Movement and Compressions System (the MAC System)

K203052 · Recovery Force, LLC · JOW · Mar 21, 2021 · Cardiovascular

Device Facts

• Record ID: K203052
• Device Name: Movement and Compressions System (the MAC System)
• Applicant: Recovery Force, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs: - Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and, - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium. The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

Device Story

Portable, rechargeable, intermittent compression device; stimulates lower limb blood flow via mechanical strap contraction. Components: disposable calf strap, controller (battery, DC motor, 6-axis gyroscope, microprocessor), charging hub. Used in home/clinical settings by adults; prescribed by healthcare professionals. Controller applies mechanical force to calf muscle; no pneumatic pumps/air supply. System monitors patient orientation/movement via gyroscope; stores data in RFID tag in strap. Data synced between controller and strap via RFID. Healthcare providers use displayed activity/orientation data to benchmark patient mobility, implement management plans, and identify immobility-related risks (DVT, pressure ulcers, pneumonia, delirium). Benefits: non-pneumatic compression reduces contamination risk; mobility monitoring aids individualized care.

Clinical Evidence

Bench testing only. Evaluated blood flow increase over baseline, strap elasticity, shear strength, battery safety, electrical/EMC compliance (IEC 60601-1, 60601-1-2, 60601-1-11), and usability. Accuracy of mobility data and strap slippage verified.

Technological Characteristics

Intermittent compression via DC motor-driven strap. 6-axis gyroscope for orientation/movement. RFID for data sync. Powered by 3.6V Li-Ion battery. Non-sterile. Biocompatible materials per ISO 10993-1. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), IEC 60601-1-6 (usability).

Indications for Use

Indicated for adult patients to aid in DVT prevention by enhancing blood circulation and as DVT prophylaxis for individuals expecting to be stationary for long periods. Also indicated for monitoring patient orientation and movement to assist in managing immobility-related risk factors.

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

• ActiveCare DVT System (K140755)

Reference Devices

• Recovery Force RF1400 Active Compression Wrap (K162481)
• DynaSense System (K130752)

Submission Summary (Full Text)

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March 21, 2021

Recovery Force, LLC % Deborah Grayeski Sr. Project Manager M Squared Associates 127 West 30th Street. 9th Floor New York, New York 10001

Re: K203052

Trade/Device Name: Movement and Compressions System (the MAC System) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 16, 2021 Received: February 17, 2021

Dear Deborah Grayeski:

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.

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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 (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 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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K203052

#### Device Name

Movement and Compressions System (The MACTM System)

#### Indications for Use (Describe)

The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:

- · Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
- · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.

During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.

The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

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

| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------|

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### 510(K) SUMMARY

| SUBMITTER: | Recovery Force LLC |
|------------|------------------------------|
| | 10022 Lantern Rd., Suite 100 |
| | Fishers, IN 46037 |

CONTACT: Deborah Lavoie Grayeski M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York NY 10001 Ph. 347-307-6951/202-550-7395 Fax. [phone] Email. [e-mail]

#### DATE PREPARED:

### DEVICE:

| Proprietary Name: | Movement and Compressions System (The MAC™ System) |
|----------------------|----------------------------------------------------|
| Common Name: | Compressible Limb Sleeve |
| Classification Name: | Compressible Limb Sleeve, 21 CFR 870.5800 |
| Regulatory Class: | Class II |
| Product Code: | JOW |

March 17, 2021

### PREDICATE AND REFERENCE DEVICE:

| Primary Predicate: Medical Compression Systems (DBN) Ltd's ActiveCare DVT | |
|---------------------------------------------------------------------------|--|
| System. K140755 | |
| | |

- Reference Devices: Recovery Force RF1400 Active Compression Wrap, K162481 Centauri Medical, Inc., DynaSense System, K130752
Neither the predicate nor reference devices has been subject to a recall.

### DEVICE DESCRIPTION:

The Movement and Compressions System (The MACTM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single

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patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.

Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients.

The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.

## INDICATIONS FOR USE:

The Movement and Compressions System is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs:

- Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood . circulation: and,
- As a prophylaxis for DVT by persons expecting to be stationary for long periods . of time.

During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.

The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

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### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

A comparison of the technological characteristics between The MAC System to the predicate and reference devices is presented in Table 1.

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| Table 1. Comparison of the technological characteristics between The MAC System to the predicate and reference devices. | | | | |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Recovery Force | Medical Compression Systems | Recovery Force | Centauri Medical, Inc. |
| Device | The MAC System<br>(Subject Device) | ActiveCare DVT System<br>(Primary Predicate) | Recovery Force RF1400 Active<br>Compression Wrap<br>(Reference Device) | DynaSense System<br>(Reference Device) |
| 510(k) Number | TBD | K140755 | K162481 | K130752 |
| Classification<br>Regulation<br>Product Code | Class II, (21 CFR 870.5800)<br>Compressible Limb Sleeve<br>JOW | Class II, (21 CFR 870.5800)<br>Compressible Limb Sleeve<br>JOW | Class II, (21 CFR 870.5800)<br>Compressible Limb Sleeve<br>JOW | Class I, (21 CFR 880.2400)<br>Bed-patient monitor<br>KMI |
| | Subsequent code: KMI | | | |
| Device<br>Description | The Movement and Compressions<br>System (The MAC™ System) is a<br>prescriptive, portable, rechargeable-<br>battery powered, intermittent<br>compression device designed to<br>stimulate blood flow in the lower<br>limb. The MAC System consists of<br>the MAC Strap, MAC Charging<br>Hub, and MAC Controller. The<br>MAC Strap is a disposable single-<br>patient use strap that is wrapped<br>around the patient's calf muscle.<br>The MAC Controller houses a<br>rechargeable battery, a small DC<br>motor, a 6-axis gyroscope sensor,<br>and microprocessor that is attached<br>to the strap during use. The battery<br>is removed from the controller for<br>charging in the supplied MAC<br>Charging Hub when not in use.<br>Compression is applied to the calf,<br>immediately below the knee, by<br>intermittent application of<br>mechanical force by the device<br>strap. When the strap is contracted,<br>compression is applied to the | The ActiveCare+DTx,<br>ActiveCare+SFT and ActiveCare DVT<br>Systems are prescriptive, pneumatic<br>compression Systems designed to<br>apply sequential compression to the<br>lower limb. The control units of the<br>Systems provide the user with several<br>treatment options: compression of the<br>foot - single or double, compression of<br>the calf - single or double,<br>compression of the thigh - single or<br>double, and combined compression of<br>any combination of two sleeves. The<br>foot compression program is an<br>intermittent pressure pulse application<br>to a single celled foot sleeve. The calf<br>and thigh compression program is a<br>sequential intermittent application of a<br>pressure to a three-celled cuff sleeve. | The RF1400 Active Compression<br>Wrap is a lightweight, portable,<br>rechargeable battery powered,<br>prescriptive device that helps<br>stimulate blood flow in the lower limb<br>through the use of intermittent<br>sequential compression. The wrap<br>contains nickel titanium, martensite to<br>austenite phase change wires, using a<br>battery-powered microprocessor to<br>"excite" and "relax" the wires<br>resulting in compression. The battery<br>and microprocessor components are<br>protectively housed in a plastic<br>controller case that is permanently<br>attached to the wrap. A single, touch<br>control button interface and a RGB<br>LED light indicator provide the user<br>interface, and there is a port for<br>connecting the battery charger plug.<br>The wrap is available in a wide range<br>of sizes XS, S, M, and L, to<br>accommodate varying anatomy sizes.<br>The wrap is divided into three discrete<br>zones which are externally applied to<br>the limb. After one zone is fully | DynaSense is a patient monitoring<br>system that has been designed for<br>use in hospitals, nursing homes, or<br>other patient care facilities to aid<br>standard care procedures for<br>patients who are susceptible to<br>pressure ulcers. The system<br>monitors and reports patient<br>activity and orientation as well as<br>alerts the user (i.e., healthcare<br>provider) when activity levels<br>deviate from parameters set by<br>healthcare providers. DynaSense is<br>comprised of Patient Sensors, Relay<br>Antennas, a USB RE Transceiver,<br>Mesh Network Server Software,<br>and User Interface software. Each<br>Patient Sensor is associated with a<br>single patient, such that the patient's<br>orientation and activity can be<br>monitored. Data collected by the<br>Patient Sensor is automatically<br>communicated wirelessly to a<br>nearby Relay Antenna, which<br>subsequently relays these data to be<br>displayed on the User Interface and<br>maintained in a database. The |

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| patient's calf muscle. When the | activated for a period of time and turns | system's Relay Antennas that are |
|---------------------------------------|------------------------------------------|--------------------------------------|
| strap is retracted, compression force | off, then the next zone is activated. | plugged into electrical outlets on |
| is released from the patient's calf | This cycle continues until all three | the walls of the facility and the |
| muscle. | zones have activated and turned off. | USB RIF Transceiver that is |
| | Then the sequence is repeated after a | plugged into the computer, on |
| Since mechanical force is used to | short delay. This cycle repeats until | which the Mesh Network Server |
| provide intermittent compression, | the unit is turned off. The wrap may | Software is installed or accessed, |
| the system does not require a | be used on one or both legs. When | form a wireless network that allows |
| powered air supply, so the risk of | used on both legs, the wraps operate | data to be transmitted for display. |
| aerosolization of potential | separately. The wrap is supplied with | The Mesh Network Server |
| contaminants or germs is mitigated | a rechargeable battery, which can be | Software manages this network of |
| as there is no blowing air. There | charged when not in use. | Relay Antennas and USB REF |
| are no air connections or pneumatic | | Transceiver and collects the data |
| pumps to clean between patients. | | from the Patient Sensors to allow |
| | | monitoring of multiple patients on a |
| The strap is available in two sizes: | | single screen within the User |
| Standard and XL. The system may | | Interface. |
| be used on one or both legs. When | | |
| used on both legs, the wraps operate | | |
| separately. | | |
| | | |
| The MAC System also monitors | | |
| and displays patient orientation and | | |
| movement information (see | | |
| DynaSense reference device, | | |
| K130752). This data is stored in a | | |
| RFID tag in the MAC Strap. When | | |
| the MAC Controller is connected to | | |
| the MAC Strap, and functioning, all | | |
| DVT prophylaxis compliance data, | | |
| orientation and movement data is | | |
| synced between the strap and | | |
| controller using Radio Frequency | | |
| Identification (RFID) | | |
| communication and stored between | | |
| them. | | |
| | | |

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| Intended Use | Lower limb compression | Lower limb compression | Lower limb compression | Monitor orientation and activity. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Movement and Compressions<br>System is intended to be a portable<br>and wearable system, prescribed by<br>healthcare professionals, to treat the<br>following conditions by stimulating<br>blood flow in the legs:<br>• Aid in the prevention of DVT<br>(deep vein thrombosis) by<br>enhancing blood circulation;<br>and,<br>• As a prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods of<br>time.<br><br>During use, the system also<br>monitors patient orientation and<br>movement. It allows healthcare<br>providers and users to implement<br>individualized patient management<br>plans for DVT prophylaxis and<br>patient mobility protocols by<br>utilizing data accumulated by the<br>patient on the previous day as a<br>benchmark. The data displayed on<br>the device allows providers to<br>monitor the patient's orientation<br>and activity, which can be used to<br>identify risk factors for hospital-<br>acquired events linked to<br>immobility such as: deep vein<br>thrombosis, pressure ulcers,<br>pneumonia, atrophic muscles, and<br>delirium. | The ActiveCare DVT, ActiveCare+SFT<br>and ActiveCare+DTx Systems are<br>prescriptive devices that induce<br>Continuous Enhanced Circulation<br>Therapy of the lower limbs. The<br>Systems are intended for use in:<br>• Preventing Deep Vein Thrombosis<br>(DVT).<br>• Enhancing blood circulation.<br>• Diminishing post-operative pain and<br>swelling.<br>• Reducing wound-healing time.<br>• Treatment and assistance in healing:<br>stasis dermatitis; venous stasis<br>ulcers; arterial and diabetic leg<br>ulcers.<br>• Treatment of chronic venous<br>insufficiency.<br>• Reducing edema. | Intended to be a portable and wearable<br>system, prescribed by healthcare<br>professionals, to treat the following<br>conditions by stimulating blood flow<br>in the lower limbs:<br>• Aid in the prevention of DVT;<br>• Enhance blood circulation;<br>• Diminish post-operative pain and<br>swelling;<br>• Reduce wound healing time;<br>• Aid in the treatment and healing of:<br>stasis dermatitis, venous stasis<br>ulcers, arterial and diabetic leg<br>ulcers, chronic venous<br>insufficiency, chronic lymphedema,<br>and reduction of edema in the lower<br>limbs;<br>• As a prophylaxis for DVT by<br>persons expecting to be stationary<br>for long periods of time.<br>• Reduction of edema associated with<br>soft tissue injuries, such as burns,<br>postoperative or post-<br>immobilization edema, or ligament<br>sprains.<br><br>The device can be used in the home or<br>clinical setting. The device is<br>intended for use in an adult patient<br>population. | DynaSense monitors orientation<br>and activity of patients susceptible<br>to pressure ulcers. It allows<br>healthcare providers to implement<br>individualized turn management<br>plans and continuously monitor<br>each patient. DynaSense provides<br>alerts when patient orientation or<br>activity deviates from parameters<br>set by healthcare providers. The<br>device is intended for use in<br>medical, nursing and long-term care<br>facilities including independent<br>living, assisted living and<br>rehabilitation facilities. |
| Target<br>Population/<br>Where used | The device can be used in the home<br>or clinical setting. The device is<br>intended for use in an adult patient<br>population. | Home or clinical setting. | Home or clinical setting. | Medical, nursing and long-term<br>care facilities including<br>independent living, assisted living |
| | Home or clinical setting. | Home or clinical setting. | Home or clinical setting. | |
| Anatomical Site | Lower leg | Lower leg | Lower leg | Sensor attaches to patient's<br>sternum. |
| Principle of<br>Operation | Intermittent compression via DC<br>motor strap tightening.<br>Patient orientation and movement<br>monitored using a 6-axis gyroscope<br>sensor/step counter. | Sequential, intermittent, pneumatic<br>compression | Nickel titanium, martensite to<br>austenite phase change wires, resulting<br>in compression. | Patient orientation and activity<br>monitored using a patient sensor. |
| Weight | 11 oz | 1.65 lb | 1.00 lb | Unknown |
| Dimension | 6 H (at largest part) x 22.25 L<br>(Standard size), 0.3 thick<br>(Excluding Controller) inches. | 5.3 x 5.3 x 2.4 inches | 9 H x 20 L (Small size), 0.3 thick<br>(excluding controller) inches | Sensor 1.8" x 2.0" |
| Cycle Time | 60 seconds consisting of the<br>following sequence:<br>• Compression for ≤1 second<br>• Hold for 1 second<br>• Compression release for ≤ 2<br>seconds<br>• No compressions for ~ 56<br>seconds | 30 seconds consisting of the<br>following sequence:<br>• Bottom Zone inflation for 2-3<br>seconds<br>• Middle Zone inflation for 2-3<br>seconds<br>• Top Zone inflation for 2-3<br>seconds<br>Cuff deflates to a total cycle time of 30<br>seconds, then cycle restarts. | 30 seconds consisting of the<br>following sequence:<br>• Bottom Zone compression for<br>2 seconds<br>• Middle Zone compression for<br>2 seconds<br>• Top Zone compression for 2<br>seconds<br>• No compressions for 24<br>seconds | N/A, this device is solely<br>referenced for its use in<br>monitoring patient orientation<br>and activity. |
| Biocompatibility | Biocompatible | Biocompatible…