Cryo-Thermo Compression Device (FGK002)

K222136 · Suzhou Microport Rehabtech (Group) Co., Ltd. · IRP · Mar 8, 2023 · Physical Medicine

Device Facts

• Record ID: K222136
• Device Name: Cryo-Thermo Compression Device (FGK002)
• Applicant: Suzhou Microport Rehabtech (Group) Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cryo-Thermo Compression Device combines cold, heat and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.

Device Story

AC-powered, software-controlled device for rehabilitation/clinical settings; operated by healthcare professionals. Inputs: user-defined settings via touch screen (temperature, compression level, time). Operation: thermoelectric system circulates coolant (distilled water/ethanol) through inflatable wraps (elbow, shoulder, ankle, hand-wrist, knee) to provide cold/heat and intermittent pneumatic compression. Output: localized thermal and compression therapy. Benefits: reduces edema, swelling, and pain; aids recovery. Healthcare providers use output to manage patient therapy sessions. Device includes main control unit, hose, and power cable.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1, -5, -10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V, and functional performance testing (temperature/pressure/timing accuracy, flow rate, seam strength, hose integrity). Skin temperature testing on healthy volunteers confirmed no thermal/cold injury risk.

Technological Characteristics

Thermoelectric heating/cooling; intermittent pneumatic compression. Materials: nylon 6, T/C cloth, polyester brushed fabric, ABS plastic. Dimensions: 34.8x14.6x28.0cm. Weight: 8kg (full). Connectivity: standalone, touch screen interface. Power: 100-240 VAC, 60 Hz. Software: moderate level of concern, IEC 62304 compliant.

Indications for Use

Indicated for adults (>21 years) with post-surgical or acute injuries requiring edema, swelling, and pain reduction via cold and compression, or post-traumatic/post-surgical conditions requiring localized thermal therapy.

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 (K193550)
• Med4 Elite™ (K171685)

Submission Summary (Full Text)

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March 8, 2023

Suzhou MicroPort RehabTech (Group) Co., Ltd. % Yunfang Sun Senior Specialist, Regulatory Affairs MicroPort Sinica Co., Ltd. No. 1601 ZhangDong Rd, ZJ Hi-Tech Park Shanghai, 201203 China

Re: K222136

Trade/Device Name: Cryo-Thermo Compression Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: January 13, 2023 Received: January 13, 2023

Dear Yunfang Sun:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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.

# Heather L. Dean -S

Heather Dean, 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) K222136

Device Name Cryo-Thermo Compression Device

#### Indications for Use (Describe)

Cryo-Thermo Compression Device combines cold, heat and compression therapies.

It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training 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

| 510(k) Submitter: | Suzhou MicroPort RehabTech (Group) Co., Ltd.<br>Part of building3#, 112 Fangzhong Street, Suzhou<br>Industrial Park,201203 Suzhou, PEOPLE'S<br>REPUBLIC OF CHINA |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Liang Hong<br>[e-mail]<br>Phone: [phone]-2257 |
| Date Prepared : | January 11, 2023 |
| Device Name: | Cryo-Thermo Compression Device |
| Device Classification Name: | Powered Inflatable Tube Massager |
| Regulation Number: | 21 CFR 890.5650 |
| Classification Panel: | Physical Medicine |
| Classification Product Code: | IRP, ILO |
| Device Class: | Class II |

## 1. Substantial Equivalence Claimed To

Cryo-Thermo Compression Device is substantially equivalent to Therm-X cleared under (K193550) and Med4 Elite™ cleared under K171685. The predicate devices are listed in Table 1.

| Comparison Device | Primary Predicate Device | Secondary Predicate Device |
|--------------------------|------------------------------------|------------------------------------------|
| Trade Name: | Therm-X | Med4 Elite™ |
| Common Name: | Massager, Powered Inflatable Tube | Heat and/or Cold and Compression Therapy |
| 510(k) Number: | K193550 | K171685 |
| 510(k) Submitter/Holder: | Zenith Technical Innovations, LLC. | Cool Systems, Inc. |
| Classification: | Class II | Class II |
| Regulation Number: | 21 CFR 890.5650 | 21 CFR 890.5650 |

Table 1 Table of Predicates

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| Classification Panel: | Physical Medicine | Physical Medicine |
|-----------------------|-------------------|-------------------|
| Product Code: | IRP, ILO, JOW | IRP, ILO |

### 2. Indication for Use

Cryo-Thermo Compression Device combines cold, heat and compression therapies.

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

It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.

### 3. Intended Use Population

Cryo-Thermo Compression Device is intended for adults only (greater than 21 years of age).

### 4. Device Description

Cryo-Thermo Compression Device. Model Number: FGK002. is an AC powered. software-controlled device, designed to be used in rehabilitation facilities, outpatient clinics and athletic training settings and under the direction, prescription, or supervision of a licensed healthcare professional.

Cryo-Thermo Compression Device features iceless cold therapy, heat therapy and intermittent pneumatic compression therapy.

Cryo-Thermo Compression Device provides various inflatable wraps for thermal treatment (heat or cold) of the elbow, shoulder, ankle, hand-wrist or knee. The wraps are reusable for a single patient and can be cleaned if necessary.

Cryo-Thermo Compression Device is controlled by a touch screen interface, allowing the user to manage in the therapy modalities as well as easily adjust treatment temperature, compression level and time settings.

Cryo-Thermo Compression Device consists of a main equipment, wraps and accessories. The main equipment includes a control unit, a hose and a power cable. The drainpipe and the ice stick are accessories which can be ordered upon request. It is approximately 17.641bs (8kg) when reservoir is full of coolant. And, it is recommended to use 10% ethanol with 90% distilled water as the coolant.

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### 5. Substantial Equivalence

The subject device, Cryo-Thermo Compression Device, is substantially equivalent to the primary predicate Therm-X (K193550) by Zenith Technical Innovations, LLC. (Zenith) and the secondary predicate Med4 Elite™ (K171685) by Cool Systems, Inc. currently on the market.

The table below provides a detailed comparison of the Cryo-Thermo Compression Device to predicate devices.

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| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Cryo-Thermo Compression<br>Device combines cold, heat<br>and compression therapies. | Therm-X (Therm-X Home<br>and Therm-X AT) combines<br>cold, heat, contrast, and<br>compression therapy. | The Med4 Elite™<br>combines cold, heat,<br>contrast and compression<br>therapies. | All three devices combine<br>cold, heat and compression<br>therapies, the Cryo-Thermo<br>Compression Device does<br>not provide contrast therapy<br>compared to predicate<br>devices Therm-X and Med4<br>Elite™. |
| | It 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<br>localized thermal therapy<br>(hot or cold) are indicated. | Therm-X is intended to treat<br>post-surgical and acute<br>injuries to reduce edema,<br>swelling, and pain for which<br>cold and compression are<br>indicated. It is intended to<br>treat post traumatic and post-<br>surgical medical and/or<br>surgical conditions for which<br>localized thermal therapy (hot<br>or cold) are indicated. | It is intended to treat post-<br>surgical and acute injuries<br>to reduce edema, swelling<br>and pain for which cold<br>and compression are<br>indicated. It is intended to<br>treat post traumatic and<br>post-surgical medical<br>and/or surgical conditions<br>for which localized<br>thermal therapy (hot or<br>cold or contrast) are<br>indicated. | Cryo-Thermo Compression<br>Device has the same<br>intended use as the<br>predicate devices Therm-X<br>and Med4 Elite™. |
| | It is intended to be used by,<br>or on the order of, licensed<br>healthcare professionals in<br>rehabilitation facilities,<br>outpatient clinics and | Therm-X Home systems also<br>provide DVT therapy. Therm-<br>X Home systems with DVT<br>therapy are intended to reduce | It is intended to be used<br>by, or on the order of, | The Cryo-Thermo<br>Compression Device is not<br>indicated for decreasing<br>risk of DVT and not used<br>in home setting, which is<br>covered by additional |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| | athletic training settings. | the risk of the formation of<br>deep venous thrombosis<br>(DVT) by aiding blood flow<br>back to the heart via lower<br>extremity limb compression.<br><br>Therm-X (Therm-X Home<br>and Therm-X AT) is intended<br>to be used by, or on the order<br>of, licensed health care<br>professionals in rehabilitation<br>facilities, outpatient clinics,<br>athletic training settings, and<br>home settings. | licensed healthcare<br>professionals in<br>rehabilitation facilities,<br>outpatient clinics, and<br>athletic training settings. | indications and<br>functionality of the Therm-<br>X Home. |
| Intended User | Health Care Professionals<br>only (Prescription use) | Health Care Professionals and<br>lay users (under prescription) | Health Care Professionals<br>only (Prescription use) | All three devices are<br>prescription use only. Cryo-<br>Thermo Compression<br>Device and secondary<br>predicate are only used by<br>health care professionals. |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| Number of<br>Patients that<br>can be treated<br>at one time | One | One | Two | Both subject device Cryo-Thermo Compression Device and primary predicate Therm-X are designed to treat one patient at a time. |
| Functions | | | | |
| Heat Therapy | 38°C (100.4°F) or 40°C<br>(104°F) | Default: 40.5°C ( 105°F ) ,<br>41.6°C ( 107°F ) , 43°C<br>(110°F ) ;<br>Custom: 40.5°C - 43°C<br>(105°F -110°F ) ;<br><br>Default, continuous:<br>40.5°C (105°F), 41.6°C<br>(107°F ) ;<br>Custom, continuous: 40.5°C-<br>41.6°C (105°F -107°F ); | 35°C - 45°C<br>(95°F -113°F) | The maximum temperature set point for heat therapy of Cryo-Thermo Compression Device is lower compared with the primary predicate Therm-X. Furthermore, the both temperature set points (38°C or 40°C) of Cryo-Thermo's heat therapy are within the temperature range of the secondary predicate Med4 Elite™.<br>There is no new safety and effectiveness issue. |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| Cold Therapy | 6°C -15°C (42.8°F-59°F), | Default: 1.1°C (34°F), 7.2°C<br>(45°F), 12.7°C (55°F);<br>Custom: 1.1°C -12.7°C (34°F-<br>55°F);<br><br>Default, continuous:<br>4.4°C (40°F), 7.2°C (45°F),<br>10°C (50°F);<br>Custom, continuous:<br>4.4°C - 10°C (40°F - 50°F); | 3.33°C -15.56°C<br>(38°F -60°F) | The minimum and<br>maximum temperature set<br>points for cold therapy of<br>Cryo-Thermo Compression<br>Device are higher<br>compared with the primary<br>predicate Therm-X.<br>Furthermore, the<br>temperature range for cold<br>therapy of Cryo-Thermo<br>can be covered by the<br>secondary predicate Med4<br>Elite™.<br><br>There is no new safety and<br>effectiveness issue. |
| Compression<br>range | Available in five levels:<br>Off (0mmHg),<br>Low (15mmHg),<br>Medium-Low (30mmHg),<br>Medium-High (50mmHg),<br>High (70mmHg) | 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><br>For continuous treatment. | Available in four levels:<br>Low (5 - 15 mm Hg),<br>Medium-Low (5 - 30 mm<br>Hg),<br>Medium (5 - 50 mmHg),<br>High (5 - 75 mmHg) | The Cryo-Thermo<br>Compression Device has a<br>same maximum<br>compression level as the<br>primary predicate Therm-<br>X, and the pressure value<br>available in each level can |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| | | available in three levels:<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg) | | be covered by the<br>secondary predicate Med4 Elite™ |
| Static or<br>Intermittent<br>Pressure | Intermittent<br>available | Static and Intermittent<br>Pressure | Intermittent<br>available | All the three devices can provide intermittent<br>pressure. |
| Treatment Time<br>Setting<br>(for Heat, Cold and<br>Compression) | Single Treatment time:<br>10 min - 40min | Default: 10 or 20 minutes<br>Custom: 3 - 40 minutes | Heat: 5 to 30 minutes, 15 minutes default;<br>Cold: 5 to 60 minutes, 15 minutes default;<br>Compression Only: 5 to 60 minutes, 15 minutes default | Regard to single treatment:<br>The single treatment time of Cryo-Thermo<br>Compression Device can be covered by primary<br>predicate Therm-X, which is also within the treatment<br>time range for cold or/and<br>compression therapy of the<br>secondary predicate Med4 Elite™.<br><br>For continuous use:<br>The continuous use of<br>Cryo-Thermo Compression<br>Device can be covered by |
| | Continuous use:<br>Cycle Length: Treatment<br>time: 10 min - 40min; Rest<br>time: 30 - 60min.<br>Cycle number: 1-6 cycles | Continuous use:<br>Cycle Length:<br>10 - 40 minutes active, 30 - 60<br>minutes rest<br>Continuous Treatment Cycle:<br>Available on Therm-X Home. | "Snooze" Function:<br>Available | |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| | | | | primary predicate Therm-X, Cryo-Thermo Compression Device provides same cycle length smaller cycle number and shorter total treatment time compared with the primary predicate Therm-X (based on information from the published IFU of Therm-X Home).<br><br>Compared with the secondary predicate Med4 Elite™ in cold therapy, Cryo-Thermo Compression Device provides shorter cycle length, same cycle number and shorter total treatment time (based on information from the published IFU of Med4 Elite™). |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| | | | | The safety and<br>effectiveness of Cryo-<br>Thermo's continuous use<br>have been demonstrated by<br>the skin temperature<br>testing.<br><br>Thus, there is no new<br>safety and effectiveness<br>issue. |
| | Physical Unit | | | |
| Dimensions | 13.7"L×5.75"W×11.02"H<br>(34.8×14.6×28.0cm) | 15"L×10.5"W×9"H<br>(38.1×26.67×22.86cm) | 32.5"L×24.75"W×43"H<br>(83×63×109cm) | The dimension of Cryo<br>Thermo Compression<br>Device is similar to the<br>primary predicate Therm X.<br><br>The cold therapy of the<br>secondary predicate Med4<br>Elite™ is conducted by<br>vapor compression with a |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| | | | | larger reservoir, thus Med4<br>Elite™'s dimension is<br>larger than the Cryo-<br>Thermo Compression<br>Device. |
| Weight | 17.64 lbs (8kg) when full of<br>coolant | 15 lbs. when full of coolant | 172 lbs (78 kg) | Cryo-Thermo Compression<br>Device is similar in weight<br>with the primary predicate<br>Therm-X.<br><br>The cold therapy of the<br>secondary predicate Med4<br>Elite™ is conducted by<br>vapor compression with a<br>larger reservoir, thus Med4<br>Elite™ is heavier than the<br>Cryo-Thermo Compression<br>Device. |
| Chilling<br>Mechanism | Thermoelectric | Thermoelectric | Vapor compression | The Cryo-Thermo<br>Compression Device has<br>the same chilling<br>mechanism with the |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| Heating<br>Mechanism | Thermoelectric | Thermoelectric | Resistance heaters | The Cryo-Thermo<br>Compression Device has<br>the same heating<br>mechanism with the<br>primary predicate Therm-X. |
| Reservoir Fluid<br>Capacity | 600mL | 650 mL | Heat reservoir: 1 gallon<br>(3.8 L)<br>Cold reservoir: 1 gallon<br>(3.8 L) | The reservoir fluid capacity<br>of the Cryo-Thermo<br>Compression Device is<br>similar to the primary<br>predicate Therm-X.<br><br>The secondary predicate<br>Med4 Elite™ has a larger<br>reservoir fluid capacity<br>since it is designed for<br>maximum two patients at a<br>treatment time, while Cryo-<br>Thermo Compression<br>Device and the primary<br>predicate Therm-X are for |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison |
| User Interface | Touch Screen | Touch Screen | Touch Screen | Same |
| Recommended<br>Coolant | 90% Distilled Water, 10%<br>Ethanol | 90% Distilled Water, 10%<br>Isopropyl Alcohol | Distilled Water | Cryo-Thermo Compression<br>Device recommends the<br>similar coolant to the<br>Therm-X.<br><br>Each device is able to attain<br>desired performance<br>requirements with its<br>recommended coolant. |
| Electrical | | | | |
| Line Voltage | 100-240 VAC | 100-240 VAC | 100-240 VAC | Same |
| Line Frequency | 60 Hz | 50/60 Hz | 50-60 Hz | Same |
| Electrical Safety<br>Standards | IEC 60601-1: 2005 + AMD<br>1:2012+AMD2:2020<br>Type B<br>IEC 60601-1-2 | ANSI/AAMI ES60601-<br>1:2005/(R)2012<br>CAN/CSA C22.2 No.60601-<br>1:2014<br>Type B<br>IEC 60601-1-2 | ANSI/AAMI ES60601-<br>1:2005/(R)2012<br>CAN/CSA C22.2 No.<br>60601-1:2014<br>Type B | The subject device was<br>tested per IEC 60601-<br>1:2005 + AMD<br>1:2012+AMD2:2020,<br>moreover, tests to cover the<br>US national differences<br>were supplemented as an<br>attachment to the IEC |
| Characteristics | Cryo-Thermo<br>Compression Device<br>(Subject Device) | Therm-X (K193550)<br>(Primary Predicate) | Med4 Elite™<br>(Secondary Predicate) | Comparison…