Massage Compression Boots

K201645 · Jkh USA, LLC · IRP · Sep 15, 2020 · Physical Medicine

Device Facts

• Record ID: K201645
• Device Name: Massage Compression Boots
• Applicant: Jkh USA, LLC
• Product Code: IRP · Physical Medicine
• Decision Date: Sep 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable, rechargeable pneumatic compression system; consists of control unit with air pump and inflatable garment with multiple air chambers. User operates via ON/OFF button, SET button, and LED interface. Device inflates chambers to predetermined pressure; internal pressure switch and software monitor levels; pump stops during rest period; sleeve deflates to ambient pressure; cycle repeats. Used in clinics, hospitals, athlete training, or home environments. Provides temporary relief of minor muscle aches and increased circulation via simulated kneading/stroking. Benefits patient through non-invasive, intermittent pneumatic compression.

Clinical Evidence

Bench testing only. Device validated for electrical safety (ANSI AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2). Software verification performed per FDA guidance. No clinical data provided.

Technological Characteristics

Materials: ABS plastic housing, nylon fabric sleeve, PVC air chambers. Principle: Intermittent pneumatic compression. Power: 5-12V DC (100-240 VAC input) and 3.7V rechargeable battery. Form factor: Portable control unit (165x83x55mm) connected to inflatable sleeves. Connectivity: Standalone. Sterilization: Clean, non-sterile. Software: Microprocessor-controlled pump system.

Indications for Use

Indicated for users needing temporary increase of blood circulation in treated areas and temporary relief of minor muscular aches and pains. Applicable to leg, arm/shoulder, and hip/waist. No specific age or gender restrictions noted.

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

• 2004-OC Massage System (K122112)
• Compression Therapy Device Model LGT-2200SP (K191862)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] 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,<br>Inc. | Guangzhou Longest Science<br>& Technology Co., Ltd. | N/A |
| Device Name/Model | Massage Compression Boots | 2004-OC Massage System | Compression Therapy<br>Device Model LGT-2200SP | N/A |
| Classification Name | Powered Inflatable Tube<br>Massager | Powered Inflatable Tube<br>Massager | Powered Inflatable Tube<br>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 | The Massage Compression<br>Boots are intended for the<br>temporary relief of minor muscle<br>aches and/or pains, and for the<br>temporary increase in circulation<br>to the treated areas. The device<br>can simulate kneading and<br>stroking of tissues by using an<br>inflatable garment. | The 2004-OC Massage<br>Systems are powered<br>inflatable tube massagers<br>intended to temporarily<br>relieve minor muscle aches<br>and/or pains, and to<br>temporarily increase<br>circulation to the treated areas.<br>The devices are intended for<br>home use by people who are<br>in good health. | Compression Therapy<br>Device LGT-2200SP is<br>intended for the temporary<br>relief of minor muscle aches<br>and pains and for the<br>temporary increase in<br>circulation to the treated<br>areas, it can simulate<br>kneading and stroking of<br>tissues by using an inflatable<br>garment. | Identical |
| Prescription or OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | 5-12V DC power supply (100-<br>240 VAC input) and 3.7V<br>rechargeable battery | 115 VAC, 50-60 Hz | AC 100-240V, 50/60Hz<br>Battery 11.1V, 6500mAh | Identical or similar.<br>The voltage<br>difference of power<br>supply used does not<br>change the product<br>performance or<br>parameters, which<br>does not raise any<br>new issue of the<br>safety or<br>effectiveness. |
| Internal rechargeable<br>batteries | Yes | No | Yes | Identical to the<br>Predicate/Reference<br>Device. The battery<br>used or not does not<br>raise any new issue |
| | | | of the safety or | |
| Compliance with<br>Voluntary Standards? | Yes | Yes | Yes | effectiveness. |
| Electrical Safety<br>Mechanical Safety<br>Chemical Safety Thermal<br>Safety Radiation Safety? | Yes | Yes | Yes | Identical |
| Functions and design | Simulate kneading and stroking<br>of tissue by use of inflatable<br>pressure cuffs | Simulate kneading and<br>stroking of tissue by use of<br>inflatable pressure cuffs | Simulate kneading and<br>stroking of tissue by use of<br>inflatable pressure cuffs | Identical |
| Target Population /<br>Intended Users | Users who need temporary<br>increase of blood circulation in<br>the treated area and temporary<br>relief of minor muscular aches<br>and pains | Users who need temporary<br>increase of blood circulation<br>in the treated area and<br>temporary relief of minor<br>muscular aches and pains | Users who need temporary<br>increase of blood circulation<br>in the treated area and<br>temporary relief of minor<br>muscular aches and pains | Identical |
| Intended use Environment | Clinics, hospital, athlete training,<br>and home environments | Clinics, hospital, athlete<br>training, and home<br>environments | Clinics, hospital, athlete<br>training, and home<br>environments | Identical |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical |
| Basis of operation | Using cyclic, intermittent,<br>pneumatic pressure application<br>(inflation followed by deflation) | Using cyclic, intermittent,<br>pneumatic pressure<br>application (inflation followed<br>by deflation) | Using cyclic, intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by deflation) | Identical |
| Anatomical Site /<br>Location of treatment<br>application | Leg, arm/shoulder, and hip/waist | Leg and arm/shoulder | Leg, arm, waist, hip, and<br>thigh | Identical |
| Software<br>Micro-processor<br>Control | Microprocessor | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump controlled by<br>microprocessor | Micro pump controlled by<br>microprocessor | Micro pump controlled by<br>microprocessor | Identical |
| Pressure Range | 0-120 mmHg | 30-80 mmHg | 30-150 mmHg | Identical or similar.<br>The subject device<br>has the compression<br>pressure within the<br>range of the primary<br>predicate device,<br>which does not raise<br>any new issue of the<br>safety or<br>effectiveness. |
| Cycle Time | 60-150 seconds | 90 seconds | N/A | Identical or similar.<br>The subject device<br>has the cycle time<br>cover that of the<br>primary predicate<br>device, which does<br>not raise any new<br>issue of the safety or<br>effectiveness. |
| System diagnostics | Audible and visual alarms<br>prompt recognition of system<br>faults | Visual alarms prompt<br>recognition of system faults | Audible and visual alarms<br>prompt recognition of<br>system faults | Identical |
| Air delivery from pump to<br>cuff bladder | Via flexible plastic tube(s)<br>connected directly to the air<br>bladder | Via flexible plastic tube(s)<br>connected directly to the air<br>bladder | Via flexible plastic tube(s)<br>connected directly to the air<br>bladder | 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<br>fabric sleeve | ABS housing and Nylon<br>fabric sleeve | ABS housing and Nylon<br>fabric 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.<br>The difference of<br>dimensions does not<br>raise any new issue<br>of safety or<br>effectiveness |
| Weight Approx. | 0.80kg | 3.6kg | 2kg | Identical or similar.<br>The difference of<br>weight does not raise<br>any new issue of<br>safety or<br>effectiveness |

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.