Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a mechanical device with user-controlled settings for pressure and inflation sequence. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML.

Therapeutic

Yes
Explanation: The device is intended for the temporary relief of minor muscle aches and for temporary increase in circulation, which are therapeutic claims.

Diagnostic

No

The device is described as an "inflatable tube massager" intended for "temporary relief of minor muscle aches and pains" and "temporary increase in circulation." It simulates manual massage and has no features or stated purpose related to diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as an air compressor unit, control system, inflatable garment, plastic air tubing, and a user interface with a front panel display and buttons. This indicates it is a hardware device with integrated software for control.

IVD (In Vitro Diagnostic)

Based on the provided information, the Air Relax Plus Model AR-3.0 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the temporary relief of minor muscle aches and temporary increase in circulation to treated areas. This is a physical therapy/massage function, not a diagnostic test performed on samples taken from the body.
Device Description: The device description clearly outlines a powered inflatable tube massager that simulates kneading and stroking using air pressure. It does not involve analyzing biological samples (blood, urine, tissue, etc.).
Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing in vitro samples for diagnostic purposes. There is no mention of reagents, assays, or any form of laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Air Relax Plus Model AR-3.0 does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IRP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults

Intended User / Care Setting

Clinics, hospital, athlete training, and home environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191441

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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.

1

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)

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.

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
K211460 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 29, 2021 |
| Applicant | Diode Art Engineering doing business as Air Relax
9535 Brasher St
Pico Rivera, CA 90660
Tel – 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:

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

4

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

5

| Model Name
510(k)

Number	Subject Device	Predicate Device	Comment
	Air Relax Plus Model AR-3.0
510(k) K211460	Air Relax Model AR-1.0/AR-
2.0
510(k) K191441
Classification	Class II Device, IRP (21
CFR890.5650)	Class II Device, IRP (21
CFR890.5650)	Identical
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	The Air Relax /Compressible
limb Sleeve System (AR-1.0,
AR-2.0) is intended for the
temporary relief of minor muscle
aches and pains and for the
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	Identical
OTC or
Prescription	OTC	OTC	Identical
Environment
of Use	Clinics, hospital, athlete
training, and home
environments	Clinics, hospital, athlete
training, and home
environments	Identical
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
Mode of
Operation	Sequential/Peristaltic	Sequential/Peristaltic	Identical
Power	100~240V, 50/60Hz	120 V, 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	60 - 170 mmHg	0-230 mmHg	Lower
range than
K191441
Garments
material	Nylon with a Polyurethane
Laminate	Nylon with a Polyurethane
Laminate	Identical with
K191441
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	2.0
510(k) K191441
Leg Garment	Yes size in inches:
L 13.4 x 8.25 x 35.6
XL 15.4 x 8.25 x 43.1
XXL 15.4 x 8.25 x 47.0	Yes size in inches:
L 13.4 x 8.25 x 35.6
XL 15.4 x 8.25 x 43.1
XXL 15.4 x 8.25 x 47.0	Identical in size,
construction and
materials
Arm Garment	Yes	No	See reference
device comparison
below
Hip Garment	Yes	No	See reference
device comparison
below
Number of
Inflatable
garment
segments	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
Housing
Materials and
Constructions	Molded ABS enclosure	Molded ABS enclosure	Identical
Patient
contact	Non-conductive garments	Non-conductive garments	Identical
Safety
Features	Button at control unit allows
user to stop or pause
therapy session at any time.	Button at control unit allows
user to stop or pause
therapy session at any time.	Identical
Modes	4 Modes :
"P" mode inflates
and deflates chambers from
bottom up, one at a time

"S" mode also inflates
chambers from bottom up, but
maintains pressure in lower
chambers as works its way to
top.

"F" mode is inflates all
chambers and maintained
pressure at same time and
release pressure all chambers.

At "Target" mode, user can
select specific chamber to
inflates | 4 Modes :
"A" mode inflates
and deflates chambers from
bottom up, one at a time

"B" mode also inflates
chambers from bottom up, but
maintains pressure in lower
chambers as works its way to
top.

"C" mode is inflates all
chambers and maintained
pressure at same time and
release pressure all chambers.

At "Manual" mode, user can
select specific chamber to
inflates | Identical to
predicate except
mode names differ |
| Model Name
510(k)
Number | Subject Device | Reference Device | Comment |
| 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 | The Rapid Reboot
Compression Therapy
System 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 Rapid
Reboot Compression
Therapy System
simulates kneading and
stroking of tissues by
using an inflatable
garment. | Identical |
| Treatment
Time | User determines
Therapy time.
Choosefrom 15, 30 | User determines
Therapy time. Choose
from 10, 20, or 30
minute session time,
with option to add
additional 10 minutes
to
any therapy time. | Similar to K182668
except time is limited
to 30 minutes in
subject device |
| Arm
Garment | Yes
Long : 13.8" x 33.5"
Image: Arm Garment | Yes
Regular : 18" x 38"
Long : 18" x 44"
Image: Arm Garment | Similar in size and
construction. Materials
are identical to
K191441 |
| Hip Garment | Yes
Large : 24.5" x 31.5"
Image: Hip Garment | Yes
Regular : 26" x 32"
Large : 26" x 35"
Image: Hip Garment | Similar in size and
construction. Materials
are identical to
K191441 |

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

6

7

Comparison to reference device:

8

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

Indications -

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. These indications are identical to the predicate.

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.

9

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.

10

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.