A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.

Device Description

This product is an Intermittent Pneumatic Compression system to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

AI/ML Overview

The provided document is a 510(k) summary for the LX9max device, which is a powered inflatable tube massager. The document aims to demonstrate that the LX9max is substantially equivalent to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and a reference device (Rapid Reboot REGEN+).

Here's an analysis of the acceptance criteria and the study as requested:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics or thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has similar indications for use, technological characteristics, and safety and effectiveness profiles as the cleared predicate.

The table provided (Table 1: Comparison of Proposed Device to Predicate / Reference Devices) compares various characteristics:

Characteristic	Proposed Device (LX9max)	Predicate Device (Rapid Reboot Compression Therapy System)	Reference Device (Rapid Reboot REGEN+)
Indications For Use	A device intended to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.	Same as proposed device, with added "simulates kneading and stroking of tissues by using an inflatable garment."	Same as predicate device.
Intended Use environment	Home environments (Indoor environments)	Clinics, hospital, athlete training, and home environments.	Clinics, hospital, athlete training, and home environments.
OTC or Rx only	OTC	OTC	OTC
Accessories	Leg sleeves, Arm sleeve, Center body sleeve	Leg sleeve, Arm sleeve, Hip sleeve	Leg sleeve, Arm sleeve, Hip sleeve
Power Source	100-127V~, 50/60Hz	110 V, 60Hz	110 V, 60Hz
Time	5-90 min	10,20,30 min	1-179 minutes
Pressure	10-180mmHg ± 20 mmHg	0-200 mmHg	0-200 mmHg
Number of chamber	4	4	4

The "reported device performance" for the LX9max is implicitly that it meets the safety and effectiveness standards of the predicate devices because its technological characteristics are similar, and any differences (pressure range, time range, sleeve type) do not raise new questions of safety or effectiveness. The justification for these minor differences is presented on page 7.

The document also states that the LX9max complies with several voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment (listed on page 8). These standards serve as technical acceptance criteria for safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical Testing was not required to demonstrate the substantial equivalence of the LX9max to its predicate / reference device." (page 8).

Therefore, there

was no clinical test set used for this submission to prove substantial equivalence.
no observational data provenance (country, retrospective/prospective) is applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical testing was performed for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing was performed for substantial equivalence.

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

Not applicable. This device is a physical therapy device (massager), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical ground truth was established as no clinical testing was performed. The basis for substantial equivalence relies on comparison of technical characteristics and compliance with safety standards.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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July 2, 2021

Daesung Maref CO., LTD. Su Hyeon So Assistant Researcher 298-24, Gongdan-Ro Gunpo-Si. Gyeonggido 15809 South Korea

Re: K203498

Trade/Device Name: LX9max Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 14, 2021 Received: May 19, 2021

Dear Su Hyeon So:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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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 (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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203498

Device Name LX9max

Indications for Use (Describe)

A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.

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

K203498

1. Data Prepared [21. CFR 807.92(a)(a)]

June 30, 2021

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Manufacturer :
- DAESUNG MAREF CO.,LTD
Address :
- 298-24, Gongdan-ro Gunpo-si, Gyeonggido Republic of Korea
Contact Name : Su Hyeon, So
Telephone No. :
- 82-31-459-7211
Fax No. :

82-31-459-7215

Email Address : rndra@dsmaref.com
Registration No. :
- 3004116008

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade /Device Name :
- LX9max
Regulation Number :
- 21 CFR 890.5650
Regulation Name :
- Massager, Powered Inflatable Tube
Regulation Class. :
- II
Product Code :
- IRP

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4. Identification of Predicate/Reference Device(s) [21 CFR 807.92(a)(3)]

Predicate Device

510(k) Number : K182668 • Applicant : Rapid Reboot Recovery Products, LLC • Trade/Device Name : Rapid Reboot Compression Therapy System • Regulation Number : 21 CFR 890.5650 • Regulation Name : Massager, Powered Inflatable Tube · Regulation Class : II
Product Code :

IRP

Predicate device has not been subject to a design-related recall.

Reference Device

510(k) Number : K203552
Applicant : Rapid Reboot Recovery Products, LLC
Trade/Device Name : Rapid Reboot REGEN+
Regulation Number : 21 CFR 890.5650
Regulation Name :
- Massager, Powered Inflatable Tube
Regulation Class :
- II
Product Code : IRP

Reference device has not been subject to a design-related recall.

5. Description of the Device [21 CFR 807.92(a)(4)]

The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

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6. Indications For Use [21 CFR 807(a)(5)]

A device intended to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.

7. Determination of Substantial Equivalence

Summary of technological characteristics of the device compared to the predicate device. [21CFR 807.92(a)(6)]

The LX9max is substantially equivalent to legally marketed predicate device (Rapid Reboot Compression Therapy System) and Reference Devices(Rapid Reboot REGEN+) with respect to indications for use and technology characteristics. The table below presents comparisons for device :

	Proposed Device	Predicate Device	Reference Device
Model Name	LX9max	Rapid Reboot CompressionTherapy System	Rapid Reboot REGEN+
510(k) Number	K203498	K182668	K203552
Manufacturer	DAESUNG MAREF CO.,LTD.	Rapid Reboot RecoveryProducts, LLC	Rapid Reboot RecoveryProducts, LLC
Product Code	IRP	IRP	IRP
Device Class	II	II	II
RegulationNumber	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650
Regulation name	Massager, Powered InflatableTube	Massager, Powered InflatableTube	Massager, Powered InflatableTube
	Proposed Device	Predicate Device	Reference Device
Indications ForUse	A device intended totemporarily relieve minormuscle aches and pains andfor temporary increase incirculation to the treatedareas in people who are ingood health.	The Rapid RebootCompression Therapy Systemis intended for the temporaryrelief of minor muscle achesand pains and for thetemporary increase incirculation to the treatedareas in people who are ingood health. The RapidReboot Compression TherapySystem simulates kneadingand stroking of tissues byusing an inflatable garment.	This device is intended forthe temporary relief of minormuscle aches and pains andfor the temporary increase incirculation to the treatedareas in people who are ingood health. The RapidReboot Compression TherapySystem simulates kneadingand stroking of tissues byusing an inflatable garment.
Intended Useenvironment	Home environments (Indoorenvironments)	Clinics, hospital, athletetraining, and homeenvironments.	Clinics, hospital, athletetraining, and homeenvironments.
OTC or Rx only	OTC	OTC	OTC
Accessories	Leg sleeves, Arm sleeve,Center body sleeve	Leg sleeve, Arm sleeve, Hipsleeve	Leg sleeve, Arm sleeve, Hipsleeve
Specifications
Power Source	100-127V~, 50/60Hz	110 V, 60Hz	110 V, 60Hz
Time	5-90 min	10,20,30 min	1-179 minutes
Pressure	10-180mmHg ± 20 mmHg	0-200 mmHg	0-200 mmHg
Number ofchamber	4	4	4

[Table 1. Comparison of Proposed Device to Predicate / Reference Devices]

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The table also provides rationale for a little difference in support of substantial equivalence to the Predicate / Reference Devices.

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Justification to Support Substantial Equivalence

Proposed device (LX9max) and Predicate device (Rapid Reboot Compression Therapy System) can be considered to be almost equivalent except for pressure range, time range, and sleeve type.

The pressure range of the proposed device are included within pressure range of the predicate device.

About difference of time range, Since the principle of action is the pressure of the proposed device is lower than that of the predicate device, the difference in time range does not have a serious effect on safety and effectiveness. And because the operating principle is similar, even if the sleeves are different, they operate in the same way, and the pressure is also lower than that of the predicate device & Reference device.

The reference device is from the same manufacturer as the predicate device (K182668), and has been cleared by 510(k) as a substantially equivalent device.

The operating time of the reference device is 1-179 minutes, which is larger than the operating time of the proposed device. Therefore, the differences in technological characteristics do not raise different questions of safety and effectiveness.

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Non-Clinical Test Summary

The LX9max complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability.

The following data were provided in support of the substantial equivalence determination.

1. Electrical Safety, Electromagnetic Compatibility and Performance The LX9max complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601 60601-1-2:2014, Medical Electrical Equipment Part 1 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601 60601-1-11:2015, Medical Electrical Equipment Part 1 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
1. Biocompatibility
- Biocompatibility of the sleeve materials has not been verified by the FDA and contact of The sleeves/accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity.

Clinical Test Summary

Clinical Testing was not required to demonstrate the substantial equivalence of the LX9max to its predicate / reference device.

8. Conclusion [21 CFR 807.92(b)(3)]

The LX9max has similar intended use and technical characteristics to the predicate device. Based on that information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Therefore, the subject device is substantially equivalent the predicate device.

Regulation Number and Section

§ 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).