(21 days)
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.
The provided text is a 510(k) Summary for a medical device called "Cold Compression". This document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a study of its performance in a clinical or analytical setting.
Therefore, the input document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that "Clinical testing was not needed in support of this 510(k) application." (Section 8) and focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests for electrical safety and electromagnetic compatibility.
Instead, the document provides:
Non-Clinical Tests Performed:
- Tests: Non-clinical tests were performed to validate the design and assure conformance with voluntary design standards related to medical device electrical safety and electromagnetic compatibility.
- Standards:
- IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
Comparison Table (Table 1):
This table compares the subject device ("Cold Compression") with two predicate devices (K223541 and K183702) across various technical characteristics and specifications to establish substantial equivalence. While it doesn't present "acceptance criteria" in the traditional sense of a performance study, it details the characteristics where the device's performance parameters are deemed acceptable due to their similarity to a legally marketed device.
| Characteristic | Subject Device Performance | Predicate Device Performance (relevant to equivalence) | Equivalence Conclusion |
|---|---|---|---|
| Product Codes | IRP and ILO | Primary Predicate: IRP, ILO, and JOW Predicate: IRP and ILO | The subject device has the product codes covered by the primary predicate device, and also identical to the predicate device. |
| Indications for Use | To treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. Used by or on order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings. | Primary Predicate: Combines cold, heat, contrast, and compression therapy. Intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain. Also provides DVT therapy. Used by or on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. Predicate: To treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. Used by or on order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The subject device has the Indications for Use covered by the primary predicate device, and also substantially equivalent to the predicate device. |
| Intended Users | Health Care Professionals and lay users (under prescription), with adult use; children and elderly under direct medical professional supervision. | Primary Predicate and Predicate: Identical. | Identical |
| Prescription or OTC | Prescription | Primary Predicate and Predicate: Prescription | Identical |
| Power Source(s) | 100-240 VAC, 50/60 Hz | Primary Predicate and Predicate: 100-240 VAC, 50/60 Hz | Identical |
| Compliance with Voluntary Standards | Yes | Primary Predicate and Predicate: Yes | Identical |
| Safety (Electrical, Mechanical, Chemical, Thermal, Radiation) | Yes | Primary Predicate and Predicate: Yes | Identical |
| Therapy | Cold and Compression. Work together or independently. | Primary Predicate: Cold, Heat, Contrast and Compression. Predicate: Cold and Compression. Work together or independently. | The subject device has the therapy covered by the primary predicate device, and also identical to the predicate device. The difference between the subject device and the primary predicate device is the former does not provide heat or contrast therapy. |
| Cold Therapy Temperature | 45°F - 55°F | Primary Predicate: Default: 50°F; Custom: 41°F-55°F Predicate: 45°F - 60°F | Equivalent Note 1: The temperature range of cold therapy for the subject device is within that of the primary predicate device and the predicate device. Adjustable by healthcare professionals. Insignificant difference. |
| Heat Therapy | Not Available | Primary Predicate: Default: 105°F; Custom: 105°F-109°F Predicate: Not Available | Identical to the predicate device. The difference from the primary predicate device (lack of heat/contrast therapy) is noted but does not raise new safety/effectiveness issues for this specific device. |
| Compression Setting | 0 - 60 mmHg | Primary Predicate: Alternate mode: 15 -75 mm Hg; Continuous mode: 15 -75 mm Hg Predicate: Low (0-25 mmHg), Regular (0-50 mmHg) | Equivalent Note 2: The pressure range for the subject device is within that of the primary predicate device and slightly higher than the predicate device. Adjustable by healthcare professionals. Insignificant difference. |
| Reservoir Fluid Capacity | 620 mL | Primary Predicate: 350 mL Predicate: Not Available | Different, but it will not raise any new issue of safety or effectiveness. |
| Recommended Coolant | Tap Water | Primary Predicate: 90% Distilled Water, 10% Isopropyl Alcohol Predicate: Tap Water | Identical to the predicate device. The difference from the primary predicate is noted but does not raise new safety/effectiveness issues. |
| Water Cooling Source | Ice | Primary Predicate: Vapor compression Predicate: Ice | Identical to the predicate device. The difference from the primary predicate is noted but does not raise new safety/effectiveness issues. |
| User Interface | Keypad with indicator lights or LCD screen | Primary Predicate: Touch Screen Predicate: Keypad with indicator lights | Different from the primary predicate device and similar to the predicate device. It will not raise any new issue of safety or effectiveness. |
| Dimensions | L235xW235xH280mm | Primary Predicate: L295xW285xH295 mm Predicate: Not Available | Different. The difference of dimensions does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. |
| Weight Approx. | 2.4kg | Primary Predicate: 8.2kg Predicate: Not Available | Different. The difference of weight does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. |
| Types of Garments | Various anatomical thermal garments for: Back, Elbow/Universal, Shoulder, Knee, Ankle, Hip. | Primary Predicate: Various anatomical thermal garments for: Back, Elbow, Shoulder, Knee, Ankle, Hip. DVT Garments: Calf and Foot. Predicate: Various anatomical thermal garments for: Back, Universal, Shoulder, Knee, Foot/Ankle, Hip. | The subject device has the garments covered by the primary predicate device, and also substantially equivalent to the predicate device. |
| Biocompatibility of Patient Contacting Material | Biocompatible | Primary Predicate and Predicate: Biocompatible | Identical |
| Sterile/Non-Sterile | Non-sterile | Primary Predicate and Predicate: Non-sterile | Identical |
| Cleaning Disinfection Validation of Labeling | Yes | Primary Predicate and Predicate: Yes | Identical |
| Operational and Environmental Conditions | Normal working ambient temperature: 5 | Primary Predicate: Normal working ambient temperature: 16 | Identical to the predicate device. The difference between the subject device and the primary predicate device is the former does not provide heat or contrast therapy. (Note: The operational and environmental conditions are listed as identical to the second predicate device, not the primary one, despite the "difference between the subject device and the primary predicate device" wording). |
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2024
JKH Health Co., Ltd. % Bill Quanqin Dai Managing Member JKH USA LLC 14271 Jeffrey Road #246 Irvine, CA 92620
Re: K240986
Trade/Device Name: Cold Compression Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP. ILO Dated: February 22, 2024 Received: April 10, 2024
Dear Bill Dai:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Cold Compression
Indications for Use (Describe)
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, 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
1. Submitter's Information
JKH Health Co., Ltd. Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xinqiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Tel: +86-755-27926589 Fax: +86-755-27926585 E-mail: sales@JKHhealth.com Date of Preparation: 4/09/2024
2. Subject Device
Trade/Device Name: Cold Compression Common Name: Powered Inflatable Tube Massager; Hot or Cold, Water Circulating Pack Regulation Medical Specialty: Physical Medicine Review Panel: Physical Medicine Product Code: IRP, ILO Regulation Number: 21 CFR 890.5650, 21 CFR 890.5720 Device Class: II Use: Prescription
Predicate device
Primary Predicate Device: Cold/Hot Compression 510(k) Number: K223541 Clearance Date: October 27, 2023 Submitter: JKH Health Co., Ltd.
Predicate Device: Polar Care Wave 510(k) Number: K183702 Clearance Date: March 1, 2019 Submitter: Breg Inc.
3. Description of Subject Device
The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to
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connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.
4. Indications for Use
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
5. Summary of Substantial Equivalence
The comparison Table 1 summarizes the detailed comparison between the subject device and the predicate device, indicating the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate device.
| Subject Device | Primary Predicate Device | Predicate Device | Equivalence | |
|---|---|---|---|---|
| 510(k) Number | K240986 | K223541 | K183702 | N/A |
| Submitter | JKH Health Co., Ltd. | JKH Health Co., Ltd. | Breg Inc. | N/A |
| Device Name/Model | Cold Compression | Cold/Hot Compression | Polar Care Wave | N/A |
| Product CodeRegulation Number | IRP and ILO | IRP, ILO, and JOW | IRP and ILO | The subject device hasthe product codescovered by the primarypredicate device, andalso identical to thepredicate device. |
| Indications for Use | Cold Compression is intendedto treat post-surgical and acuteinjuries to reduce edema,swelling, and pain for whichcold and compression areindicated.Cold Compression is intendedto be used by or on the order oflicensed healthcareprofessionals in rehabilitationfacilities/hospitals, outpatientclinics, athletic trainingsettings, and home settings. | Cold/Hot Compressioncombines cold, heat, contrast,and compression therapy. It isintended to treat post-surgicaland acute injuries to reduceedema, swelling, and pain forwhich cold and compressionare indicated. It is intended totreat post traumatic andpostsurgical medical and/orsurgical conditions for whichlocalized thermal therapy (hotor cold) are indicated.Cold/Hot Compression alsoprovide DVT therapy. It isintended to reduce the risk ofthe formation of deep venousthrombosis (DVT) by aidingblood flow back to the heart vialower extremity limbcompression.Cold/Hot Compression isintended to be used by, or onthe order of, licensed healthcare professionals inrehabilitation facilities,outpatient clinics, athletictraining settings, and homesettings. | The Polar Care Wave System isintended to treat post-surgicaland acute injuries to reduceedema, swelling, and painwhere cold and compressionare indicated. It is intended tobe used by or on the order oflicensed healthcareprofessionals in hospitals,outpatient clinics, athletictraining settings, or homesettings. | The subject device hasthe Indications for Usecovered by the primarypredicate device, andalso substantiallyequivalent to thepredicate device. |
| Intended Users | Health Care Professionals and | Health Care Professionals and | Health Care Professionals and | Identical |
| Age range of the targetpopulation | lay users (under prescription)Adult; children and the elderlyshould only use the productunder direct supervision of amedical professional | lay users (under prescription)Adult; children and the elderlyshould only use the productunder direct supervision of amedical professional | lay users (under prescription)Adult; children and the elderlyshould only use the productunder direct supervision of amedical professional | Identical |
| Prescription or OTC | Prescription | Prescription | Prescription | Identical |
| Power Source(s) | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Identical |
| Compliance withVoluntary Standards? | Yes | Yes | Yes | Identical |
| Electrical SafetyMechanical SafetyChemical SafetyThermal SafetyRadiation Safety? | Yes | Yes | Yes | Identical |
| Therapy | Cold and CompressionWork together or independently | Cold, Heat, Contrast andCompression | Cold and CompressionWork together or independently | The subject device hasthe therapy covered bythe primary predicatedevice, and alsoidentical to thepredicate device. Thedifference between thesubject device and theprimary predicatedevice is the formerdoes not provide heat orcontrast therapy. |
| Cold Therapy | 45°F - 55°F | Default: 50°FCustom: 41°F-55°FDefault, continuous: 50°FCustom, continuous: 41°F-50°F | 45°F - 60°F | Equivalent Note 1 |
| Heat Therapy | Not Available | Default: 105°FCustom: 105°F-109°FDefault, continuous: 105°FCustom, continuous: 105°F-109°F | Not Available | Identical to thepredicate device. Thedifference between thesubject device and theprimary predicatedevice is the formerdoes not provide heat orcontrast therapy. |
| Compression Setting | 0 - 60 mmHg | Compression Therapy Alternatemode: 15 -75 mm HgCompression Therapy Continuousmode: 15 -75 mm Hg | Available in two levelsLow (0-25 mmHg)Regular (0-50 mmHg) | Equivalent Note 2 |
| Reservoir FluidCapacity | 620 mL | 350 mL | Not Available | Different, but it will notraise any new issue ofthe safety oreffectiveness. |
| RecommendedCoolant | Tap Water | 90% Distilled Water,10% Isopropyl Alcohol | Tap Water | Identical to thepredicate device. Thedifference between thesubject device and theprimary predicatedevice is the formerdoes not provide heat orcontrast therapy. |
| Water Cooling Source | Ice | Vapor compression | Ice | Identical to thepredicate device. Thedifference between thesubject device and theprimary predicatedevice is the formerdoes not provide heat orcontrast therapy. |
| User Interface | Keypad with indicator lights or | Touch Screen | Keypad with indicator lights | Different from the |
| LCD screen | primary predicate | |||
| Dimensions | L235xW235xH280mm | L295xW285xH295 mm | Not Available | device and similar tothe predicate device. Itwill not raise any newissue of the safety oreffectiveness.Different. Thedifference ofdimensions does notchange the productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness. |
| Weight Approx. | 2.4kg | 8.2kg | Not Available | Different. Thedifference of weightdoes not change theproduct performance orparameters, which willnot raise any new issueof the safety oreffectiveness. |
| Types of Garments | Various anatomical thermalgarments for: Back,Elbow/Universal,Shoulder, Knee, Ankle, Hip. | Various anatomical thermalgarments for: Back, Elbow,Shoulder, Knee, Ankle, Hip.DVT Garments: Calf and Foot | Various anatomical thermalgarments for: Back, Universal,Shoulder, Knee, Foot/Ankle,Hip. | The subject device hasthe garments coveredby the primarypredicate device, andalso substantiallyequivalent to thepredicate device. |
| Biocompatibility ofPatient ContactingMaterial | Biocompatible | Biocompatible | Biocompatible | Identical |
| Sterile/Non-Sterile | Non-sterile | Non-sterile | Non-sterile | Identical |
| Cleaning DisinfectionValidation of Labeling | Yes | Yes | Yes | Identical |
| Operational andEnvironmentalConditions | - Normal working ambienttemperature: 5 | - Normal working ambienttemperature: 16 | - Normal working ambienttemperature: 5 | Identical to thepredicate device. Thedifference between thesubject device and theprimary predicatedevice is the formerdoes not provide heat orcontrast therapy. |
Table 1. Comparison between the subject device and the predicate device
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Equivalent Note 1: The temperature range of cold therapy for the subject device is within that of the primary predicate device and the predicate device. In addition, the temperature of cold therapy for both the subject and predicate devices can be adjusted and determined by the health care professionals or on the order of health care professionals. Therefore, the temperature difference of cold therapy between the subject and predicate devices is insignificant. Such a difference between the subject and predicate devices does not raise any new issues of safety or effectiveness.
Equivalent Note 2: The pressure range of compression therapy for the subject device is within that of the primary predicate device, and is slightly higher than that of the predicate device. In addition, the pressure level can be adjusted and determined for both the subject device and the predicate device by the health care professionals or on the order of health care professionals. Therefore, the difference of compression pressure between the subject and predicate devices is insignificant. Such a difference between the subject device and the predicate device does not raise any new issues of safety or effectiveness.
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6. Substantial Equivalence
As discussed above and shown in the above table, the subject device in this submission has the identical or similar performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness. Also, the differences between the subject and predicate devices do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness to the predicate device.
Identical to the predicate device, the subject device has multiple and visual safety alarms built into the system, including low pressure alarm and low battery alarm. The microprocessor and pump units can be powered by the internal rechargeable battery, or can be connected to the main AC power line (through the battery charger / AC adaptor). The skin contact components and materials of the subject device are identical to those of the predicate device in formulation, suppliers, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Therefore, there is no issue or concern of biocompatibility.
7. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
8. Clinical Testing
Clinical testing was not needed in support of this 510(k) application.
9. Conclusion
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.
§ 890.5650 Powered inflatable tube massager.
(a)
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.(b)
Classification. Class II (performance standards).