Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

K181149 · Zenith Technical Innovations · IRP · Aug 3, 2018 · Physical Medicine

Device Facts

• Record ID: K181149
• Device Name: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
• Applicant: Zenith Technical Innovations
• Product Code: IRP · Physical Medicine
• Decision Date: Aug 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression. Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Device Story

Therm-X is an AC-powered, software-controlled multimodality system for clinical or home use. It delivers iceless cold, heat, contrast (alternating), and pneumatic compression therapy via single-patient use inflatable garments (back, elbow, shoulder, ankle, knee). Pro/Athlete models include DVT prophylaxis (foot/calf). The device features a centralized coolant reservoir, pumps, fans, and a touch-screen interface for monitoring/adjusting therapy parameters (time, temperature, compression). Healthcare providers can set password-protected cycles to ensure patient compliance. The device uses thermoelectric cooling/heating. It is operated by healthcare professionals or patients under prescription. Output is localized thermal and compression therapy, which aids blood flow and reduces edema/pain, benefiting post-surgical and injured patients.

Clinical Evidence

Bench testing verified performance specifications, electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Skin temperature testing confirmed that temperature limits do not cause thermal damage. Human factors/usability assessments in simulated environments confirmed safe and effective operation by intended users.

Technological Characteristics

AC-powered, software-controlled multimodality device. Thermoelectric heating/cooling. Touch-screen interface. Dimensions: 15" L x 10.5" W x 9" H. Weight: 15 lbs (full). Materials: 30/200 denier nylon garments. Electrical safety: ANSI/AAMI ES60601-1, IEC 60601-1-2. Non-sterile. Connectivity: Standalone.

Indications for Use

Indicated for patients requiring cold, heat, contrast, or compression therapy for post-surgical/acute injury edema, swelling, and pain reduction. Also indicated for post-traumatic/post-surgical conditions requiring localized thermal therapy. Therm-X Pro and Pro Athlete models are indicated for DVT prophylaxis via lower extremity compression.

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

• Med4 Elite™ (K171685)
• VascuTherm™ (K061866)
• GameReady® Classic System (GR 2) (K072620)
• IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (K131327)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized human figure. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.

August 3, 2018

Zenith Technical Innovations % Rita King CEO MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560

Re: K181149

Trade/Device Name: Therm-X Pro, Therm-X Pro Athlete, Therm-X AT Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. ILO. JOW Dated: June 7, 2018 Received: June 7, 2018

Dear Rita King:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael J. Hoffmann -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181149

Device Name Therm-X Pro, Therm-X Pro Athlete, Therm-X AT

#### Indications for Use (Describe)

Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intent post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow beart via lower extremity limb compression.

Therm-X (Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilities, outpatient clinics, athletic training settings, and home settings.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|--|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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## 510(k) Summary

#### Zenith Technical Innovations K181149

This 510(k) Summary is in conformance with 21 CFR 807.92

| Submitter: | Zenith Technical Innovations, LLC. (Zenith)<br>1396 St. Paul Ave.<br>Gurnee, IL 60031<br>Phone: [phone]<br>Fax: [phone] |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Greg Binversie<br>Chief Technology Officer |
| Date Prepared: | June 7, 2018 |

#### Device Name and Classification

| Trade Name: | Therm-X |
|-----------------------|--------------------------------------------------|
| Common Name: | Heat and/or Cold and Compression Therapy |
| Classification: | Class II |
| Regulation Number: | 21 CFR 890.5650, Powered inflatable tube massage |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |

## Predicate Devices

| Predicate: | Primary | Secondary | Secondary | Reference |
|----------------------------------|---------------------------------------------------|-----------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------|
| Trade Name: | Med4 Elite™ | VascuTherm™<br>(and<br>NanoTherm™) | GameReady®<br>Classic System<br>(GR 2) | IC-BAP-DL<br>BioArterial<br>Plus Aterial<br>Blood Flow<br>Enhancement<br>System |
| Common<br>Name: | Heat and/or<br>Cold and<br>Compression<br>Therapy | Intermittent,<br>External<br>Pneumatic<br>Compression<br>Device | Cold/compression<br>therapy system | BAP-DL<br>BioArterial<br>Plus Arterial<br>Blood Flow<br>Intermittent<br>Circulator |
| 510(k)<br>Submitter /<br>Holder: | CoolSystems,<br>Inc. | ThermoTek,<br>Inc. | CoolSystems,<br>Inc. | Bio<br>Compression<br>Systems, Inc |

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| 510(k)<br>Number: | K171685 | K061866 | K072620 | K131327 |
|--------------------------|--------------------------------------------------------|------------------------------------------|-----------------------------------------------------|------------------------------------------|
| Classification: | Class II | Class II | Class II | Class II |
| Regulation<br>Number: | 890.5650,<br>Powered<br>Inflatable<br>tube<br>massager | 870.5800,<br>Compressible<br>limb sleeve | 890.5650,<br>Powered<br>inflatable tube<br>massager | 870.5800,<br>Compressible<br>limb sleeve |
| Classification<br>Panel: | Physical<br>Medicine | Cardiovascular | Physical Medicine | Cardiovascular |
| Product<br>Code: | IRP, ILO | JOW, ILO | IRP, ILO | JOW |

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#### Device Description

Therm-X is an AC powered, software-controlled multimodality device, designed to be used in a clinical or home-use setting, and under the direction, prescription of a licensed healthcare professional. The device is available in three configurations: Therm-X Pro, Therm-X Pro Athlete and Therm-X AT.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT prophylaxis therapy.

Therm-X consists of various single-patient use inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, or knee and DVT prophylactic treatment applied to the foot or calf. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with pneumatic compression. The Foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by Therm-X Pro and Therm-X Pro Athlete systems only.

Therm-X is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. Therm-X AT and Therm-X Pro models provide an optional password protection feature that allows for a home user to use a stored cvcle without being able to change it, giving health care providers an ability to ensure compliance to a chosen cycle. The device also provides functionality to allow the health care provider to assign a date at which the user will be able to access a second stored cycle instead of the first.

The Therm-X is approximately 15 lbs. when filled with coolant and has a handle placed on the top of the device. It has a centralized coolant reservoir accessible through a cap located at the back of the device that supplies its coolant and radiator systems. The reservoir, pumps, fans, circuit board, and other components of the Therm-X are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

#### Indications for Use

Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

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#### Risk Analysis Method

The Therm-X was assessed to determine the risks to health associated with the use of the device and evaluated risks related to safety, effectiveness and usability. A risk analysis was conducted in accordance with ISO 14971:2007 and ISO14971:2012, Medical devices --Application of risk management to medical devices. Several risks were assessed, including, but not limited to, device malfunction, allergic reaction, infection and improper use.

#### Substantial Equivalence

Therm-X is substantially equivalent to Med4 Elite by Coolsystems, Inc. (K171685), VascuTherm by ThermoTek, Inc. (K061866), GameReady® Classic System (GR 2) by Coolsystems, Inc. (K072620), and IC-BAP-DL BioArterial Plus Aterial Blood Flow Enhancement System by Bio Compression Systems, Inc, (K131327) currently on the market.

Therm-X has the same intended use and indications for use as the predicate devices and uses equivalent overall design and operating principals as the predicate devices.

The table below provides a detailed comparison of Therm-X to the predicate devices.

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| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™) (K061866)<br>Secondary Predicate | Game Ready® Classic System<br>(GR 2) (K072620)<br>Secondary Predicate | Comparisons and Reference Device |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Therm-X (Therm-X Pro, Therm-X Pro<br>Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.<br><br>Therm-X Pro and Therm-X Pro Athlete | The Med4 Elite™ combines cold, heat, contrast and compression therapies.<br><br>It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated.<br><br>It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated.<br><br>It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings. | Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.<br><br>Reduction of edema associated with soft tissue injuries such as bums, postoperative edema, and ligament sprains | It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The indications for use of the Therm-X are identical to the Med4 Elite™ with the only difference being that the Therm-X also provides DVT therapy and is being used in both professional and home settings.<br><br>The indications for use of Therm-X (Therm-X Pro and Therm-X Pro Athlete) are also identical to VascuTherm™ |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| | systems also provide<br>DVT therapy. Therm-<br>X Pro and Therm-X<br>Pro Athlete are<br>intended to reduce<br>the risk of the<br>formation of deep<br>venous thrombosis<br>(DVT) by aiding<br>blood flow back to<br>the heart via lower<br>extremity limb<br>compression. | | Localized thermal<br>therapy (hot or<br>cold) for post<br>traumatic and<br>post surgical<br>medical and/or<br>surgical<br>conditions. | | for DVT<br>therapy and for<br>use in home<br>settings. |
| | Therm-X (Therm-X<br>Pro, Therm-X Pro<br>Athlete and Therm-X<br>AT) is intended to be<br>used by, or on the<br>order of, licensed<br>healthcare<br>professionals in<br>rehabilitation<br>facilities, outpatient<br>clinics, athletic<br>training settings, and<br>home settings. | | Decrease the risk<br>of deep venous<br>thrombosis<br>(DVT).<br><br>Aids the blood<br>flow back to the<br>heart.<br><br>Treat and assist<br>healing of<br>cutaneous<br>ulceration<br>(wounds), reduce<br>would healing<br>time, enhance<br>arterial circulation | | The indications<br>for use of the<br>Therm-X are<br>equivalent to<br>Game Ready®<br>for use in home<br>settings with<br>the only<br>difference<br>being that<br>Game Ready<br>does not<br>provide DVT<br>Therapy. |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| Intended Users | Healthcare<br>Professionals and<br>patients (i.e. General<br>Patient Users and<br>"Professional" Athlete<br>Users at home under<br>prescription) | Healthcare Professionals only<br>(Prescription use) | (blood flow),<br>reduce<br>compartmental<br>pressures,<br>reduce edema<br>(swelling), reduce<br>the need for<br>anticoagulant<br>(blood thinning)<br>medications.<br><br>Healthcare<br>Professionals<br>only and patients<br>(at home under<br>prescription) | Healthcare<br>Professionals and<br>patients (at home<br>under prescription) | Therm-X<br>intended users<br>are identical to<br>the intended<br>users of the<br>VascuTherm™<br>and Game<br>Ready® |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™ 4 and VascuTherm™ 5) and NanoTherm™)<br>(K061866)<br>Secondary Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary Predicate | Comparisons<br>and Reference<br>Device |
| | | | | | Therm-X intended users are equivalent to the Med4 Elite™ with the only difference being that the intended users for the Med4 Elite™ do not include patients in the home setting. |
| Number of<br>Patients that can<br>be treated at one<br>time | One | Two | One | One | Therm-X is designed to treat one patient at a time and it is identical to the VascuTherm™ and the Game Ready®. |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| Two<br>Programmable<br>Cycles | Configuration of two<br>programmable cycles<br>are available for all<br>Therm-X Models | Configuration of two<br>programmable cycles (one<br>cycle per patient) | Configuration of<br>three<br>programmable<br>cycles (therapy<br>profiles) | Not Available | The Therm-<br>X is equivalent<br>to the Med4<br>Elite™ and<br>VascuTherm™. |
| | | Functions | | | |
| Heat Therapy<br>Temperatures | Default: 105, 107,<br>110°F<br>Custom: 105°F –<br>110°F | 95 – 113°F (35 – 45°C) | 105°F | Not available | The Therm-X<br>Heat Therapy<br>Temperature<br>Range is<br>equivalent to<br>the Med4<br>Elite™. |
| Cold Therapy<br>Temperatures | Default: 34, 45, 55°F<br>Custom: 34 – 55°F | 38 – 60°F (3.33 – 15.56°C) | 43 – 49°F | 34 – 50°F | The Therm-X<br>temperature<br>range for Cold<br>Therapy is<br>equivalent to<br>the Med4<br>Elite™ and<br>Game Ready®.<br>The Therm-X<br>minimum<br>temperature<br>range for Cold<br>Therapy is |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| | | | | | identical to<br>Game Ready®.<br>The Therm-X<br>maximum<br>temperature<br>range for Cold<br>Therapy is<br>equivalent to<br>Med4 Elite™ |
| Edema<br>Compression<br>combined with<br>heat, cold or<br>contrast therapy | Available | Available with or without heat<br>therapy, cold therapy or<br>contrast therapy. | Available with or<br>without heat<br>therapy, cold<br>therapy or<br>contrast therapy<br>(contrast therapy<br>is available only<br>in VascuTherm™<br>5). | Available with cold<br>therapy. | Therm-X is<br>identical to<br>Game Ready®<br>for combining<br>edema<br>compression<br>with cold<br>therapy. The<br>Therm-X is<br>equivalent to<br>the Med4<br>Elite™ and<br>VascuTherm™<br>with the<br>difference that<br>Med4 Elite™<br>and<br>VascuTherm™ |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| | | | | | also provide<br>compression<br>without heat,<br>cold or contrast<br>therapy. |
| Edema<br>Compression<br>Levels | Available in three<br>levels<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Available in four levels<br>Low (5 – 15 mm Hg)<br>Medium - Low (5 - 30 mm Hg)<br>Medium (5 - 50 mm Hg)<br>High (5 - 75 mm Hg) | Available in three<br>levels (general)<br>Low (15 mm Hg)<br>Medium (30 mm<br>Hg)<br>High (50 mm Hg) | Available in three<br>levels<br>Low (5 - 15 mm Hg)<br>Medium (5 - 50 mm<br>Hg)<br>High (5 – 75 mm<br>Hg) | The edema<br>compression<br>levels for<br>Therm-X are<br>equivalent to<br>the<br>compression<br>levels for the<br>Med4 Elite™<br>and Game<br>Ready.<br>Therm-X like<br>VascuTherm™<br>provides<br>constant values<br>for Low,<br>Medium and<br>High<br>compression. |
| DVT Only | Available for Therm-<br>X Pro Athlete and<br>Therm-X Pro Models | Not Available | Available | Not Available | Therm-X Pro<br>Athlete and<br>Therm-X Pro |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| | | | | | Models are<br>identical to<br>VascuTherm™. |
| DVT<br>Compression | Calf: 50 - 70 mm Hg<br>Foot: 100 – 130 mm<br>Hg | Not available | Calf: 45 mm Hg<br>Foot: 100 mm Hg | Not available | Therm-X<br>(Therm-X Pro<br>and Therm-X<br>Pro Athlete<br>Models) has a<br>higher range<br>for Foot and<br>Calf DVT<br>compression<br>than the<br>VascuTherm™<br>and has<br>equivalent DVT<br>compression to<br>reference<br>predicate, IC-<br>BAP-DL<br>BioArterial Plus<br>Arterial Blood<br>Flow<br>Enhancement<br>System<br>(K131327) |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™<br>4 and<br>VascuTherm™<br>5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate | Comparisons<br>and Reference<br>Device |
| Cycle Length (for<br>Heat, Cold and<br>Compression) | Heat: 20, 30, or 40<br>minutes<br>Cold: 20, 30, or 40<br>minutes<br>Compression: 20, 30,<br>or 40 minutes | Heat: 5 to 30 minutes, 15<br>minutes default<br>Cold: 5 to 60 minutes, 15<br>minutes default<br>Compression Only: 5 to 60<br>minutes, 15 minutes default | Heat: 30 minutes<br>(presumed - not<br>clearly stated in<br>User Manual)<br>Cold: 30 minutes<br>(presumed not<br>clearly stated in<br>User Manual)<br>Compression:<br>Unknown | Heat: Not available<br>Cold: 5 to 90<br>minutes, 15 minutes<br>default<br>Compression: Not<br>available | The Therm-X<br>Cycle length for<br>Heat, Cold and<br>Compression is<br>equivalent to<br>Med4 Elite™ |
| Contrast Therapy<br>(for Heat, Cold<br>and<br>Compression) | Available<br>Heat: 10 minutes<br>Cold: 10 minutes<br>Total treatment: 5<br>cycles of alternating<br>heat and cold<br>treatment for total<br>duration of 100<br>minutes | Available<br>Heat: 1 - 10 minutes, default 3<br>minutes<br>Cold: 1 - 10 minutes, default 3<br>minutes<br>Total treatment: 15 - 90<br>minutes, default 30 minutes | Available<br>Heat: 10 minutes<br>Cold: 20 minutes<br>Contrast therapy<br>is available only<br>in VascuTherm™<br>5 | Not available | Therm-X<br>Contrast<br>therapy<br>function is<br>equivalent to<br>the Med4<br>Elite ™. |
| DVT Cycle<br>Length | No specified time<br>interval. DVT can be<br>stopped at any time<br>by the user. | Not available | 30 minutes<br>(presumed not<br>clearly stated in<br>User Manual) | Not available | Both the<br>Therm-X<br>(Therm-X Pro<br>and Therm-X<br>Pro Athlete<br>Models) and<br>VascuTherm™<br>provide DVT. |
| Characteristic | Therm-X<br>(this submission) | Med4 Elite™<br>(K171685) Primary predicate | VascuTherm™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Game Ready®<br>Classic System<br>(GR 2) (K072620)<br>Secondary<br>Predicate…