Who is the manufacturer of PlasmaFlight?

Manamed, Inc. filed the 510(k) submission for PlasmaFlight (K200351).

What is the FDA product code for PlasmaFlight?

IRP. It is classified under 21 CFR 890.5650 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for PlasmaFlight?

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

What are the predicate devices for PlasmaFlight?

PowerPlay Muscle Massager, PPRT-01 (K122154).

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

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.

PlasmaFlight

K200351 · Manamed, Inc. · IRP · Aug 5, 2020 · Physical Medicine

Device Facts

Record ID	K200351
Device Name	PlasmaFlight
Applicant	Manamed, Inc.
Product Code	IRP · Physical Medicine
Decision Date	Aug 5, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5650
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

PlasmaFlight is a portable, rechargeable, over-the-counter inflatable tube massage system. It consists of an electronically controlled air pump unit and an inflatable pressure cuff. The device simulates manual kneading and stroking of tissue via cyclic, intermittent pneumatic pressure. The user operates the device via an ON/OFF button; the system automatically inflates the cuff to a default pressure (55 mmHg), holds, and then deflates through an internal valve. This cycle repeats until the user turns the device off. It is intended for home or mobile use (e.g., altitude travel). The device provides temporary relief of minor muscle aches and pains and increases blood circulation. It includes audible and visual alarms for system faults, low pressure, and low battery. The device is non-sterile and intended for single-patient use.

Clinical Evidence

Bench testing only. The device underwent verification and validation testing, including electrical safety (ANSI AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2). Performance testing confirmed the device meets physical, electrical, and software requirements. No clinical data was provided.

Technological Characteristics

Portable, battery-operated (3.7V rechargeable) or AC-powered (5V DC) pneumatic massager. Features a microprocessor-controlled micro-pump, pressure switch, and inflatable cuff (air bladder encased in non-latex medical fabric). Dimensions: 116x65x19mm; Weight: 0.23kg. Operates at a preset 55 mmHg. Software is classified as moderate level of concern. Biocompatible materials used for patient contact. Clean, non-sterile.

Indications for Use

Indicated for individuals seeking temporary increase in blood circulation and relief of minor muscle aches and pains. Contraindicated for persons with suspected, active, or untreated deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, or active infection. Not for use on legs where cuffs interfere with vein ligation, gangrene, dermatitis, open wounds, recent skin grafts, massive edema, or extreme deformity; on neuropathy; on extremities insensitive to pain; or where increased venous/lymphatic return is undesirable.

Regulatory Classification

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.

Predicate Devices

PowerPlay Muscle Massager, PPRT-01 (K122154)

Reference Devices

PlasmaFlow (K160318)

Related Devices

K201694 — Air Compression Therapy Device · Shenzhen Dongjilian Electronics Co., Ltd. · Nov 19, 2020
K223464 — Leg and Foot Air Wave Pressure Therapy Device · Zhangzhou Easepal Innovation CO , Ltd. · Mar 14, 2023
K032505 — AIR PRESS MASSAGER · Telebrands Corp · Sep 24, 2003
K122154 — POWERPLAY MUSCLE MASSAGER · Fig, LLC · Nov 21, 2012
K212935 — Air Pressure Foot Massager · Xiamen Simo Electronic Co., Ltd. · Feb 19, 2022

Submission Summary (Full Text)

{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) | 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: 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…

PlasmaFlight

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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PlasmaFlight

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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