Therm-X (Home); Therm-X (AT)

K240125 · Zenith Technical Innovations · JOW · Jun 21, 2024 · Cardiovascular

Device Facts

• Record ID: K240125
• Device Name: Therm-X (Home); Therm-X (AT)
• Applicant: Zenith Technical Innovations
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 21, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) 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. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI). Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy 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 Home 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 device providing iceless cold, heat, contrast, and pneumatic compression therapy. It uses a centralized coolant reservoir, pumps, and fans to circulate fluid through flexible, reusable or single-patient inflatable wraps applied to various body parts (back, limbs, joints). Therm-X Home model includes DVT prophylaxis for foot/calf. Operated via touch screen interface by clinicians or patients (under prescription) in clinics or homes. Features include password-protected therapy cycles, adjustable pressure/temperature settings, and continuous therapy modes. Healthcare providers use the interface to monitor and assign specific treatment cycles to ensure patient compliance. By applying localized thermal therapy and compression, the device aims to reduce edema, swelling, and pain, and prevent DVT by promoting venous return. Benefits include non-pharmacological management of post-surgical/acute conditions and vascular disorders.

Clinical Evidence

Bench testing only. Performance verified against predetermined specifications. Biocompatibility tested per ISO 10993-5 and 10993-10. Electrical safety/EMC tested per IEC 60601-1, 60601-1-2, and 60601-1-11. Human factors/usability assessments performed in simulated environments. Clinical study on healthy volunteers confirmed minimum skin temperature of 40°F, demonstrating no thermal damage risk.

Technological Characteristics

AC-powered (100-240 VAC, 50/60 Hz). Thermoelectric heating/cooling mechanism. Inflatable wraps (nylon/urethane). Touch screen interface. Connectivity: Standalone. Software-controlled. Biocompatibility: ISO 10993-1, 5, 10. Electrical safety: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. Non-sterile. Multi-patient use garments validated for cleaning/disinfection.

Indications for Use

Indicated for patients requiring cold, heat, contrast, or compression therapy for post-surgical/acute injuries (edema, swelling, pain), post-traumatic/post-surgical conditions, and vascular/lymphatic insufficiency (lymphedema, CVI). Therm-X Home systems are also indicated for DVT prophylaxis in patients requiring lower extremity limb compression to aid blood flow. Intended for use by or on order of licensed healthcare professionals in clinics, rehab facilities, athletic training settings, or home.

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

• Therm-X (K231912)
• VascuTherm™ (K061866)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2024

Zenith Technical Innovations % Rita King Chief Executive Officer MethodSense, Inc. 1 Copley Parkway Suite 130 Morrisville, North Carolina 27560

Re: K240125

Trade/Device Name: Therm-X (Home); Therm-X (AT) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW, IRP, ILO Dated: May 23, 2024 Received: May 24, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Nicole M. Gillette -S

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

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Enclosure

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Reprocessed Single-Use Device Models Included in Clearance:

| Device<br>Model | Device Name | Original<br>Manufacturer |
|-----------------|--------------------------|--------------------------|
| TX0107 | Calf DVT Garment | ZTI |
| TX0106 | Foot DVT Garment | ZTI |
| TX0102 | Knee Thermal Garment | ZTI |
| TX0105 | Back Thermal Garment | ZTI |
| TX0101 | Shoulder Thermal Garment | ZTI |
| TX0110 | XL Shoulder Garment | ZTI |
| TX0104 | Ankle Thermal Garment | ZTI |
| TX0103 | Elbow Thermal Garment | ZTI |
| TX0108 | Hip Thermal Garment | ZTI |
| TX0111 | Half-leg Thermal Garment | ZTI |
| TX0112 | Hand Thermal Garment | ZTI |

DVT – Deep Vein Thrombosis

ZTI – Zenith Technical Innovations

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240125

Device Name

Therm-X (Therm-X Home and Therm-X AT)

Indications for Use (Describe)

Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) 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 surqical conditions for which localized thermal therapy (hot or cold) are indicated. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy 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 Home 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.

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

## Zenith Technical Innovations K240125

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] |
| Company Contact: | Greg Binversie<br>Chief Technical Officer |
| Date Prepared: | June 21, 2024 |

## Device Name and Classification

| Trade Name: | Therm-X |
|-----------------------|--------------------------------------------|
| Common Name: | Sleeve, Limb, Compressible |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.5800 - Compressible limb sleeve |
| Classification Panel: | Cardiovascular |
| Product Code: | JOW, IRP, ILO |

# Predicate Devices

| Trade Name: | Therm-X | VascuTherm™ |
|-------------------------------|------------------------------------------------|-----------------------------------------------------------|
| Common Name: | Heat and/or Cold and<br>Compression Therapy | Intermittent, External<br>Pneumatic Compression<br>Device |
| 510(k) Submitter /<br>Holder: | Zenith Technical Innovations,<br>LLC. (Zenith) | ThermoTek, Inc. |
| 510(k) Number: | K231912 | K061866 |
| Classification: | Class II | Class II |
| Regulation Number: | 890.5650, Powered Inflatable tube<br>massager | 870.5800 - Compressible<br>limb sleeve |
| Classification Panel: | Physical Medicine | Cardiovascular |
| Product Code: | IRP, ILO, JOW | JOW |

The predicate devices have not been subject to a design-related recall.

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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, or supervision of a licensed healthcare professional. The device is available in two configurations: Therm-X Home and Therm-X AT.

Therm-X (Therm-X Home and Therm-X AT) features iceless cold therapy, heat therapy, and contrast (alternating heat and cold) therapy. The Therm-X Home system also provides DVT prophylaxis therapy and continuous therapy for users who wish to receive treatment over an extended period of time.

Therm-X (Therm-X Home and Therm-X AT) consists of various reusable inflatable wraps for thermal treatment of the back, elbow, hand/wrist, shoulder, ankle, hip, lower leg, or knee and DVT prophylactic treatment applied to the foot or calf. Multi-patient use garments are available for all anatomical areas that can be cleaned and disinfected in between uses to be reused for different patients. Single-patient use garments are available for thermal treatment of the back, hand/wrist, shoulder, neck, ankle, hip, and knee and can be disposed of after patient treatment is concluded. The thermal garments are flexible coolant circulating garments that apply to the body to deliver cold, heat, or contrast therapy in combination with or without pneumatic compression. The foot and calf DVT prophylactic garments apply pneumatic compression alone and are intended for use by the Therm-X Home system only.

Therm-X (Therm-X Home and Therm-X AT) 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 Home models provide an optional password protection feature that allows for a user to use only stored cycles, 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 device also allows users to chanqe treatment pressure and temperatures to less extreme therapies (e.g. changing a warm cycle to a lower warm temperature or changing a cold cycle to a higher cold temperature).

Therm-X (Therm-X Home and Therm-X AT) 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 Home and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is

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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 (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).

Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy 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 Home 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.

## Risk Analysis Method

Therm-X (Therm-X Home and Therm-X AT) was assessed to determine the risks to health associated with the updated indications for use and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in accordance with ISO 14971:2019, Medical devices -- Application of risk management to medical devices. No additional risks were associated with the addition of treating disorders associated with vascular or lymphatic insufficiency such as lymphedema and chronic venous insufficiency (CVI) to the indications for use.

## Substantial Equivalence

Therm-X (Therm-X Home and Therm-X AT) is substantially equivalent to Therm-X (K231912) by Zenith Technical Innovations, LLC. (Zenith) and VascuTherm™ (K061866) by ThermoTek, Inc. currently on the market.

Therm-X (Therm-X Home and Therm-X AT) has the same intended use as the Therm-X (K231912) and VascuTherm™ (K061866) and uses equivalent overall design and operating principals as the Therm-X predicate device (K231912).

The table below provides a detailed comparison of Therm-X Home and Therm-X AT) to the predicate devices:

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# Detailed Comparison of the Subject and Predicate Devices

| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm ™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™) (K061866) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Indications for<br>Use | Therm-X (Therm-X Home and<br>Therm-X AT) combines cold,<br>heat, contrast, and<br>compression therapy. Therm-<br>X is intended to treat post-<br>surgical and acute injuries to<br>reduce edema, swelling, and<br>pain for which cold and<br>compression are indicated. It<br>is intended to treat post<br>traumatic and post-surgical<br>medical and/or surgical<br>conditions for which localized<br>thermal therapy (hot or cold)<br>are indicated.<br><br>Therm-X (Therm-X Home and<br>Therm-X AT) is also intended<br>for treatment of disorders<br>associated with vascular or<br>lymphatic insufficiency, such<br>as lymphedema and chronic<br>venous insufficiency (CVI).<br><br>Therm-X Home systems also<br>provide DVT therapy. Therm- | Therm-X (Therm-X Home and<br>Therm-X AT) combines cold,<br>heat, contrast, and<br>compression therapy. Therm-<br>X is intended to treat post-<br>surgical and acute injuries to<br>reduce edema, swelling, and<br>pain for which cold and<br>compression are indicated. It<br>is intended to treat post<br>traumatic and post-surgical<br>medical and/or surgical<br>conditions for which localized<br>thermal therapy (hot or cold)<br>are indicated.<br><br>Therm-X Home systems also<br>provide DVT therapy. Therm-<br>X Home systems with DVT<br>therapy are intended to<br>reduce the risk of the<br>formation of deep venous<br>thrombosis (DVT) by aiding<br>blood flow back to the heart<br>via lower extremity limb<br>compression. | Treatment of disorders<br>associated with vascular or<br>lymphatic insufficiency such<br>as Chronic Venous<br>Insufficiency (CVI), venous<br>stasis ulcers,<br>post-mastectomy edema and<br>chronic lymphedema.<br><br>Reduction of Edema<br>associated with soft tissue<br>injuries such as bums,<br>postoperative edema, and<br>ligament sprains.<br><br>Localized thermal therapy<br>(hot or cold) for post traumatic<br>and post surgical medical<br>and/or surgical conditions.<br><br>Decrease the risk of deep<br>venous thrombosis (DVT).<br><br>Aids the blood flow back to<br>the heart. | Therm-X (subject device)<br>indications for use are<br>identical to Therm-X<br>(K231912) with the only<br>difference being that the<br>Therm-X (subject device)<br>also indicates that the<br>device may be used for<br>treatment of disorders<br>associated with vascular<br>or lymphatic insufficiency<br>such as lymphedema and<br>CVI.<br><br>The indications for use for<br>the treatment of disorders<br>associated with vascular<br>or lymphatic insufficiency<br>such as lymphedema and<br>CVI of Therm-X (subject<br>device) are equivalent to<br>the VascuThermTM<br>(K061866) indications for<br>treatment of these same<br>disorders. |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| | X Home systems with DVT therapy are intended to reduce the risk of the formation of deep venous thrombosis (DVT) and by aiding blood flow back to the heart via lower extremity limb compression.<br><br>Therm-X (Therm-X Home 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. | Therm-X (Therm-X Home 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. | Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications. | |
| Intended Users | Health Care Professionals and lay users (under prescription) | Health Care Professionals and lay users (under prescription) | Health Care Professionals and lay users (under prescription) | Therm-X (subject device) is identical to Therm-X (K231912) and VascuTherm™ (K061866). |
| Number of<br>Patients that can<br>be treated at one<br>time | Two | Two | One | Therm-X (subject device) is identical to Therm-X (K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Two<br>Programmable<br>Cycles | Configuration of two<br>programmable cycles are<br>available for all Therm-X<br>Models | Configuration of two<br>programmable cycles are<br>available for all Therm-X<br>Models | Not Available. | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912). |
| Continuous<br>Treatment Cycle | Available on Therm-X Home | Available on Therm-X Home | Available. | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912) and<br>VascuTherm™<br>(K061866). |
| Heat Therapy | Default: 105°F, 107°F, 110°F<br>Custom: 105°F – 110°F<br>Default, continuous: 105°F,<br>107°F<br>Custom, continuous: 105°F –<br>107°F | Default: 105°F, 107°F, 110°F<br>Custom: 105°F – 110°F<br>Default, continuous: 105°F,<br>107°F<br>Custom, continuous: 105°F –<br>107°F | 105°F | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912) and equivalent<br>to VascuTherm™<br>(K061866). . |
| Cold Therapy | Default: 34°F, 45°F, 55°F<br>Custom: 34°F - 55°F<br>Default, continuous: 40°F,<br>45°F, 50°F<br>Custom, continuous: 40°F –<br>50°F | Default: 34°F, 45°F, 55°F<br>Custom: 34°F - 55°F<br>Default, continuous: 40°F,<br>45°F, 50°F<br>Custom, continuous: 40°F –<br>50°F | 43 - 49°F | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm ™<br>(VascuTherm ™ 4 and<br>VascuTherm ™ 5) and<br>NanoTherm ™) (K061866) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| Edema Pressure<br>Levels | Available in four levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous treatment,<br>available in three levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg) | Available in four levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous treatment,<br>available in three levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg) | Available in three levels:<br>Low (15 mmHg)<br>Medium (30 mmHg)<br>High (50 mmHg) | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912). |
| Static or<br>Intermittent<br>Pressure | Both | Both | Both | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912) and<br>VascuTherm™<br>(K061866) |
| DVT Only | Available for Therm-X Home<br>Model | Available for Therm-X Home<br>Model | Available | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912) and<br>VascuTherm™<br>(K061866). |
| DVT Pressure | Calf: 50 - 70 mmHg<br>Foot: 90 - 130 mmHg | Calf: 50 - 70 mmHg<br>Foot: 90 - 130 mmHg | Calf: 45 mmHg<br>Foot: 100 mmHg | Therm-X (subject device)<br>is identical to Therm-X<br>(K231912). |
| Characteristic | Therm-X | Therm-X (K231912) | VascuTherm™<br>(VascuTherm™ 4 and<br>VascuTherm™ 5) and<br>NanoTherm™) (K061866) | Comparison |
| |…