasis. Contraindicated for patients with suspected/active/untreated deep vein thrombosis (DVT), ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, or on legs where cuffs interfere with conditions like gangrene, open wounds, or recent skin grafts.

Regulatory Classification

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.

Predicate Devices

ACTitouch™ Adaptive Compression Therapy system (K131193)
PlasmaFlow (K160318)
medi pneumatic compression system (pcs) - brio (Model 651) (K183631)
SC-3004FC-DL Sequential Circulator (K142640)

Related Devices

K240011 — Lymphedema Compression · Jkh Health Co., Ltd. · Feb 23, 2024
K212731 — Circul8 Pro · Ortho8, Inc. · Nov 15, 2021
K130174 — DVTCARE CA5 · Ossur Americas, Inc. · May 2, 2013
K103187 — TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM · Wildcat Medical, Inc. · Jan 26, 2011
K203310 — SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System · Jiangsu Synecoun Medical Technology Co., Ltd. · Apr 2, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 6, 2020 ManaMed, Inc Bill Dai Consultant 14271 Jeffrey Rd. #246 Irvine, California 92620 Re: K200353 Trade/Device Name: ManaFlow Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 3, 2020 Received: July 7, 2020 #### Dear Bill 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 {1}------------------------------------------------ 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 medical devices and radiation-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, for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200353 Device Name ManaFlow #### Indications for Use (Describe) The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: - · Treatment of lymphedema - · Treatment of chronic venous insufficiency - · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers - · Reducing venous leg ulcer healing time - · Reducing edema due to venous stasis - Enhancing venous return The device is intended for home, and hospital use. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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: ManaFlow Common Name: 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: ACTitouch™ Adaptive Compression Therapy system 510(k) Number: K131193 Clearance Date: June 18, 2013 Submitter: Tactile Systems Technology, Inc. Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed. Inc. Predicate Device: medi pneumatic compression system (pcs) - brio (Model 651) 510(k) Number: K183631 Clearance Date: January 25, 2019 Submitter: Medi USA, LP Predicate Device: SC-3004FC-DL Sequential Circulator 510(k) Number: K142640 Clearance Date: November 6, 2014 Submitter: Bio Compression Systems, Inc. #### 4. Description of Subject Device The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT). The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively {4}------------------------------------------------ housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance. In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off. ## 5. Indications for Use ## Prescription Use: The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: - Treatment of lymphedema - Treatment of chronic venous insufficiency - Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers - Reducing venous leg ulcer healing time - Reducing edema due to venous stasis - Enhancing venous return The device is intended for home, and hospital use. ## 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 | Predicate Device | Predicate Device | Equivalence | Prescription or OTC | numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: | Compression Therapy system provides graduated compression in both sustained and intermittent settings for use in: | 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: | (pcs)-brio is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: -Lymphedema -Venous stasis ulcers -Venous insufficiency -Peripheral edema The device is intended for home, and hospital use. | Systems' SC-3008- DL, SC-3004-DL, SC-3004FC-DL and SC-2008-DL pumps and associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. These devices are also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment for swelling of the extremities. The devices are intended for home or hospital use. | Identical | | | | | | | raise any new issue of the safety or effectiveness. | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------|------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K200353 | K131193 | K160318 | K183631 | K142640 | N/A | Prescription | Treatment of lymphedema Treatment of chronic venous insufficiency Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers Reducing venous leg ulcer healing time Reducing edema due to venous stasis Enhancing venous return The device is intended for home, and hospital use. | Enhancin g venous return Reducin g venous leg ulcer healing time Treatme nt and promotion of healing of stasis dermatitis and venous stasis ulcers Treatme nt of chronic venous insufficiency Reducin g edema due to venous stasis Treatme nt of lymphedema | 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. | Prescription | Prescription | Identical | Power Supply | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 5 Vdc @ 2 Amp) | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 7.5 Vdc @ 0.9 Amp) | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 5 Vdc @ 1 Amp) | 115V AC, 50-60Hz | 115V AC, 50-60Hz | Identical or 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. | | Submitter | ManaMed, Inc. | Tactile Systems Technology, Inc. | ManaMed, Inc. | Medi USA, LP | Bio Compression Systems, Inc. | N/A | Power Source(s) | 5V DC power supply (100-240 VAC input) and 3.7V rechargeable battery | 5V DC power supply (100-240 VAC input) and 3.7V rechargeable battery | 5V DC power supply (100-240 VAC input) and 3.7V rechargeable battery | 115V AC, 50-60Hz | 115V AC, 50-60Hz | Identical or similar | Internal rechargeable batteries | Yes | Yes | Yes | N/A | No | Identical | | Device Name/Model | ManaFlow | ACTitouchTM Adaptive Compression Therapy system | PlasmaFlow | medi pneumatic compression system (pcs) - brio (Model 651) | SC-3004FC-DL Sequential Circulator | N/A | Battery Charge | Takes approximately 4 hours (from depleted state). | Takes approximately 4 hours (from depleted state). | Takes approximately 2.5 hours (from depleted state). | N/A | N/A | Identical or similar. The difference of charging time does not change the product performance or parameters, which will not | Compliance with Voluntary Standards? | Yes | Yes | Yes | Yes | Yes | Identical | | Intended Use | The ManaFlow system, part | The ACTitouchTM Adaptive | The PlasmaFlow, model PF0001, is | The medi pneumatic compression system | The Bio Compression | Identical | Electrical Safety Mechanical Safety Chemical Safety Thermal Safety Radiation Safety? | Yes | Yes | Yes | Yes | Yes | Identical | | | | | | | | | Functions and design | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities. | Identical | | | | | | | | | | | | | | | | Contraindication (s) | 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. | The ACTitouch System is contraindicated if the patient has: • An Ankle Brachial Pressure Index of less than 0.8; • Diagnosed or suspected acute Deep Vein Thrombosis (DVT) or pulmonary embolism; • Pulmonary edema; • Leg gangrene; • Acute thrombophlebitis; • Decompensated /Congestive Cardiac Failure; • Severe arteriosclerosis or other ischemic vascular disease; • Diabetes in | 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. | Contraindicated for patients with acute Deep Vein Thrombosis. | Compression IS NOT recommended in the following conditions: • Infections in the limb, including cellulitis without appropriate antibiotic coverage • The presence of lymphangiosarcoma • Deep vein thrombosis (DVT) • Inflammatory phlebitis or episodes of pulmonary embolism • Congestive heart failure (CHF) | Identical or similar | | | | | | | | | | | | | | | Table 1. Comparison between the subject device and the predicate device {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | | On extremities that are insensitive to pain. Where increased venous or lymphatic return is undesirable. | peripheral arterial disease; • Acute infections of the skin such as cellulitis; • Any lower limb malignancy. | On extremities that are insensitive to pain. Where increased venous or lymphatic return is undesirable. | | | Identical | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Target Population / Intended Users | Patients who need venous return and lymphedema treatment | Patients who need venous return and lymphedema treatment | Patients who need venous return | Patients who need venous return and lymphedema treatment | Patients who need venous return and lymphedema treatment | 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 | 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 | Non-invasive / external | Non-invasive / external | Identical | | Portability | Portable, ambulant | Portable, ambulant | 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 extremities | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities | Identical | | Anatomical Site / Location of treatment application | Leg | Leg | Lower limb(s) (Calf) | Leg, Arm | Leg, Arm, Vest | Identical | | System management | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Identical | | Pressure Source | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Identical | | Operating Modes | Preset and adjustable modes | Two preset modes | Two preset modes | Adjustable modes | Preset and adjustable modes | Identical | | Working Pressure | Preset at 50 mmHg and adjustable from 20 - 80 mmHg | Preset at 20 - 50 mmHg | Preset at approximately 55 mmHg | Adjustable at 20 - 80 mmHg | Preset at 60 mmHg and adjustable from 30 – 120 mmHg | Identical or similar | | Cycle Time | In the preset 50mmHg mode, each chamber will inflate in sequence, starting at the foot and working up toward the knee until all of the chambers reach the intended pressure levels. All four chambers will then deflate to the low pressure level. This cycle of inflation and deflation will continue until the device is turn off. In the adjustable 20 | When it is first switched on in the Sustained Compression Mode, the device gradually inflates, starting at the foot and working up toward the knee. Each chamber will stop inflating when the correct pressures are achieved and will hold these pressures until the device is turned off. When in Intermittent | 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 seconds / leg. Each cycle consists of inflation of a bladder, followed by a rest period during which the | Stays on in a pulsing manner and then release until the user turns it off or can be set up to turn off in a range of 10 to 180 minutes | In the preset 60mmHg mode, each chamber will inflate in sequence, startin…

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