Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

AR-1.0, AR-2.0is combined with leg, foot, garments. Leg garment has four air chambers operated by STEP3 controller and foot has one air chamber operated by STEP1. STEP3 controls a leg garment compressing sequentially in order of foot, calf and thigh and then injecting fresh air inside a leg garment through holes of garment to prevent from generating sweat by long wear of a garment.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)". It is a submission to the FDA for market clearance, arguing for substantial equivalence to predicate devices.

Based on the provided text, the device did not undergo a clinical study or performance study to prove it meets specific acceptance criteria based on human or algorithm performance metrics. The submission argues for substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or human improvement with AI assistance) cannot be answered directly from this document because such a study was explicitly not performed.

Here's a breakdown of the information that can be extracted and an explanation of why other requested information is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are related to demonstrating substantial equivalence through adherence to recognized standards for safety and electrical performance, and through a comparative analysis against predicate devices. The implicit acceptance criterion is that the device is "as safe and effective" as the legally marketed predicates.
Reported Device Performance: The "performance" reported is primarily in terms of compliance with non-clinical standards and the comparison of technical specifications to predicate devices. No specific diagnostic accuracy or AI performance metrics are reported.

Acceptance Criteria (Implicit for SE)	Reported Device Performance (Compliance/Comparison)
Electrical Safety (IEC 60601-1:2014)	Device met IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility (EMC – IEC 60601-1-2:2016)	Device met IEC 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Home Healthcare Environment Requirements (IEC 60601-1-11:2015)	Device met IEC 60601-1-11:2015 Medical electrical equipment – Part 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.
Biocompatibility (EN ISO 10993-5:2009 for Cytotoxicity)	Device met EN ISO 10993-5:2009 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
Biocompatibility (EN ISO 10993-10:2010 for Irritation and Skin Sensitization)	Device met EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
Substantial Equivalence in Intended Use	The device's intended use ("temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment") is stated to be "Same as K182668 (Primary predicate) and K193354 (Secondary predicate)".
Substantial Equivalence in Principle of Operation, Technological Characteristics, and Safety/Effectiveness	The document concludes that the "subject device has same intended use and principle of operation, similar technological characteristics as that of predicate devices." It also states, "the differences between these parameters would not adversely impact the safety and effectiveness" and that the device "is at least as safe and effective as the all predicate devices and technologically comparable to the reference device and doesn't raise any new safety and/or effectiveness concerns."

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

Not applicable. The document explicitly states: "No clinical study is included in this submission." Therefore, there is no "test set" in the sense of patient data for evaluating diagnostic or intervention performance. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility).

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 no clinical study was performed, there was no test set requiring expert-established ground truth.

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

Not applicable. No clinical study or test set for performance evaluation was conducted.

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 "Powered Inflatable Tube Massager," not an AI-powered diagnostic or AI-assisted interpretation device. The submission explicitly states no clinical study was done, and therefore no MRMC study.

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

Not applicable. This is a physical device (massager), not an algorithm or AI system.

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

Not applicable. No clinical study or performance evaluation requiring ground truth data was performed. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As above, no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

March 5, 2021

Maxstar Industrial Co., Ltd. % Chris Park General Manager Med.com 1809 Holland Dr Somerset, New Jersey 08873

Re: K191441

Trade/Device Name: Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 24, 2019 Received: May 30, 2019

Dear Chris Park:

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 avare 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 Actinclude 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-devices/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 L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92

The assigned 510(k) Number: K191441

1. Date of Preparation:02/12/2021
1. Sponsor Identification Maxstar Industrial Co Ltd Address: 152 - 12 Hwanggeum-ro 23beon-gil, Yangchon-eup, Gimpo-si, Gyeonggido, Korea of Republic Contact Person: YOUNG NAE YOON Position: General Manager Tel: +82 31 989 3543 Email: yoonyn@maxstar.co.kr

Official Correspondent J-R Kimt Address: 1809 holland dr, somerset, NJ, 08873, USA Email meddatcom@gmail.com

1. Identification of Proposed Device

Regulatory Information

Trade/proprietary Name	Air Relax/ Compressible Limb Sleeve System
Model No.	AR-1.0, AR-2.0
Common or Usual Name	Powered Inflatable Tube Massager
Regulation Name	Massager, Powered Inflatable Tube
Regulation Number	21 CFR 884.5650
Product Code	IRP (21 CFR 890.5650)
Regulatory Class	Class II

Intended Use Statement:

Device Description

As this manual includes use methods, maintenance and repair information of a devices, please read carefully for correct use and safe use.

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1. Identification of Predicate Device(s)
- Primary Predicate device
- K182668 -
- Trade/Device Name: Rapid Reboot Compression Therapy System -
- Company: Rapid Reboot Recovery Products, LLC -
- Regulation Number: 21 CFR 890.5650 -
- -Regulation Name: Powered Inflatable Tube Massager
- Regulatory Class: Class II -
- -Product Code: IRP

Secondary Predicate device

K193354 l
-Trade Name: Air Compression Therapy Device
-Model : S9019
-Company: Shenzhen Dongjilian Electronics Co.,Ltd.
Regulation Number: 21 CFR 890.5650 -
Regulation Name: Powered Inflatable Tube Massager l
-Regulatory Class: Class II
-Product Code: IRP

న. Non-Clinical TestConclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as

was Substantially Equivalent (SE) to the predicate device, including

A. Electrical Safety – IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
B. EMC – IEC 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests:
C. IEC 60601-1-11:2015 Medical electrical equipment – Part 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 healthcareenvironment
D. Biocompatibility – EN ISO 10993-5:2009 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
E. Biocompatibility – EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
1. Clinical TestConclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison A substantial equivalence table, which summarizes the similarities and differences between our devices, is attached to this section

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Device	Subject Device	Primary Predicate	Secondary Predicate	Comparison
Manufacturer	Maxstar Industrial Co.,Ltd.	Rapid Reboot RecoveryProducts, LLC	Shenzhen DongjilianElectronics Co., Ltd.	NA
510(k)Number	Not yet	K182668	K193354	NA
Model Name	AR-1.0, AR-2.0	Rapid Reboot CompressionTherapy System	S9019	NA
Classification	Class II Device, IRP(21 CFR890.5650)	Class II Device, IRP (21CFR890.5650)	Class II Device, IRP(21 CFR890.5650)	Same as all predicates.
Indicationsfor Use (IFU)	The Air Relax/Compressible limb SleeveSystem (AR-1.0, AR-2.0) isintended for the temporaryrelief of minor muscle achesand pains and for thetemporary increase incirculation to the treatedareas in people who are ingood health. The Air RelaxModel AR-1.0/AR-2.0simulates kneading and	The Rapid Reboot CompressionTherapy System is intended for thetemporary relief of minor muscleaches and pains and for thetemporary increase in circulation tothe treated areas in people who arein good health. The Rapid RebootCompression Therapy Systemsimulates kneading and stroking oftissues by using an inflatablegarment.	The Air CompressionTherapy Device is indicatedfor the temporary relief ofminor muscle aches and painsand for temporary increase incirculation to the treated areasin people who are in goodhealth. The Air CompressionTherapy Device simulateskneading and stroking oftissues by using an inflatablegarment	Same as K182668(Primary predicate) andK193354 (Secondarypredicate)
OTC or Rx	OTC	OTC	OTC	Same
Environment of Use:	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athlete training,and home environments	Clinics, hospital, athletetraining, and home environments	Same as K182668(Primary predicate)and K193354 (Secondarypredicate)
Standards	IEC 60601-1IEC 60601-1-2ISO 10993-5ISO 10993-10IEC 60601-1-11	IEC 60601-1IEC 60601-1-2ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-2ISO 10993-5ISO 10993-10IEC 60601-1-11	Same
Mode ofCompression	Sequential/Peristaltic	Sequential/Peristaltic	Sequential/Peristaltic	Same
Power Source	120 V, 60Hz	110 V, 60Hz	100-240V, 50/60Hz	SimilarNote 1
Therapy Time	Has 15 minute sessions.	User determines therapy time.Choose from 10, 20, or 30 minutesession time, with option to addadditional 10 minutes to any therapytime.	Has 20 minute sessions.	Similar with Primarypredicate.Session time is less thanSecondary predicateNote 2
Max PressureMin Pressure	0-230 mmHg	0-200 mmHg	0 to 240 mmHg	Lower than K193354(Secondary predicates)Little higher than K182668(primary predicate)Note 3
Number ofChambers:	4 Chambers	4 Chambers	3 chambers	Same as Primary predicate
CompressionApplicatorGarmentsSleeve	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	Nylon with a Polyurethanelaminate	Same
HousingMaterialAndConstructions	Molded ABS enclosureOrange: AR-1.0Navy: AR-2.0	Molded ABS enclosure	Molded ABS enclosure	Same types of housing material
Patientcontact	Non-conductive attachments	Non-conductive attachments	Non-conductive attachments	Same
PowerConsumption	60VA	30W	12W	Similar as Primary and Secondary predicateNote 4
Size andphoto	240 x 190 x 120/mmImage: [device with white and orange top and black bottom]Image: [black device]	10" x 6.5" x 5"Image: [black device with green screen]	10.2 x 5.9 x 25.6 (in)Image: [black device]	Similar with Primary predicate and secondary predicateNote 5
Weight	2.3kg	5.8 pounds	4.6 pounds
Modes(Inflationsequences, allpreprogrammed)(visualdescription)	3 mode"A" mode inflatesand deflates chambers frombottom up (distal to proximalchambers), one at a time.Image: [diagram of inflation sequence]"B" mode also inflates chambersfrom bottom up, but maintainspressure in lower chambers asworks its way to top. Then allchambers release pressure at sametime once all chambers havesequentially inflated.Image: [diagram of inflation sequence]"C"mode is inflates all chambersand maintained pressure at sametime and release pressure allchambers.Image: [diagram of inflation sequence]	2 modes:"A" mode inflates and deflateschambers from bottom up (distal toproximal chambers), one at a time.Image: [diagram of inflation sequence]"B" mode also inflates chambers frombottom up, but maintains pressure inlower chambers as works its way totop. Then all chambers release pressureat same time once all chambers havesequentially inflatedImage: [diagram of inflation sequence]	3 modeMode 1: Starting with the footchamber and progressing up thethigh chamber, each sectioncompresses and the pressuregradually rises to the pre-determined air pressure level,then decompresses.Image: [diagram of inflation sequence]Mode 2: Starting with the footchamber and progressing up thethigh, each section compressesand the pressure gradually risesto the pre-determined airpressure level, holds the airuntil the entire garment iscompressed. All three sectionsthen decompresssimultaneously.Mode 3: include two stage,Image: [diagram of inflation sequence]stage 1: it work according to themethod of mode 1, after thestage 1 is completed, it go tostage 2	Similar with Primary predicatee and secondary predicateNote 6Image: [no image]
"Leg" Attachment	Leg (consisting of foot, calf,knee, upper leg)	Leg (consisting of foot, calf, knee,upper leg), Arm, Hip	Leg (consisting of foot andcalf).	Similar with Primary predicate and secondary predicateNote 7
Leg AttachmentSizes	Sleeve (L) : 320740(mm)Sleeve (XL): 390890(mm)Sleeve (XXL) :390*990 (mm)	X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"	Sleeve : 260x730(mm)	Similar with Primary predicate and secondary predicateNote 7
Safety Features	Button on display allowsuser to stop or pausetherapy session at any time	Button on display allows user tostop or pause therapy session at anytime.	Standby button allowsuser to stop therapysession at any time	Same
SW/FirmwareMicroprocessor	Microprocessor	Microprocessor	Microprocessor	Same
Technology	Compressor and valvesystem which sequentiallyinflates cells of appliance	Compressor and valve systemwhich sequentially inflates cells ofappliance	Compressor and valvesystem which sequentiallyinflates cells of appliance	Same

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510(k) Summary

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510(k) Summary

The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) has been compared with Rapid Reboot Compression Therapy System (K182668), Air Compression Therapy Device (K193354). The subject device has same intended use and principle of operation, similar technological characteristics as that of predicate devices. Although there are several specifications that are different between the subject device and predicate devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate devices do not raise any problem of substantial equivalence. The subject devices is substantially equivalent to the predicate devices in safety and performance claims.

Substantially Equivalent (SE) Conclusion

Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) is substantially equivalent to the legally marketed the product (Rapid Reboot Compression Therapy System / Primary predicate and Air Compression Therapy Device S9019 / Secondary predicate) / in indication for use and similarly so it is mostly substantially equivalent in technological and performance characteristics.

Based on the Safety and Effectiveness test reports it is at least as safe and effective as the all predicate devices and technologically comparable to the reference device and doesn't raise any new safety and/or effectiveness concerns.

Hence, it is clear that Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) is substantially equivalent to that of the predicate devices.

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).