Therm-X

K190854 · Zenith Technical Innovations · IRP · May 10, 2019 · Physical Medicine

Device Facts

• Record ID: K190854
• Device Name: Therm-X
• Applicant: Zenith Technical Innovations
• Product Code: IRP · Physical Medicine
• Decision Date: May 10, 2019
• Decision: SESE
• Submission Type: Abbreviated
• 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-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.

Device Story

Therm-X is an AC-powered, software-controlled multimodality device for cold, heat, contrast, and compression therapy; includes DVT prophylaxis on Pro/Pro Athlete models. System uses reusable inflatable garments (back, elbow, shoulder, ankle, knee, foot, calf) connected to a centralized coolant reservoir. Device features thermoelectric heating/cooling and pneumatic compression pumps. Operated via touch screen interface; allows adjustment of treatment time, temperature, and compression. Includes password protection for home-use compliance. Used in clinics or home settings under professional supervision. Healthcare providers assign treatment cycles; output affects patient edema, pain, and DVT risk. Benefits include localized thermal therapy and blood flow enhancement. Device is 15 lbs; requires low-level disinfection for multi-patient reuse.

Clinical Evidence

Bench testing only. Validated cleaning and low-level disinfection processes for reusable garments. Durability accelerated aging tests confirmed garment integrity over expected life. Human factors validation study confirmed users can correctly follow cleaning/disinfection instructions.

Technological Characteristics

Thermoelectric heating/cooling; pneumatic compression. Materials: 30 denier nylon (thermal garments), 200 denier nylon (DVT garments). Dimensions: 15"x10.5"x9". Power: 100-240 VAC, 50/60 Hz. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2. Software-controlled via touch screen. Multi-patient use via low-level disinfection.

Indications for Use

Indicated for patients requiring cold, heat, contrast, or compression therapy for post-surgical/acute injury edema, swelling, and pain reduction. Therm-X Pro/Pro Athlete models indicated for DVT prophylaxis via lower extremity compression. Intended for use by or on order of licensed healthcare professionals in rehab, clinics, athletic training, or home settings.

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

• Therm-X (K181149)
• Med4 Elite™ (K171685)
• VascuTherm™ (and NanoTherm™) (K061866)

Reference Devices

• IC-BAP-DL BioArterial Plus Arterial Blood Flow Enhancement System (K131327)

Submission Summary (Full Text)

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May 10, 2019

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

Re: K190854

Trade/Device Name: Therm-X Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO, JOW Dated: April 1, 2019 Received: April 2, 2019

### 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.

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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/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 mediation-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,

Vivek Pinto, PhD Assistant Director Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K190854

Device Name Therm-X

#### 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 intended to treat 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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Zenith Therm-X Abbreviated 510(k)

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# 510(k) Summary

# Zenith Technical Innovations K190854

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 Technical Officer<br>[e-mail] |
| Date Prepared: | May 6, 2019 |

# 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 |
|----------------------------|--------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------|
| Trade Name: | Therm-X | Med4 Elite™ | VascuTherm™ (and NanoTherm™ ) |
| Common Name: | Heat and/or Cold<br>and Compression<br>Therapy | Heat and/or Cold<br>and Compression<br>Therapy | Intermittent, External<br>Pneumatic<br>Compression Device |
| 510(k) Submitter / Holder: | Zenith Technical<br>Innovations, LLC | CoolSystems, Inc. | ThermoTek, Inc. |
| 510(k) Number: | K181149 | K171685 | K061866 |
| Classification: | Class II | Class II | Class II |
| Regulation Number: | 890.5650, Powered<br>inflatable tube<br>massager | 890.5650, Powered<br>Inflatable tube<br>massager | 870.5800, Compressible<br>limb sleeve |
| Classification Panel: | Physical Medicine | Physical Medicine | Cardiovascular |
| Product Code: | IRP, ILO, JOW | IRP, ILO | JOW, ILO |

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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 three configurations: 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 reusable 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 cycle 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.

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 system are located inside a covered enclosure made out of plastic and metal components, accessible only using a specialized tool.

Therm-X is a class II medical device per FDA classification and has been previously cleared by the FDA under K181149. The Therm-X single-patient use garments under K181149 have been changed to multi-patient use garments through the use of a low-level disinfection process. Based on the guidance "Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015), the Therm-X garments are considered reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., disinfect) the device for initial use, as well as to reprocess the device after each use. The qarments are considered non-critical devices in that they contact only intact skin and do no penetrate it. Therm-X garments may become contaminated with microorganisms and organic soil during patient care and such contamination may not be visible. To account for this contamination and to prevent patient harm when used with multiple patients, Zenith uses a low-level disinfection process for the Therm-X garments.

### Indications for Use

The indications for use for the Therm-X system (K190854) have not changed since the device was cleared (K181149) and are as follows:

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

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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 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.

### Risk Analysis Method

Therm-X (including reusable garments) was assessed to determine the risks to health associated with the use of the device and evaluate 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, and improper use.

### Substantial Equivalence

Therm-X (K190854) is substantially equivalent to Therm-X by Zenith (K181149), Med4 Elite by Coolsystems, Inc. (K171685) and VascuTherm by ThermoTek, Inc. (K061866), currently on the market.

Therm-X (K190854) has the same indications for use as Therm-X (K181149).

Therm-X (K190854), Med4 Elite™ and VascuTherm™ all provide reusable garments.

Therm-X (K190854), Therm-X (K181149), Med4 Elite™ and VascuTherm™ provide non-sterile garments.

There are no differences in the technology between Therm-X (K190854) and Therm-X (K181149). The primary differences of the technology of the Therm-X device with the predicate devices are discussed below.

The following table provides side by side comparison of Therm-X with the predicate devices.

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Detailed Comparison of the Subject and Predicate Devices

| Characteristic | Therm-X<br>(this submission - K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary Predicate | VascuTherm™<br>(and NanoTherm™)<br>(K061866)<br>Secondary Predicate | Comparisons |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>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.<br><br>Therm-X Pro and Therm-X Pro Athlete systems also provide DVT | 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.<br><br>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 | 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 | 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.<br><br>Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.<br><br>Decrease the risk of deep venous thrombosis (DVT).<br><br>Aids the blood flow back to the heart. | The indications for use of Therm-X (K190854) are identical to the primary predicate, Therm-X (K181149).<br><br>The indications for use of Therm-X (K190854) 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) (K190854) are also identical to VascuTherm™ for DVT therapy with the only difference being that VascuTherm™ is not used in home settings. |
| Characteristic | Therm-X<br>(this submission - K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite ™<br>(K171685)<br>Secondary Predicate | VascuTherm ™<br>(and NanoTherm ™)<br>(K061866)<br>Secondary Predicate | Comparisons |
| 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.<br>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 | aiding blood flow back to the heart via lower extremity limb compression.<br>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. | rehabilitation facilities, outpatient clinics, and athletic training 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. | | |
| Characteristic | Therm-X<br>(this submission<br>- K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary<br>Predicate | VascuTherm™<br>(and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Comparisons |
| Intended Users | Health Care<br>Professionals and<br>lay users (under<br>prescription) | Health Care<br>Professionals and lay<br>users (under<br>prescription) | Health Care<br>Professionals only<br>(Prescription use) | Health Care<br>Professionals only<br>(Prescription use) | The intended users of<br>Therm-X (K190854)<br>are identical to the<br>primary predicate,<br>Therm-X (K181149).<br><br>Therm-X (K190854)<br>intended users are<br>equivalent to the Med4<br>Elite™ and<br>VascuTherm™ with<br>the only difference<br>being that the intended<br>users for the Med4<br>Elite™ and<br>VascuTherm do not<br>include lay users in the<br>home setting. |
| Number of<br>Patients that<br>can be treated<br>at one time | One | One | Two | One | Therm-X (K190854) is<br>identical to the primary<br>predicate, Therm-X<br>(K181149).<br><br>Therm-X (K190854) is<br>designed to treat one<br>patient at a time and it<br>is identical to the<br>VascuTherm™. |
| Characteristic | Therm-X<br>(this submission<br>- K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary<br>Predicate | VascuTherm™<br>(and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Comparisons |
| Two<br>Programmable<br>Cycles | Configuration of<br>two<br>programmable<br>cycles are<br>available for all<br>Therm-X Models | Configuration of two<br>programmable cycles<br>are available for all<br>Therm-X Models | Not Available | Not Available | Therm-X (K190854)<br>is identical to the<br>primary predicate,<br>Therm-X (K181149). |
| Heat Therapy | Default: 105, 107,<br>110°F<br>Custom: 105°F –<br>110°F | Default: 105, 107, 110°F<br>Custom: 105°F – 110°F | 95 – 113°F (35 –<br>45°C) | 105°F | Therm-X (K190854)<br>is identical to the<br>primary predicate,<br>Therm-X (K181149).<br>The Therm-X<br>(K190854) Heat<br>Therapy Temperature<br>Range is equivalent<br>to the Med4 Elite™. |
| Cold Therapy | Default: 34, 45,<br>55°F<br>Custom: 34 –<br>55°F | Default: 34, 45, 55°F<br>Custom: 34 – 55°F | 38 – 60°F (3.33<br>– 15.56°C) | 43 – 49°F | Therm-X (K190854) is<br>identical to the primary<br>predicate, Therm-X<br>(K181149).<br>The Therm-X<br>(K190854) temperature<br>range for Cold Therapy<br>is equivalent to the<br>Med4 Elite™. The<br>Therm-X (K190854)<br>maximum temperature<br>range for Cold Therapy<br>is equivalent to<br>Med4Elite™. |
| Characteristic | Therm-X<br>(this submission - K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary Predicate | VascuTherm™<br>(and NanoTherm™)<br>(K061866)<br>Secondary Predicate | Comparisons |
| Edema Pressure<br>Levels | Available in three<br>levels<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Available in three levels<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Available in four<br>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 Hg)<br>High (50 mm Hg) | Therm-X (K190854) is identical to the<br>primary predicate, Therm-X (K181149).<br><br>The edema pressure levels for Therm-X<br>(K190854) are equivalent to the<br>pressure levels for the Med4Elite™.<br><br>Therm-X (K190854) like VascuTherm™<br>provides constant values for Low,<br>Medium and High compression. |
| DVT Only | Available for Therm-X Pro<br>Athlete and Therm-X Pro<br>Models. | Available for Therm-X Pro Athlete and Therm-<br>X Pro Models. | Not Available | Available | Therm-X (K190854) is identical to the<br>primary predicate, Therm-X (K181149).<br><br>Therm-X Pro Athlete and Therm-X Pro<br>Models (K190854) are identical to<br>VascuTherm™ |
| Characteristic | Therm-X<br>(this submission<br>- K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary<br>Predicate | VascuTherm™<br>(and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Comparisons |
| DVT Pressure | Calf: 50 - 70 mm<br>Hg<br>Foot: 100 - 130<br>mm Hg | Calf: 50 - 70 mm Hg<br>Foot: 100 – 130 mm Hg | Not available | Calf: 45 mm Hg<br>Foot: 100 mm Hg | Therm-X (K190854)<br>is identical to the<br>primary predicate,<br>Therm-X (K181149).<br>Therm-X (K190854)<br>has a higher range for<br>Foot and Calf DVT<br>pressures than the<br>VascuTherm™ and<br>has equivalent DVT<br>pressure to<br>reference predicate,<br>IC-BAP-DL BioArterial<br>Plus Arterial Blood<br>Flow Enhancement<br>System (K131327). |
| Cycle Length<br>(for Heat, Cold<br>and<br>Compression) | Heat: 20, 30, or 40<br>minutes<br>Cold: 20, 30, or 40<br>minutes<br>Compression: 20,<br>30, or 40 minutes | Heat: 20, 30, or 40<br>minutes<br>Cold: 20, 30, or 40<br>minutes<br>Compression: 20, 30, or<br>40 minutes | Heat: 5 to 30<br>minutes, 15 minutes<br>default<br>Cold: 5 to 60<br>minutes, 15 minutes<br>default<br>Compression: 5 to<br>60 minutes, 15<br>minutes default | Heat: 30 minutes<br>(presumed - not<br>clearly stated in User<br>Manual)<br>Cold: 30 minutes<br>(presumed not clearly<br>stated in User Manual)<br>Compression:<br>Unkown | Therm-X (K190854)<br>is identical to the<br>primary predicate,<br>Therm-X (K181149).<br>The Therm-X<br>(K190854) Cycle<br>length for Heat, Cold<br>and Compression is<br>equivalent to Med4<br>Elite™ |
| Characteristic | Therm-X<br>(this submission<br>- K190854) | Therm-X (K181149)<br>Primary predicate | Med4 Elite™<br>(K171685)<br>Secondary<br>Predicate | VascuTherm™<br>(and<br>NanoTherm™)<br>(K061866)<br>Secondary<br>Predicate | Comparisons |
| Contrast<br>Therapy (for<br>Heat, Cold and<br>Compression) | Available<br>Heat: 10 minutes<br>Cold: 10 minutes<br>Total treatment: 5<br>cycles of<br>alternating heat<br>and cold<br>treatment for total<br>duration of 100<br>minutes | Available<br>Heat: 10 minutes<br>Cold: 10 minutes<br>Total treatment: 5<br>cycles of alternating<br>heat and cold treatment<br>for total duration of 100<br>minutes | Available<br>Heat: 1 - 10<br>minutes, default 3<br>minutes<br>Cold: 1 - 10<br>minutes, default 3<br>minutes<br>Total treatment:<br>15 – 90 minutes,<br>default 30<br>minutes | Available<br>Heat: 10 minutes<br>Cold: 20 minutes | Therm-X (K190854)<br>is identical to the<br>primary predicate,<br>Therm-X (K181149).<br><br>Therm-X (K190854)<br>Contrast therapy<br>function is equivalent<br>to the Med4 Elite™. |
| Characteristic | Therm-X<br>(this submission<br>- K190854) | Therm-X (K181149)<br>Primary predicate…