(24 days)
K211460 - Air Relax Model AR-3.0
Not Found
No
The device description details a mechanical system with user-controlled settings for pressure and inflation sequence. There is no mention of any adaptive or learning capabilities, data analysis, or complex algorithms that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is intended for "temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas," which are therapeutic benefits.
No
The device is described as an inflatable tube massager intended for temporary relief of minor muscle aches and increased circulation, simulating kneading and stroking. Its function is to provide therapy, not to identify or characterize medical conditions.
No
The device description clearly outlines hardware components including an air compressor unit, inflatable garments, plastic air tubing, and a control system with a front panel display and buttons. While it has a control system, it is integrated with physical hardware for operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for temporary relief of muscle aches and increased circulation through mechanical massage using inflatable garments. This is a physical therapy/rehabilitation type of use, not a diagnostic one.
- Device Description: The description details a powered inflatable massager that applies pressure to the body. It does not involve analyzing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
- Performance Studies: The performance studies focus on bench testing related to controls, indicators, and safety standards, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Air Relax Pro Model AR-4.0 operates in vivo (on the body) and provides a physical therapy-like treatment.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
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 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
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.
K211460 - Air Relax Model AR-3.0
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
§ 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).
0
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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.
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.
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
2
Indications for Use
510(k) Number (if known)
K212491
Device Name
Air Relax Pro Model AR-4.0
Indications for Use (Describe)
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.
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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FORM FDA 3881 (6/20)
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3
510(k) Summary K212491
| Date Prepared: | July 23, 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 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:
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
4
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
5
510(k) Summary Page 3 of 7
| Model Name
510(k)
Number | Subject Device
Air Relax Pro
Model AR-4.0
K212491 | Predicate Device
Air Relax Plus
Model AR-3.0
K211460 | Comment |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II Device, IRP
(21 CFR890.5650) | Class II Device, IRP
(21 CFR890.5650) | Identical |
| 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 Model
AR-4.0 simulates
kneading and stroking of
tissues by using an
inflatable garment | The Air Relax Plus Model
AR-3.0 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
Plus Model AR-3.0
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 | 100240V, 50/60Hz | 100240V, 50/60Hz | Identical |
| Device
Pressure
range | 40 - 170 mmHg | 60 - 170 mmHg | Similar to
predicate except
low pressure, it
does not affect
safety and
effectiveness. |
| Garments
material | Nylon with a
Polyurethane
Laminate | Nylon with a
Polyurethane
Laminate | Identical |
| Leg
Attachment | Yes
Size "2" : 34 X 15.35
Size "3" : 38.2 X 15.35
Size "4" : 42 X 15.35 | Yes
Size "2" : 34 X 15.35
Size "3" : 38.2 X 15.35
Size "4" : 42 X 15.35 | Identical in size
and materials.
Number of
Inflatable garment
segments differs. |
| Model Name
510(k)
Number | Subject Device
Air Relax Pro
Model AR-4.0
K212491 | Predicate Device
Air Relax Plus
Model AR-3.0
K211460 | Comment |
| Arm
Attachment | Yes
Size "1" : 34 X 15.35
Size "2" : 39.3 X 15.35 | Yes
Size "1" : 34 X 15.35
Size "2" : 39.3 X 15.35 | Identical in size
and materials.
Number of
Inflatable garment
segments differs. |
| Shorts
Attachment | Yes
Size "1" : 20.8 X 32.5
Size "2" : 24.6 X 32.5 | Yes
Size "1" : 20.8 X 32.5
Size "2" : 24.6 X 32.5 | Identical in size
and materials.
Number of
Inflatable garment
segments differs. |
| Number of
Inflatable
garment
segments | 6 | 4 | No impact on
safety and
effectiveness |
| Weight | 2.2 kg (4.85 pounds) | 1.67kg (3.7 pounds) | Weight is
different but it
does not affect
safety and
effectiveness. |
| Dimensions
(W x H x D) | 7.7" x 7.1" x 10.4" | 9.5" x 4.7" x 7.5" | Size is different
but it does not
affect safety and
effectiveness. |
| 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 :
"PROG" mode inflates
and deflates chambers
from bottom up, one at a
time
"SEQT" mode also
inflates chambers from
bottom up, but maintains
pressure in lower
chambers as works its | 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. | Similar to
predicate.
Differences do
not affect safety
and effectiveness. |
| Model Name
510(k)
Number | Subject Device
Air Relax Pro
Model AR-4.0
K212491 | Predicate Device
Air Relax Plus
Model AR-3.0
K211460 | Comment |
| | "OVLAY" mode is
inflates all chambers and
maintained pressure at
same time and release
pressure all chambers.
"DRAIN" mode is mixed
mode of SEQT and
PROG | "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 | |
| Treatment
Duration | 5-95 minutes | 15 or 30 minutes | Extended duration
for subject device
but predicate time
can be re-enabled
any number of
times so no
significant
difference |
Table of the Similarities and Differences of Subject vs. Predicate Device
6
510(k) Summary Page 4 of 7
7
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
9
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.