The Air Relax Pro Model AR-4.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Air Relax Pro Model AR-4.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health.

The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack.

The Air Relax Pro Model AR-4.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment. A description of each of these components is provided below. The hip garment is also referred to as "shorts".

The user interface is a front panel display and buttons.

The Air Relax Pro Model AR-4.0 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable garment.

There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

The user interface of the Air Relax Pro Model AR-4.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provide a proprietary keyed connector to the tubing which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.

Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg

There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments.

AI/ML Overview

The provided text is a 510(k) Summary for the Air Relax Pro Model AR-4.0, a powered inflatable tube massager. It focuses on demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) rather than providing detailed acceptance criteria and a study proving those criteria for a novel device.

Therefore, much of the requested information regarding detailed acceptance criteria for specific performance metrics and a dedicated study to prove these against novel criteria is not present in the provided document. The document primarily highlights the similarities to a predicate device and relies on compliance with general medical device standards.

Here's an analysis based on the available information:

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

The document does not explicitly present a table of quantitative acceptance criteria for the Air Relax Pro Model AR-4.0's performance in terms of its intended therapeutic effect (e.g., specific thresholds for "temporary relief of minor muscle aches" or "temporary increase in circulation").

Instead, the document establishes "acceptance" by demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) through a comparative table (page 5). The criteria for acceptance are implicitly that the new device is as safe and effective as the predicate, meaning any differences do not raise new safety or efficacy concerns.

Here's a summary of the comparative performance and specifications, which serve as the implicit "acceptance criteria" through equivalence:

Feature/Criteria	Air Relax Pro Model AR-4.0 (Subject Device)	Air Relax Plus Model AR-3.0 (Predicate Device)	Comment (Acceptance Status)
Indications for Use	Identical	Identical	Identical (Accepted)
OTC or Prescription	OTC	OTC	Identical (Accepted)
Environment of Use	Clinics, hospital, athlete training, home	Clinics, hospital, athlete training, home	Identical (Accepted)
Compliance with Standards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	Identical (Accepted)
Mode of Operation	Sequential/Peristaltic	Sequential/Peristaltic	Identical (Accepted)
Power	100~240V, 50/60Hz	100~240V, 50/60Hz	Identical (Accepted)
Device Pressure Range	40 - 170 mmHg	60 - 170 mmHg	Similar (Predicate has a higher minimum pressure). Comment: "Similar to predicate except low pressure, it does not affect safety and effectiveness." (Considered Acceptable)
Garments material	Nylon with a Polyurethane Laminate	Nylon with a Polyurethane Laminate	Identical (Accepted)
Leg Attachment Sizes	Size "2": 34 X 15.35, "3": 38.2 X 15.35, "4": 42 X 15.35	Size "2": 34 X 15.35, "3": 38.2 X 15.35, "4": 42 X 15.35	Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness)
Arm Attachment Sizes	Size "1": 34 X 15.35, "2": 39.3 X 15.35	Size "1": 34 X 15.35, "2": 39.3 X 15.35	Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness)
Shorts Attachment Sizes	Size "1": 20.8 X 32.5, "2": 24.6 X 32.5	Size "1": 20.8 X 32.5, "2": 24.6 X 32.5	Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness)
Number of Inflatable Garment Segments	6	4	Different. Comment: "No impact on safety and effectiveness" (Considered Acceptable)
Weight	2.2 kg (4.85 pounds)	1.67kg (3.7 pounds)	Different. Comment: "Weight is different but it does not affect safety and effectiveness." (Considered Acceptable)
Dimensions (W x H x D)	7.7" x 7.1" x 10.4"	9.5" x 4.7" x 7.5"	Different. Comment: "Size is different but it does not affect safety and effectiveness." (Considered Acceptable)
Housing Materials and Constructions	Molded ABS enclosure	Molded ABS enclosure	Identical (Accepted)
Patient contact	Non-conductive garments	Non-conductive garments	Identical (Accepted)
Safety Features	Button at control unit allows stop/pause	Button at control unit allows stop/pause	Identical (Accepted)
Modes	"PROG", "SEQT", "OVLAY", "DRAIN"	"P", "S", "F", "Target"	Similar. Comment: "Similar to predicate. Differences do not affect safety and effectiveness." (Considered Acceptable) Note: "OVLAY" vs "F" seem functionally similar, "DRAIN" vs "Target" seem different but deemed not to affect safety/effectiveness.
Treatment Duration	5-95 minutes	15 or 30 minutes	Different. Comment: "Extended duration for subject device but predicate time can be re-enabled any number of times so no significant difference." (Considered Acceptable)

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

The document states:

"No animal testing was performed" (page 8)
"No clinical testing was performed" (page 9)

This indicates that there was no specific test set of patient data used to prove the device's performance against clinical acceptance criteria. The evaluation was primarily based on:

Engineering bench testing (controls, indicators, performance)
Compliance with recognized electrical and medical device safety standards (AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
Demonstration of substantial equivalence to a legally marketed predicate device.

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. Since no clinical test set was used, there was no need for experts to establish ground truth from patient data. The "ground truth" for substantial equivalence was established by the FDA's review process comparing the device to the predicate based on technical specifications and declared compliance with standards.

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

Not applicable. No clinical test set or human interpretation was involved that would require an adjudication method.

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 massager, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical images. Therefore, an MRMC study is not relevant.

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

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

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

For the purpose of this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on:

Established performance of the predicate device: The predicate (Air Relax Model AR-3.0) is already legally marketed and presumed safe and effective for its indications.
Compliance with recognized industry standards: The device's adherence to standards like IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment) provides "ground truth" for its electrical and mechanical safety and basic performance characteristics.
Bench testing: Verifying the function of controls, indicators, and overall performance through engineering tests.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model requiring a training set.

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

Not applicable. See point 8.

Summary

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September 2, 2021

Diode Art Engineering doing business as Air Relax % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K212491

Trade/Device Name: Air Relax Pro Model AR-4.0 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: August 7, 2021 Received: August 9, 2021

Dear Prithul Bom:

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/cdrl/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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 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.

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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Indications for Use

510(k) Number (if known)

K212491

Device Name

Air Relax Pro Model AR-4.0

Indications for Use (Describe)

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 K212491

Date Prepared:	July 23, 2021
Applicant	Diode Art Engineering doing business as Air Relax9535 Brasher StPico Rivera, CA 90660Tel - 1.323.285.4231
Official Contact:	Beomjoon Lee, General Manager
Proprietary or Trade Name:	Air Relax Pro Model AR-4.0
Common/Usual Name:	Powered Inflatable Tube Massager
Classification Name:	IRP - Massager Powered Inflatable Tube (CFR 890.5650)
Predicate Devices:	K211460 - Air Relax Model AR-3.0

Device Description:

The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack.

The user interface is a front panel display and buttons.

There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

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510(k) Summary Page 2 of 7

which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.

Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg

There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments..

Intended Use / Indications for Use:

The Air Relax Pro Model AR-4.0 is intended 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 Pro simulates kneading and stroking of tissues by using an inflatable garment.

Patient Population: Adults

Environments of Use:

Clinics, hospital, athlete training, and home environments

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510(k) Summary Page 3 of 7

Model Name510(k)Number	Subject DeviceAir Relax ProModel AR-4.0K212491	Predicate DeviceAir Relax PlusModel AR-3.0K211460	Comment
Classification	Class II Device, IRP(21 CFR890.5650)	Class II Device, IRP(21 CFR890.5650)	Identical
Indicationsfor use	The Air Relax Pro ModelAR-4.0 is intended for thetemporary relief of minormuscle aches and painsand for temporaryincrease in circulation tothe treated areas in peoplewho are in good health.The Air Relax Pro ModelAR-4.0 simulateskneading and stroking oftissues by using aninflatable garment	The Air Relax Plus ModelAR-3.0 is intended for thetemporary relief of minormuscle aches and pains andfor the temporary increasein circulation to the treatedareas in people who are ingood health. The Air RelaxPlus Model AR-3.0simulates kneading andstroking of tissues by usingan inflatable garment	Identical
OTC orPrescription	OTC	OTC	Identical
Environmentof Use	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athletetraining, and homeenvironments	Identical
Compliancewithstandards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	Identical
Mode ofOperation	Sequential/Peristaltic	Sequential/Peristaltic	Identical
Power	100~240V, 50/60Hz	100~240V, 50/60Hz	Identical
DevicePressurerange	40 - 170 mmHg	60 - 170 mmHg	Similar topredicate exceptlow pressure, itdoes not affectsafety andeffectiveness.
Garmentsmaterial	Nylon with aPolyurethaneLaminate	Nylon with aPolyurethaneLaminate	Identical
LegAttachment	YesSize "2" : 34 X 15.35Size "3" : 38.2 X 15.35Size "4" : 42 X 15.35	YesSize "2" : 34 X 15.35Size "3" : 38.2 X 15.35Size "4" : 42 X 15.35	Identical in sizeand materials.Number ofInflatable garmentsegments differs.
Model Name510(k)Number	Subject DeviceAir Relax ProModel AR-4.0K212491	Predicate DeviceAir Relax PlusModel AR-3.0K211460	Comment
ArmAttachment	YesSize "1" : 34 X 15.35Size "2" : 39.3 X 15.35	YesSize "1" : 34 X 15.35Size "2" : 39.3 X 15.35	Identical in sizeand materials.Number ofInflatable garmentsegments differs.
ShortsAttachment	YesSize "1" : 20.8 X 32.5Size "2" : 24.6 X 32.5	YesSize "1" : 20.8 X 32.5Size "2" : 24.6 X 32.5	Identical in sizeand materials.Number ofInflatable garmentsegments differs.
Number ofInflatablegarmentsegments	6	4	No impact onsafety andeffectiveness
Weight	2.2 kg (4.85 pounds)	1.67kg (3.7 pounds)	Weight isdifferent but itdoes not affectsafety andeffectiveness.
Dimensions(W x H x D)	7.7" x 7.1" x 10.4"	9.5" x 4.7" x 7.5"	Size is differentbut it does notaffect safety andeffectiveness.
HousingMaterials andConstructions	Molded ABS enclosure	Molded ABS enclosure	Identical
Patientcontact	Non-conductive garments	Non-conductive garments	Identical
SafetyFeatures	Button at control unitallows user to stop orpause therapy session atany time.	Button at control unitallows user to stop orpause therapy session atany time.	Identical
Modes	4 Modes :"PROG" mode inflatesand deflates chambersfrom bottom up, one at atime"SEQT" mode alsoinflates chambers frombottom up, but maintainspressure in lowerchambers as works its	4 Modes :"P" mode inflatesand deflates chambersfrom bottom up, one at atime"S" mode also inflateschambers from bottomup, but maintains pressurein lower chambers asworks its way to top.	Similar topredicate.Differences donot affect safetyand effectiveness.
Model Name510(k)Number	Subject DeviceAir Relax ProModel AR-4.0K212491	Predicate DeviceAir Relax PlusModel AR-3.0K211460	Comment
	"OVLAY" mode isinflates all chambers andmaintained pressure atsame time and releasepressure all chambers."DRAIN" mode is mixedmode of SEQT andPROG	"F" mode is inflates allchambers and maintainedpressure at same time andrelease pressure allchambers.At "Target" mode, usercan select specificchamber to inflates
TreatmentDuration	5-95 minutes	15 or 30 minutes	Extended durationfor subject devicebut predicate timecan be re-enabledany number oftimes so nosignificantdifference

Table of the Similarities and Differences of Subject vs. Predicate Device

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510(k) Summary Page 4 of 7

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510(k) Summary Page 5 of 7

Substantial Equivalence Discussion

In the above detailed table we have compared the Air Relax Pro Model AR-4.0 to the predicate for equivalence of:

Indications -

The Air Relax Pro Model AR-4.0 is intended 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 Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment. These indications are identical to the predicate.

Prescriptive - The Air Relax Pro Model AR-4.0 is OTC as is the predicate

Design, Technology and Principle of Operation - The Air Relax Pro Model AR-4.0 has equivalent design and features when compared to the predicate and have identical technology to the predicate

Performance and Specifications - The Air Relax Pro Model AR-4.0 has equivalent specifications of performance when compared to the predicate.

Compliance with standards – The Air Relax Pro Model AR-4.0 declares compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate.

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510(k) Summary Page 6 of 7

Materials -

The patient contacting materials of the Air Relax Pro Model AR-4.0 are the inflatable garments which are identical to the predicate device 510(K) K211460

Patient Population -

The Air Relax Pro Model AR-4.0and predicate are indicated for adults

Environment of Use -

The Air Relax Pro Model AR-4.0 and predicates are for use in clinics, hospital, athlete training, and home environments.

Differences -

There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

Performance Testing

Bench:

The device has been tested to insure that it all requirements have been met, this includes:

Testing of all controls
Testing of all indicators ●
Testing of performance ●

The device has also been tested to the requirements of the following standards:

. AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances -. Requirements and Tests
. IEC 60601-1-11: 2015, Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Animal:

No animal testing was performed

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510(k) Summary Page 7 of 7

Clinical:

No clinical testing was performed

Differences -

There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

Substantial Equivalence Rationale

The Air Relax Pro Model AR-4.0 is viewed as substantially equivalent to the predicate device because:

Indications - are identical to the predicate

Prescriptive – The Air Relax Pro Model AR-4.0 and predicate are OTC.

Design. Technology and Principle of Operation - The Air Relax Pro Model AR-4.0 has equivalent design and features when compared to the predicate and have the identical technology to the predicate.

Performance and Specifications - The Air Relax Pro Model AR-4.0 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The Air Relax Pro Model AR-4.0 declares compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate

Materials - The patient contacting materials of the Air Air Relax Pro Model AR-4.0 are are identical to the predicate.

Environment of Use - Clinics, hospital, athlete training, and home environments, identical to the predicate.

Features - The Air Relax Pro Model AR-4.0 has equivalent features when compared to the predicate.

Conclusion

The Air Relax Pro Model AR-4.0 is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.

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).