(90 days)
The Massage Compression Boots are intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.
The subject device is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue by use of an inflatable garment. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device, supplied clean and non-sterile, utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable sleeve of multiple air chambers. An ON/OFF button, a SET button, and a display of LEDs provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The sleeve component consists of multiple air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
The provided text is a 510(k) summary for the JKH USA, LLC Massage Compression Boots. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a standalone study proving the device meets specific performance criteria.
Therefore, many of the requested details about acceptance criteria, test set characteristics (sample size, provenance, expert consensus, adjudication), multi-reader multi-case studies, and ground truth for training/testing are not present in this type of regulatory submission. The FDA 510(k) pathway for Class II devices often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined performance metrics like sensitivity, specificity, and reader studies that are common for AI/ML-driven diagnostic devices.
However, I can extract the information that is available from the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table of acceptance criteria and reported device performance in the typical sense of quantitative metrics for a new, often AI/ML-driven, medical device's diagnostic or predictive capabilities. Instead, it compares the subject device to predicate devices on various technical specifications to demonstrate substantial equivalence.
Here's a summary of the comparisons, which serve as the "performance" relevant to a 510(k) for this type of device:
| Characteristic | Subject Device | Primary Predicate Device (K122112) | Predicate/Reference Device (K191862) | Equivalence Statement (Implicit "Acceptance Criteria") |
|---|---|---|---|---|
| Classification Name | Powered Inflatable Tube Massager | Powered Inflatable Tube Massager | Powered Inflatable Tube Massager | Identical |
| Regulation Class | 2 | 2 | 2 | Identical |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| Principal of Operation | Pneumatic compression | Pneumatic compression | Pneumatic compression | Identical |
| Intended Use | Temp. relief minor muscle aches/pains, temp. increase circulation, simulate kneading/stroking | Temp. relief minor muscle aches/pains, temp. increase circulation, for home use by healthy people | Temp. relief minor muscle aches/pains, temp. increase circulation, simulate kneading/stroking | Identical |
| Prescription or OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | 5-12V DC (100-240 VAC input) and 3.7V rechargeable battery | 115 VAC, 50-60 Hz | AC 100-240V, 50/60Hz, Battery 11.1V, 6500mAh | Identical or similar. Voltage difference does not change product performance or parameters, raising no new safety/effectiveness issues. |
| Internal rechargeable batteries | Yes | No | Yes | Identical to Predicate/Reference Device. Battery use does not raise new safety/effectiveness issues. |
| Compliance with Voluntary Standards? | Yes | Yes | Yes | Identical |
| Electrical Safety | Yes | Yes | Yes | Identical |
| Mechanical Safety | Yes | Yes | Yes | Identical |
| Chemical Safety | Yes | Yes | Yes | Identical |
| Thermal Safety | Yes | Yes | Yes | Identical |
| Radiation Safety? | Yes | Yes | Yes | Identical |
| Functions and design | Simulate kneading and stroking of tissue by inflatable pressure cuffs | Simulate kneading and stroking of tissue by inflatable pressure cuffs | Simulate kneading and stroking of tissue by inflatable pressure cuffs | Identical |
| Target Population / Intended Users | Users needing temp. increased blood circulation and temp. relief of minor muscle aches/pains | Users needing temp. increased blood circulation and temp. relief of minor muscle aches/pains | Users needing temp. increased blood circulation and temp. relief of minor muscle aches/pains | Identical |
| Intended use Environment | Clinics, hospital, athlete training, home | Clinics, hospital, athlete training, home | Clinics, hospital, athlete training, home | Identical |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical |
| Basis of operation | Cyclic, intermittent, pneumatic pressure application | Cyclic, intermittent, pneumatic pressure application | Cyclic, intermittent, pneumatic pressure application | Identical |
| Anatomical Site / Location of treatment application | Leg, arm/shoulder, hip/waist | Leg and arm/shoulder | Leg, arm, waist, hip, and thigh | Identical. The subject device covers the anatomical sites of the predicate devices. |
| Software Micro-processor Control | Microprocessor | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Micro pump controlled by microprocessor | Identical |
| Pressure Range | 0-120 mmHg | 30-80 mmHg | 30-150 mmHg | Identical or similar. Subject device's range is within/overlaps with predicate devices without raising new safety/effectiveness issues. |
| Cycle Time | 60-150 seconds | 90 seconds | N/A (not specified for one predicate) | Identical or similar. Subject device's range covers primary predicate device's cycle time, raising no new safety/effectiveness issues. |
| System diagnostics | Audible and visual alarms | Visual alarms | Audible and visual alarms | Identical (to one predicate). |
| Air delivery | Via flexible plastic tube(s) | Via flexible plastic tube(s) | Via flexible plastic tube(s) | Identical |
| Sterility | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Identical |
| Cuff usage | Single Patient Use | Single Patient Use | Single Patient Use | Identical |
| Material Used | ABS housing and Nylon fabric sleeve | ABS housing and Nylon fabric sleeve | ABS housing and Nylon fabric sleeve | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Identical. Stated that skin contact components/materials are identical in formulation, suppliers, processing, geometry, and no other chemicals added, so no biocompatibility issue. |
| Patient Contact | Non-conductive appliances | Non-conductive appliances | Non-conductive appliances | Identical |
| Dimensions | 165x83x55mm | 305x203x140mm | 270x148x129mm | Identical or similar. Difference in dimensions does not raise new safety or effectiveness issues. |
| Weight Approx. | 0.80kg | 3.6kg | 2kg | Identical or similar. Difference in weight does not raise new safety or effectiveness issues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical "test set" in the context of an AI/ML algorithm's performance evaluation. The substantial equivalence argument is based on non-clinical tests (bench tests for physical, electrical, and performance requirements, and software verification) and comparison to predicate devices, not patient data from a test set. Therefore, sample size and data provenance are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, there was no clinical "test set" requiring expert-established ground truth for performance evaluation of a diagnostic or predictive algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This type of study is not mentioned or required for this 510(k) submission for a non-diagnostic pneumatic compression device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML diagnostic algorithm. The device itself is a "Powered Inflatable Tube Massager." Its "performance" is demonstrated by meeting general safety standards and comparison of its physical and functional characteristics to legally marketed predicate devices, not by a standalone performance study in the way an AI algorithm would be evaluated. The software verification was performed according to FDA guidance, but this refers to the robustness and functionality of the device's control software, not a standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/ML diagnostic or predictive model. The "ground truth" for this device's performance relies on its adherence to safety standards (e.g., electrical, mechanical) and the functional equivalence (e.g., pressure range, cycle time, intended use) to predicate devices already deemed safe and effective.
8. The sample size for the training set
Not applicable. There is no mention of an AI/ML training set as this is not an AI/ML device in the context of what would typically require such a set (e.g., for image analysis or disease prediction).
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2020
JKH USA, LLC Bill Dai Manager 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K201645
Trade/Device Name: Massage Compression Boots Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: June 14, 2020 Received: June 17, 2020
Dear Dr. 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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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,
Amber Ballard, PhD Assistant 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
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Indications for Use
510(k) Number (if known) K201645
Device Name Massage Compression Boots
Indications for Use (Describe)
The Massage Compression Boots are intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Submitter's Information
Submitter: JKH USA, LLC Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 Contact Person: Dr. Bill Quanqin Dai Tel: 909-929-9896 Email: Bill(@jkhUSA.com Date of Preparation: 06/14/2020
2. Subject Device
Trade/Device Name: Massage Compression Boots Common Name: Massager, Powered Inflatable Tube Regulation Medical Specialty: Physical Medicine Review Panel: Physical Medicine Product Code: IRP Regulation Number: 21 CFR 890.5650 Device Class: II Use: Over-The-Counter (OTC)
3. Predicate device
Primary Predicate Device: 2004-OC Massage System 510(k) Number: K122112 Clearance Date: April 9, 2013 Submitter: Bio Compression Systems, Inc.
Predicate Device: Compression Therapy Device Model LGT-2200SP 510(k) Number: K191862 Clearance Date: October 29, 2019 Submitter: Guangzhou Longest Science & Technology Co., Ltd.
4. Description of Subject Device
The subject device is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue by use of an inflatable garment. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
The device, supplied clean and non-sterile, utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable sleeve of multiple air chambers. An ON/OFF button, a SET button, and a display of LEDs provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The sleeve component consists of multiple air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A sleeve containing the air chambers is connected to the control unit. And the control unit then inflates the sleeve to the predetermined or adjusted pressure. The sleeve pressure is monitored by an internal pressure switch and system software. Once the sleeve pressure of the air chambers reaches the proper level, the pump is
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turned off for a rest period, and the sleeve deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation repeats until the unit is turned off.
5. Indications for Use
The Massage Compression Boots are intended for the temporary relief of minor muscle aches and/or pains, and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.
6. Summary of Substantial Equivalence
The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| Subject Device | Primary Predicate Device | Predicate/Reference Device | Equivalence | |
|---|---|---|---|---|
| 510(k) Number | N/A | K122112 | K191862 | N/A |
| Submitter | JKH USA, LLC | Bio Compression Systems,Inc. | Guangzhou Longest Science& Technology Co., Ltd. | N/A |
| Device Name/Model | Massage Compression Boots | 2004-OC Massage System | Compression TherapyDevice Model LGT-2200SP | N/A |
| Classification Name | Powered Inflatable TubeMassager | Powered Inflatable TubeMassager | Powered Inflatable TubeMassager | Identical |
| Regulation Class | 2 | 2 | 2 | Identical |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| Principal of Operation | Pneumatic compression | Pneumatic compression | Pneumatic compression | Identical |
| Intended Use | The Massage CompressionBoots are intended for thetemporary relief of minor muscleaches and/or pains, and for thetemporary increase in circulationto the treated areas. The devicecan simulate kneading andstroking of tissues by using aninflatable garment. | The 2004-OC MassageSystems are poweredinflatable tube massagersintended to temporarilyrelieve minor muscle achesand/or pains, and totemporarily increasecirculation to the treated areas.The devices are intended forhome use by people who arein good health. | Compression TherapyDevice LGT-2200SP isintended for the temporaryrelief of minor muscle achesand pains and for thetemporary increase incirculation to the treatedareas, it can simulatekneading and stroking oftissues by using an inflatablegarment. | Identical |
| Prescription or OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | 5-12V DC power supply (100-240 VAC input) and 3.7Vrechargeable battery | 115 VAC, 50-60 Hz | AC 100-240V, 50/60HzBattery 11.1V, 6500mAh | Identical or similar.The voltagedifference of powersupply used does notchange the productperformance orparameters, whichdoes not raise anynew issue of thesafety oreffectiveness. |
| Internal rechargeablebatteries | Yes | No | Yes | Identical to thePredicate/ReferenceDevice. The batteryused or not does notraise any new issue |
| of the safety or | ||||
| Compliance withVoluntary Standards? | Yes | Yes | Yes | effectiveness. |
| Electrical SafetyMechanical SafetyChemical Safety ThermalSafety Radiation Safety? | Yes | Yes | Yes | Identical |
| Functions and design | Simulate kneading and strokingof tissue by use of inflatablepressure cuffs | Simulate kneading andstroking of tissue by use ofinflatable pressure cuffs | Simulate kneading andstroking of tissue by use ofinflatable pressure cuffs | Identical |
| Target Population /Intended Users | Users who need temporaryincrease of blood circulation inthe treated area and temporaryrelief of minor muscular achesand pains | Users who need temporaryincrease of blood circulationin the treated area andtemporary relief of minormuscular aches and pains | Users who need temporaryincrease of blood circulationin the treated area andtemporary relief of minormuscular aches and pains | Identical |
| Intended use Environment | Clinics, hospital, athlete training,and home environments | Clinics, hospital, athletetraining, and homeenvironments | Clinics, hospital, athletetraining, and homeenvironments | Identical |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical |
| Basis of operation | Using cyclic, intermittent,pneumatic pressure application(inflation followed by deflation) | Using cyclic, intermittent,pneumatic pressureapplication (inflation followedby deflation) | Using cyclic, intermittent,pneumatic pressureapplication (inflationfollowed by deflation) | Identical |
| Anatomical Site /Location of treatmentapplication | Leg, arm/shoulder, and hip/waist | Leg and arm/shoulder | Leg, arm, waist, hip, andthigh | Identical |
| SoftwareMicro-processorControl | Microprocessor | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled bymicroprocessor | Micro pump controlled bymicroprocessor | Micro pump controlled bymicroprocessor | Identical |
| Pressure Range | 0-120 mmHg | 30-80 mmHg | 30-150 mmHg | Identical or similar.The subject devicehas the compressionpressure within therange of the primarypredicate device,which does not raiseany new issue of thesafety oreffectiveness. |
| Cycle Time | 60-150 seconds | 90 seconds | N/A | Identical or similar.The subject devicehas the cycle timecover that of theprimary predicatedevice, which doesnot raise any newissue of the safety oreffectiveness. |
| System diagnostics | Audible and visual alarmsprompt recognition of systemfaults | Visual alarms promptrecognition of system faults | Audible and visual alarmsprompt recognition ofsystem faults | Identical |
| Air delivery from pump tocuff bladder | Via flexible plastic tube(s)connected directly to the airbladder | Via flexible plastic tube(s)connected directly to the airbladder | Via flexible plastic tube(s)connected directly to the airbladder | Identical |
| Sterility | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Identical |
| Cuff usage | Single Patient Use | Single Patient Use | Single Patient Use | Identical |
| Material Used | ABS housing and Nylon fabricfabric sleeve | ABS housing and Nylonfabric sleeve | ABS housing and Nylonfabric sleeve | Identical |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Identical |
| Patient Contact | Non-conductive appliances | Non-conductive appliances | Non-conductive appliances | Identical |
| Dimensions | 165x83x55mm | 305x203x140mm | 270x148x129mm | Identical of similar.The difference ofdimensions does notraise any new issueof safety oreffectiveness |
| Weight Approx. | 0.80kg | 3.6kg | 2kg | Identical or similar.The difference ofweight does not raiseany new issue ofsafety oreffectiveness |
Table 1. Comparison between the subject device and the predicate device
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7. Substantial Equivalence
As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device. And the differences discussed between the subject device and the predicate device do not raise any new issues of safety or effectiveness.
The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver pressurized air to chambers that are attached to the user's body area. Each cycle consists of air inflation of chambers, followed by a rest period during which the chambers deflate and the relax without any compression.
Identical to the predicate device the subject device has multiple and visual safety alarms built into the system. including the low pressure alarm and low battery alarm. In addition, the sleeve is comprised of multiple bladder PVC chambers encased in a covering of soft and non-latex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. The microprocessor and pump units are powered by internal rechargeable batteries, and can be connected to the main AC power line (through the battery charger / AC adaptor) while in use, allowing uninterrupted prolonged service.
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.
As demonstrated, 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.
8. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
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- (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".
In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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).