The Air Relax Plus Model AR-3.0 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 Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

This submission is for the Diode Art Engineering Air Relax Plus Model AR-3.0. The Air Relax Plus Model AR-3.0 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 from a separately approved external IEC 60601-1 compliant power supply or optional battery pack.

The Air Relax Plus Model AR-3.0 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 Plus Model AR-3.0 contains an air compressor with a system control that allows the user to adjust the amount of air coming from the air compressorand 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 Plus Model AR-3.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provides a proprietary keyed connector to the tubing which connects to the garment. The tubing connector to 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. There are four pressure levels with approximate pressure levels as below:

Level 1: 60 mmHg Level 2: 100 mmHg Level 3: 140 mmHg Level 4: 170 mmHg

There are three modes (Progressive, Sequential, Full massage P, S and F) that determine the inflation sequence.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Air Relax Plus Model AR-3.0, comparing it to a predicate device (Air Relax Model AR-1.0/AR-2.0, K191441) and another reference device (Rapid Reboot Compression Therapy System, K182668, inferred). The document focuses on demonstrating substantial equivalence for regulatory clearance rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or performance metrics against pre-defined thresholds.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable or not explicitly provided in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a legally marketed predicate, not necessarily to prove absolute effectiveness against novel criteria with dedicated clinical trials.

The document primarily relies on bench testing and comparison to the predicate device's established safety and performance profile.

Here's a breakdown of the information that can be extracted, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in the context of a 510(k) for a device like this is typically demonstrated by meeting recognized standards and by showing similar performance characteristics to the predicate device. Explicit quantitative acceptance criteria with numerical targets for clinical performance are not presented. Instead, the "acceptance criterion" is implicitly demonstrating that the new device is substantially equivalent to the predicate and complies with relevant safety standards.

Criterion Type	Acceptance Criterion (Implicit)	Reported Device Performance (Comparative)
Indications for Use	Identical to predicate device for temporary relief of minor muscle aches and pains and temporary increase in circulation.	Identical: "The Air Relax Plus Model AR-3.0 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 Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment."
Classification	Class II Device, IRP (21 CFR 890.5650)	Identical: Class II Device, IRP (21 CFR 890.5650)
OTC or Prescription	Over-The-Counter Use	Identical: OTC
Environment of Use	Clinics, hospital, athlete training, and home environments.	Identical: Clinics, hospital, athlete training, and home environments.
Compliance with Standards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	Identical: ES 60601-1, IEC 60601-1-2, IEC 60601-1-11. Bench testing confirmed compliance.
Mode of Operation	Sequential/Peristaltic, with options for various inflation sequences.	Identical principle: Sequential/Peristaltic. Subject device has modes "P", "S", "F", and "Target" (user selects specific chamber). Predicate has "A", "B", "C", and "Manual" (user selects specific chamber). These are described as "Identical to predicate except mode names differ."
Power	Safe and effective operation under specified power.	Different but acceptable: Subject device: 100~240V, 50/60Hz. Predicate: 120V, 60Hz. "Although the power rating of the subject device is different, both devices comply with ANSI/AAMI ES60601-1, so the difference does not affect safety and effectiveness."
Device Pressure Range	Operational pressure range for therapeutic effect.	Lower range than predicate: Subject device: 60 - 170 mmHg. Predicate: 0 - 230 mmHg. The document does not state this lower range affects safety or effectiveness given the intended use.
Garment Material	Safe and durable materials for patient contact.	Identical: Nylon with a Polyurethane Laminate.
Garment Sizes	Appropriate sizes for various body parts.	Leg Garment: Identical to predicate in size, construction, and materials. Arm Garment: Yes (Long: 13.8" x 33.5") vs. Predicate "No" / Reference "Yes" (Regular: 18" x 38", Long: 18" x 44"). Described as "Similar in size and construction. Materials are identical to K191441." Hip Garment: Yes (Large: 24.5" x 31.5") vs. Predicate "No" / Reference "Yes" (Regular: 26" x 32", Large: 26" x 35"). Described as "Similar in size and construction. Materials are identical to K191441."
Safety Features	User control to stop/pause therapy.	Identical: "Button at control unit allows user to stop or pause therapy session at any time."
Weight & Dimensions	Comparable to predicate for similar use.	Identical: Weight 1.67 kg (3.7 pounds), Dimensions 9.5" x 4.7" x 7.5".
Housing Materials	Durable and safe enclosure.	Identical: Molded ABS enclosure.
Patient Contact	Non-conductive materials.	Identical: Non-conductive garments.
Treatment Time	User-selectable therapy duration.	Similar but limited: Subject device: 15, 30 minutes. Reference device: 10, 20, 30 minutes with option to add 10 mins. "Similar to K182668 except time is limited to 30 minutes in subject device."

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- No clinical or animal testing was performed to generate a "test set" in the traditional sense for evaluating diagnostic or predictive performance.
- Bench testing was done to verify controls, indicators, and performance, but the sample size (e.g., number of units tested, number of cycles) is not provided.
Data Provenance: Not applicable, as no clinical/animal data was generated. Bench testing would be internal lab data.

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

Not applicable. There was no clinical study requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There was no clinical study requiring adjudication.

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. The device is a massager, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable. No ground truth in the clinical sense was required for this type of device and regulatory submission. The "ground truth" for proving substantial equivalence relies on documentation of design, materials, and bench test performance against established safety standards, and direct comparison to the predicate device.

8. The sample size for the training set

Not applicable. No training set was used as this device does not involve machine learning or AI.

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

Not applicable. No training set was used.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

May 25, 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: K211460

Trade/Device Name: Air Relax Plus Model AR-3.0 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: May 10, 2021 Received: May 11, 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/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.

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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.

Vivek Pinto, PhD 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

Enclosure

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Indications for Use

510(k) Number (if known) K211460

Device Name Air Relax Plus Model AR-3.0

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) SummaryK211460
Date Prepared:	April 29, 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 Plus Model AR-3.0
Common/Usual Name:	Powered Inflatable Tube Massager
Classification Name:	IRP - Massager Powered Inflatable Tube (CFR 890.5650
Predicate Devices:	K191441 – Air Relax Model AR-1.0/AR-2.0

Device Description:

The device is a Class II, type BF applied part that receives power from 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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which connects to the garment. The tubing connector to 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. There are four pressure levels with approximate pressure levels as below:

Level 1: 60 mmHg Level 2: 100 mmHg Level 3: 140 mmHg Level 4: 170 mmHg

There are three modes (Progressive, Sequential, Full massage P, S and F) that determine the inflation sequence.

Indications for Use:

The Air Relax Plus Model AR-3.0 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 Plus Model AR-3.0 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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Model Name510(k)Number	Subject Device	Predicate Device	Comment
	Air Relax Plus Model AR-3.0510(k) K211460	Air Relax Model AR-1.0/AR-2.0510(k) K191441
Classification	Class II Device, IRP (21CFR890.5650)	Class II Device, IRP (21CFR890.5650)	Identical
Indicationsfor use	The Air Relax Plus Model AR-3.0 is intended for thetemporary relief of minormuscle aches and pains and fortemporary increase incirculation to the treated areasin people who are in goodhealth. The Air Relax PlusModel AR-3.0 simulateskneading and stroking oftissues by using an inflatablegarment	The Air Relax /Compressiblelimb Sleeve System (AR-1.0,AR-2.0) is intended for thetemporary relief of minor muscleaches and pains and for thetemporary increase incirculation to the treated areas inpeople who are in good health.The Air Relax/ CompressibleLimb Sleeve System (Model:AR-1.0, AR-2.0) simulateskneading and stroking of tissuesby using an 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	120 V, 60Hz	Although thepower rating ofthe subject deviceis differentboth devicescomply withANSI/AAMIES60601-1, so thedifference doesnot affect safetyand effectiveness.
DevicePressurerange	60 - 170 mmHg	0-230 mmHg	Lowerrange thanK191441
Garmentsmaterial	Nylon with a PolyurethaneLaminate	Nylon with a PolyurethaneLaminate	Identical withK191441
Model Name	Subject Device	Predicate Device	Comment
510(k)	Air Relax Plus Model AR-3.0	Air Relax Model AR-1.0/AR-
Number	510(k) K211460	2.0510(k) K191441
Leg Garment	Yes size in inches:L 13.4 x 8.25 x 35.6XL 15.4 x 8.25 x 43.1XXL 15.4 x 8.25 x 47.0	Yes size in inches:L 13.4 x 8.25 x 35.6XL 15.4 x 8.25 x 43.1XXL 15.4 x 8.25 x 47.0	Identical in size,construction andmaterials
Arm Garment	Yes	No	See referencedevice comparisonbelow
Hip Garment	Yes	No	See referencedevice comparisonbelow
Number ofInflatablegarmentsegments	4	4	Identical
Weight	1.67kg (3.7 pounds)	1.67kg (3.7 pounds)	Identical
Dimensions(W x H x D)	9.5" x 4.7" x 7.5"	9.5" x 4.7" x 7.5"	Identical
HousingMaterials andConstructions	Molded ABS enclosure	Molded ABS enclosure	Identical
Patientcontact	Non-conductive garments	Non-conductive garments	Identical
SafetyFeatures	Button at control unit allowsuser to stop or pausetherapy session at any time.	Button at control unit allowsuser to stop or pausetherapy session at any time.	Identical
Modes	4 Modes :"P" mode inflatesand deflates chambers frombottom up, one at a time"S" mode also inflateschambers from bottom up, butmaintains pressure in lowerchambers as works its way totop."F" mode is inflates allchambers and maintainedpressure at same time andrelease pressure all chambers.At "Target" mode, user canselect specific chamber toinflates	4 Modes :"A" mode inflatesand deflates chambers frombottom up, one at a time"B" mode also inflateschambers from bottom up, butmaintains pressure in lowerchambers as works its way totop."C" mode is inflates allchambers and maintainedpressure at same time andrelease pressure all chambers.At "Manual" mode, user canselect specific chamber toinflates	Identical topredicate exceptmode names differ
Model Name510(k)Number	Subject Device	Reference Device	Comment
Indicationsfor use	The Air Relax PlusModel AR-3.0 is intended for thetemporary relief ofminor muscle achesand pains and fortemporary increase incirculation to thetreated areas inpeople who are ingood health. The AirRelax Plus ModelAR-3.0 simulateskneading andstroking of tissues byusing an inflatablegarment	The Rapid RebootCompression TherapySystem is indicated forthe temporary relief ofminor muscle aches andpains and for temporaryincrease in circulation tothe treated areas inpeople who are in goodhealth. The RapidReboot CompressionTherapy Systemsimulates kneading andstroking of tissues byusing an inflatablegarment.	Identical
TreatmentTime	User determinesTherapy time.Choosefrom 15, 30	User determinesTherapy time. Choosefrom 10, 20, or 30minute session time,with option to addadditional 10 minutestoany therapy time.	Similar to K182668except time is limitedto 30 minutes insubject device
ArmGarment	YesLong : 13.8" x 33.5"Image: Arm Garment	YesRegular : 18" x 38"Long : 18" x 44"Image: Arm Garment	Similar in size andconstruction. Materialsare identical toK191441
Hip Garment	YesLarge : 24.5" x 31.5"Image: Hip Garment	YesRegular : 26" x 32"Large : 26" x 35"Image: Hip Garment	Similar in size andconstruction. Materialsare identical toK191441

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

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Comparison to reference device:

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In the above detailed tables we have compared the Air Relax Plus Model AR-3.0 to the predicate for equivalence of:

Indications -

Prescriptive - The Air Relax Plus Model AR-3.0 is OTC as is the predicate.

Design, Technology and Principle of Operation - The Air Relax Plus Model AR-3.0 has equivalent design and features when compared to the predicate and has identical technology to the predicate.

Performance and Specifications - The Air Relax Plus Model AR-3.0 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The subject device declares compliance with ES 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 Relax Plus Model AR-3.0 are the inflatable garments which are identical to the predicate device 510(K) K191441.

Patient Population -

The Air Relax Plus Model AR-3.0 and predicates are indicated for adults.

Environment of Use -

The Air Relax Plus Model AR-3.0 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 effectiveness concerns.

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Performance Testing

Bench:

The device has been tested to ensure that 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

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 effectiveness concerns.

Substantial Equivalence Rationale

The Air Relax Plus Model AR-3.0 is viewed as substantially equivalent to the predicate device because:

Indications - are identical to the predicate

Prescriptive - The Air Relax Plus Model AR-3.0 and predicate are OTC.

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Design, Technology and Principle of Operation - The Air Relax Plus Model AR-3.0 has equivalent design and features when compared to the predicate and has identical technology to the predicate.

Performance and Specifications – The Air Relax Plus Model AR-3.0 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The subject device declares compliance with ES 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 Relax Plus Model AR-3.0 are the inflatable garments they are identical to the predicate.

Environment of Use - Clinics, hospital, athlete training, and home environments, not specified for predicate but predicate is OTC.

Features - The Air Relax Plus Model AR-3.0 has equivalent features when compared to the predicate.

Conclusion

The Air Relax Plus Model AR-3.0 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).