Therm-X

K193550 · Zenith Technical Innovations · IRP · Feb 28, 2020 · Physical Medicine

Device Facts

• Record ID: K193550
• Device Name: Therm-X
• Applicant: Zenith Technical Innovations
• Product Code: IRP · Physical Medicine
• Decision Date: Feb 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• 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 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 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 for thermal and compression therapy. It uses a centralized coolant reservoir, pumps, fans, and thermoelectric modules to circulate fluid through flexible, reusable or single-patient garments applied to the back, elbow, shoulder, ankle, hip, or knee. The system provides cold, heat, contrast (alternating), and pneumatic compression. Therm-X Home models additionally provide DVT prophylaxis via foot or calf compression. Operated via a touch-screen interface, users adjust treatment time, temperature, and compression settings. The device is used in clinical or home settings under professional supervision. By managing localized temperature and applying pneumatic pressure, the device aims to reduce edema, swelling, and pain, and prevent DVT. Healthcare providers use the device to deliver prescribed physical medicine treatments, potentially improving patient recovery outcomes.

Clinical Evidence

Bench testing only. IRB-approved study on healthy volunteers measured minimum skin temperature (40°F) to ensure no thermal damage under worst-case conditions. Human factors/usability assessments in simulated environments confirmed safe operation by intended users. No clinical efficacy trials were required.

Technological Characteristics

Thermoelectric heating/cooling; pneumatic compression. Materials: 30/200 denier nylon coated in urethane. Dimensions: 15"x10.5"x9". Power: 100-240 VAC, 50/60 Hz. Connectivity: Standalone with touch-screen interface. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1/5/10. Non-sterile. Software-controlled.

Indications for Use

Indicated for post-surgical and acute injuries to reduce edema, swelling, and pain via cold and compression; post-traumatic and post-surgical conditions requiring localized thermal therapy (hot or cold); and DVT prophylaxis (Therm-X Home only) to reduce DVT risk by aiding blood flow 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 (K190854)
• Therm-X (K181149)

Reference Devices

• Game Ready GRPro 2.1 System (K192114)
• Med4 Elite (K171685)

Submission Summary (Full Text)

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February 28, 2020

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

Re: K193550

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: December 19, 2019 Received: December 20, 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.

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/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K193550

Device Name

Therm-X

#### Indications for Use (Describe)

Therm-X (Therm-X Home 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 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.

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

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

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

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## 510(k) Summary

# Zenith Technical Innovations K193550

| 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 |
| Date Prepared: | December 19, 2019 |

## Device Name and Classification

| Trade Name: | Therm-X |
|-----------------------|---------------------------------------------------|
| Common Name: | Massager, Powered Inflatable Tube |
| Classification: | Class II |
| Regulation Number: | 21 CFR 890.5650, Powered inflatable tube massager |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, ILO, JOW |

# Predicate Devices

| Predicate: | Primary | Secondary | Reference |
|----------------------------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------------------|
| Trade Name: | Therm-X | Therm-X | Game Ready GRPro<br>2.1 System |
| Common<br>Name: | Heat and/or Cold and<br>Compression Therapy | Heat and/or Cold and<br>Compression Therapy | Powered Inflatable<br>Tube Massager |
| 510(k)<br>Submitter /<br>Holder: | Zenith Technical<br>Innovations, LLC.<br>(Zenith) | Zenith Technical<br>Innovations, LLC.<br>(Zenith) | Cool Systems, Inc.<br>(dba Game Ready) |
| 510(k) Number: | K190854 | K181149 | K192114 |
| Classification: | Class II | Class II | Class II |
| Regulation<br>Number: | 890.5650, Powered<br>Inflatable tube<br>massager | 890.5650, Powered<br>Inflatable tube<br>massager | 890.5650, Powered<br>Inflatable tube<br>massager |
| Classification<br>Panel: | Physical Medicine | Physical Medicine | Physical Medicine |
| Product Code: | IRP, ILO, JOW | IRP, ILO, JOW | IRP, 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 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 consists of various reusable inflatable wraps for thermal treatment of the back, elbow, shoulder, ankle, hip, or knee and DVT prophylactic treatment applied to the foot or calf. Multipatient 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 shoulder, 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 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 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 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 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 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.

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## Risk Analysis Method

The Therm-X was assessed to determine the risks to health associated with the device modifications 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. All risks have been found acceptable.

### Substantial Equivalence

Therm-X is substantially equivalent to Therm-X (K181149, K190854) by Zenith Technical Innovations, LLC. (Zenith) and Game Ready GRPro 2.1 System (K192114) by Cool Systems, Inc. (dba Game Ready) 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><br>Subject Device | Therm-X (K190854)<br><br>Primary Predicate | Therm-X (K181149)<br><br>Secondary Predicate | GameReady®<br>GRPro 2.1 System<br>(K192114)<br><br>Reference Device | Comparison |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Therm-X (Therm-X Home 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 Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy are | 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- | 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- | Game Ready® GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where 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 (subject device) are identical to the Therm-X (K190854) with the only difference being that 1 model name has changed, and 1 model has been discontinued. |
| Characteristic | Therm-X<br>Subject Device | Therm-X (K190854)<br>Primary Predicate | Therm-X (K181149)<br>Secondary<br>Predicate | GameReady®<br>GRPro 2.1 System<br>(K192114)<br>Reference Device | Comparison |
| | 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. | 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. | 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. | | |
| | Therm-X (Therm-X<br>Home and Therm-X<br>AT) is intended to be<br>used by, or on the<br>order of, licensed<br>health care<br>professionals in<br>rehabilitation<br>facilities, outpatient<br>clinics, athletic<br>training settings, and<br>home 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>health care<br>professionals in<br>rehabilitation<br>facilities, outpatient<br>clinics, athletic<br>training settings, and<br>home 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>health care<br>professionals in<br>rehabilitation<br>facilities, outpatient<br>clinics, athletic<br>training settings, and<br>home settings. | | |
| Characteristic | Therm-X<br>Subject Device | Therm-X (K190854)<br>Primary Predicate | Therm-X (K181149)<br>Secondary<br>Predicate | GameReady®<br>GRPro 2.1 System<br>(K192114)<br>Reference Device | Comparison |
| Intended Users | Health Care<br>Professionals and lay<br>users (under<br>prescription) | Health Care<br>Professionals and lay<br>users (under<br>prescription) | Health Care<br>Professionals and lay<br>users (under<br>prescription) | Healthcare<br>professionals,<br>athletic trainers, lay<br>users under the<br>direction of a<br>healthcare<br>professional | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Number of<br>Patients that can<br>be treated at one<br>time | One | One | One | One | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| 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<br>are available for all<br>Therm-X Models | Configuration of two<br>programmable cycles<br>are available for all<br>Therm-X Models | Not publicly<br>available. | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Functions | | | | | |
| Continuous<br>Treatment Cycle | Available on Therm-<br>X Home | Not Available | Not Available | Not publicly available | Therm-X (subject<br>device) is equivalent<br>to GameReady®<br>GRPro 2.1 System<br>(K192114). |

# Detailed Comparison of the Subject and Predicate Device

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| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®<br>GRPro 2.1 System<br>(K192114) | Comparison |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary<br>Predicate | Reference Device | |
| Heat Therapy | Default: 105°F,<br>107°F, 110°F<br>Custom: 105°F –<br>110°F<br>Default, continuous:<br>105°F, 107°F<br>Custom, continuous:<br>105°F – 107°F | Default: 105°F,<br>107°F, 110°F<br>Custom: 105°F –<br>110°F | Default: 105°F,<br>107°F, 110°F<br>Custom: 105°F –<br>110°F | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br>The only difference<br>is that the heat<br>therapy<br>temperatures are<br>more limited for<br>continuous<br>treatment, but fall<br>within the range of<br>what has been<br>previously cleared. |

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| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®<br>GRPro 2.1 System<br>(K192114) | Comparison |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Secondary<br>Predicate | Reference Device | |
| Cold Therapy | Default: 34°F, 45°F,<br>55°F<br>Custom: 34°F - 55°F<br>Default, continuous:<br>40°F, 45°F, 50°F<br>Custom, continuous:<br>40°F - 50°F | Default: 34°F, 45°F,<br>55°F<br>Custom: 34°F - 55°F | Default: 34°F, 45°F,<br>55°F<br>Custom: 34°F - 55°F | 34 - 50°F | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br>The only difference<br>is that the cold<br>therapy<br>temperatures are<br>more limited for<br>continuous<br>treatment, but fall<br>within the range of<br>what has been<br>previously cleared. |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®<br>GRPro 2.1 System<br>(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary<br>Predicate | Reference Device | |
| Edema Pressure<br>Levels | Available in four<br>levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>For continuous<br>treatment, available<br>in three levels:<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Available in three<br>levels:<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | Available in three<br>levels:<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 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 Hg) | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br>The only difference<br>is that the pressure<br>levels are more<br>limited for<br>continuous<br>treatment and an<br>additional<br>compression level<br>(lite) has been<br>included. |
| Static or<br>Intermittent<br>Pressure | Both | Static Pressure Only | Static Pressure Only | Intermittent Pressure<br>available | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854) and<br>GameReady®<br>GRPro 2.1 System<br>(K192114). |
| DVT Only | Available for Therm-<br>X Home Model | Available for Therm-<br>X Pro Athlete and<br>Therm-X Pro Models | Available for Therm-<br>X Pro Athlete and<br>Therm-X Pro Models | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®<br>GRPro 2.1 System<br>(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary Predicate | Reference Device | |
| DVT Pressure | Calf: 50 - 70 mmHg<br>Foot: 90 - 130<br>mmHg | Calf: 50 - 70 mmHg<br>Foot: 100 - 130<br>mmHg | Calf: 50 - 70 mmHg<br>Foot: 100 – 130<br>mmHg | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854). |
| Cycle Length<br>(for Heat, Cold,<br>and<br>Compression) | Default: 10 or 20<br>minutes<br>Custom: 3 – 40<br>minutes<br>Continuous: 10 - 40<br>minutes active, 30-60<br>minutes rest | Heat: 20, 30, or 40<br>minutes<br>Cold: 20, 30, or 40<br>minutes<br>Compression: 20, 30,<br>or 40 minutes | Heat: 20, 30, or 40<br>minutes<br>Cold: 20, 30, or 40<br>minutes<br>Compression: 20, 30,<br>or 40 minutes | 15 minutes default,<br>increasing or<br>decreasing in 5-<br>minute increments to<br>a max of 90 min or a<br>min of 5 min. | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br>The only difference<br>is that a custom and<br>continuous cycle<br>length is available<br>for the Therm-X<br>Home model.<br>Verification and<br>validation testing<br>has been performed<br>to test the<br>continuous<br>treatment cycle.<br>Note: K192114 does<br>not offer heat<br>therapy. |
| Characteristic | Therm-X<br>Subject Device | Therm-X (K190854)<br>Primary Predicate | Therm-X (K181149)<br>Secondary Predicate | GameReady®<br>GRPro 2.1 System<br>(K192114)<br>Reference Device | Comparison |
| Contrast<br>Therapy | Available for Therm-<br>X AT Model only<br><br>Heat: 105°F<br><br>Cold: 38°F | Available for all<br>Therm-X Models<br><br>Heat: 105°F<br><br>Cold: 38°F | Available for all<br>Therm-X Models<br><br>Heat: 105°F<br><br>Cold: 38°F | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br><br>The only difference<br>is that the contrast<br>therapy is only<br>available for Therm-<br>X AT Model and not<br>for Therm-X Home<br>Model. |
| Cycle Length<br>(for Contrast<br>Therapy) | Heat: 3-10 minutes<br><br>Cold: 3-10 minutes<br><br>Total treatment: 6-60<br>minutes | Heat: 10 minutes<br><br>Cold: 10 minutes<br><br>Total treatment: 5<br>cycles of alternating<br>heat and cold<br>treatment for total<br>duration of 100<br>minutes | Heat: 10 minutes<br><br>Cold: 10 minutes<br><br>Total treatment: 5<br>cycles of alternating<br>heat and cold<br>treatment for total<br>duration of 100<br>minutes | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854). |
| DVT Cycle<br>Length | No specified time<br>interval. DVT can be<br>stopped at any time<br>by the user. | No specified time<br>interval. DVT can be<br>stopped at any time<br>by the user. | No specified time<br>interval. DVT can be<br>stopped at any time<br>by the user. | N/A | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Characteristic | Therm-X<br><i>Subject Device</i> | Therm-X (K190854)<br><i>Primary Predicate</i> | Therm-X (K181149)<br><i>Secondary Predicate</i> | GameReady® GRPro 2.1 System<br>(K192114)<br><i>Reference Device</i> | Comparison |
| Edema Compression<br>and DVT Compression at<br>the same time | Available<br><br>Edema Compression<br>(Lite, Low, Medium, High) must be<br>combined with cold,<br>heat, or contrast<br>therapy | Available<br><br>Edema Compression<br>(Low, Medium, High)<br>must be combined<br>with cold, heat, or<br>contrast therapy | Available<br><br>Edema Compression<br>(Low, Medium, High)<br>must be combined<br>with cold, heat, or<br>contrast therapy | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854).<br><br>Note: K192114 does<br>not provide DVT. |
| DVT Inflation<br>and Deflation | DVT Inflation: Up to<br>120 seconds<br><br>DVT Deflation: Up to<br>30 seconds | DVT Inflation: Up to<br>60 seconds<br><br>DVT Deflation: Up to<br>30 seconds | DVT Inflation: Up to<br>60 seconds<br><br>DVT Deflation: Up to<br>30 seconds | N/A | Therm-X (subject<br>device) is equivalent<br>to Therm-X<br>(K190854). |
| Power Down | Available | Available | Available | Sleep option | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Password<br>Protection | Available | Available for Therm-<br>X AT and Therm-X<br>Pro Models. | Available for Therm-<br>X AT and Therm-X<br>Pro Models. | Not publicly available | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Store Cycle<br>Usage Data | Available | Available | Available | Not publicly available | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Physical Unit | | | | | |
| Dimensions | 15" L x 10.5" W x 9"<br>H | 15" L x 10.5" W x 9"<br>H | 15" L x 10.5" W x 9"<br>H | 16.25" L x 7.75" W x<br>9.25 H (413 x 197 x<br>235) mm (not<br>including carrying<br>case) | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Characteristic | Therm-X | Therm-X (K190854) | Therm-X (K181149) | GameReady®<br>GRPro 2.1 System<br>(K192114) | Comparison |
| | Subject Device | Primary Predicate | Secondary<br>Predicate | Reference Device | |
| Weight | 15 lbs. when full of<br>coolant | 15 lbs. when full of<br>coolant | 15 lbs. when full of<br>coolant | 7.3 lbs. (3.31 kg.)<br>empty,<br>Approximately 18 Ibs<br>full of ice and water<br>but less when filled<br>per instructions for<br>use | Therm-X (subject<br>device) is identical<br>to Therm-X<br>(K190854). |
| Chilling<br>Mechanism | Thermoelectric | Thermoelectric | Thermoelectric…