K Number

Device Name

Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

Manufacturer

Maxstar Industrial Co., Ltd.

Date Cleared

2021-03-05

(645 days)

Product Code

IRP

Regulation Number

890.5650

Intended Use

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

Device Description

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K182668, K193354

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on basic electrical and mechanical safety and biocompatibility, with no mention of AI/ML, image processing, or data-driven performance metrics.

Therapeutic

Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas," which describes a therapeutic purpose.

Diagnostic

The device is indicated for temporary relief of muscle aches and pains and increased circulation, simulating kneading and stroking of tissues. It does not mention any function for identifying, analyzing, or determining a medical condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like "leg, foot, garments" and "air chambers operated by STEP3 controller," indicating it is a physical device with software control, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The Air Relax/Compressible Limb Sleeve System works by applying external pressure to the limbs using inflatable garments. It simulates massage and aims to improve circulation and relieve muscle aches. This is a physical therapy or recovery device, not a diagnostic one.
Intended Use: The intended use clearly states "temporary relief of minor muscle aches and pains and for temporary increase in circulation." This is a therapeutic or recovery purpose, not a diagnostic one.
Device Description: The description details the mechanical operation of the inflatable garments and air chambers. There is no mention of analyzing biological samples.
Performance Studies: The performance studies listed are related to electrical safety, EMC, home healthcare environment requirements, and biocompatibility – all relevant for a physical medical device, but not for an IVD. There are no studies related to analyzing biological samples or diagnostic accuracy.

Therefore, based on the provided information, the Air Relax/Compressible Limb Sleeve System is a physical therapy or recovery device and does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

IRP

Device Description

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

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

Not Found

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)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including

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

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K182668, K193354

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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

March 5, 2021

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

Re: K191441

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

Dear Chris Park:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Heather L. Dean -S

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

Enclosure

510(k) Summary

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

The assigned 510(k) Number: K191441

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

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

1. Identification of Proposed Device

Regulatory Information

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

Intended Use Statement:

Device Description

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

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

Secondary Predicate device

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

న. Non-Clinical TestConclusion

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

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

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

No clinical study is included in this submission.

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

Device	Subject Device	Primary Predicate	Secondary Predicate	Comparison
Manufacturer	Maxstar Industrial Co.,
Ltd.	Rapid Reboot Recovery
Products, LLC	Shenzhen Dongjilian
Electronics Co., Ltd.	NA
510(k)
Number	Not yet	K182668	K193354	NA
Model Name	AR-1.0, AR-2.0	Rapid Reboot Compression
Therapy System	S9019	NA
Classification	Class II Device, IRP
(21 CFR890.5650)	Class II Device, IRP (21
CFR890.5650)	Class II Device, IRP
(21 CFR890.5650)	Same as all predicates.
Indications
for Use (IFU)	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
Model AR-1.0/AR-2.0
simulates kneading and	The Rapid Reboot Compression
Therapy System 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 Rapid Reboot
Compression Therapy System
simulates kneading and stroking of
tissues by using an inflatable
garment.	The Air Compression
Therapy Device is indicated
for the temporary relief of
minor muscle aches and pains
and for temporary increase in
circulation to the treated areas
in people who are in good
health. The Air Compression
Therapy Device simulates
kneading and stroking of
tissues by using an inflatable
garment	Same as K182668
(Primary predicate) and
K193354 (Secondary
predicate)
OTC or Rx	OTC	OTC	OTC	Same
Environment of Use:	Clinics, hospital, athlete
training, and home
environments	Clinics, hospital, athlete training,
and home environments	Clinics, hospital, athlete
training, and home environments	Same as K182668
(Primary predicate)
and K193354 (Secondary
predicate)
Standards	IEC 60601-1
IEC 60601-1-2
ISO 10993-5
ISO 10993-10
IEC 60601-1-11	IEC 60601-1
IEC 60601-1-2
ISO 10993-5
ISO 10993-10	IEC 60601-1
IEC 60601-1-2
ISO 10993-5
ISO 10993-10
IEC 60601-1-11	Same
Mode of
Compression	Sequential/Peristaltic	Sequential/Peristaltic	Sequential/Peristaltic	Same
Power Source	120 V, 60Hz	110 V, 60Hz	100-240V, 50/60Hz	Similar
Note 1
Therapy Time	Has 15 minute sessions.	User determines therapy time.
Choose from 10, 20, or 30 minute
session time, with option to add
additional 10 minutes to any therapy
time.	Has 20 minute sessions.	Similar with Primary
predicate.
Session time is less than
Secondary predicate
Note 2
Max Pressure
Min Pressure	0-230 mmHg	0-200 mmHg	0 to 240 mmHg	Lower than K193354
(Secondary predicates)
Little higher than K182668
(primary predicate)
Note 3
Number of
Chambers:	4 Chambers	4 Chambers	3 chambers	Same as Primary predicate
Compression
Applicator
Garments
Sleeve	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	Nylon with a Polyurethane
laminate	Same
Housing
Material
And
Construc
tions	Molded ABS enclosure
Orange: AR-1.0
Navy: AR-2.0	Molded ABS enclosure	Molded ABS enclosure	Same types of housing material
Patient
contact	Non-conductive attachments	Non-conductive attachments	Non-conductive attachments	Same
Power
Consum
ption	60VA	30W	12W	Similar as Primary and Secondary predicate
Note 4
Size and
photo	240 x 190 x 120/mm
Image: [device with white and orange top and black bottom]
Image: [black device]	10" x 6.5" x 5"
Image: [black device with green screen]	10.2 x 5.9 x 25.6 (in)
Image: [black device]	Similar with Primary predicate and secondary predicate
Note 5
Weight	2.3kg	5.8 pounds	4.6 pounds
Modes
(Inflation
sequences, all
preprogramme
d)
(visual
description)	3 mode
"A" mode inflates
and deflates chambers from
bottom up (distal to proximal
chambers), one at a time.
Image: [diagram of inflation sequence]
"B" mode also inflates chambers
from bottom up, but maintains
pressure in lower chambers as
works its way to top. Then all
chambers release pressure at same
time once all chambers have
sequentially inflated.
Image: [diagram of inflation sequence]
"C"mode is inflates all chambers
and maintained pressure at same
time and release pressure all
chambers.
Image: [diagram of inflation sequence]	2 modes:
"A" mode inflates and deflates
chambers from bottom up (distal to
proximal chambers), one at a time.
Image: [diagram of inflation sequence]
"B" mode also inflates chambers from
bottom up, but maintains pressure in
lower chambers as works its way to
top. Then all chambers release pressure
at same time once all chambers have
sequentially inflated
Image: [diagram of inflation sequence]	3 mode
Mode 1: Starting with the foot
chamber and progressing up the
thigh chamber, each section
compresses and the pressure
gradually rises to the pre-
determined air pressure level,
then decompresses.
Image: [diagram of inflation sequence]
Mode 2: Starting with the foot
chamber and progressing up the
thigh, each section compresses
and the pressure gradually rises
to the pre-determined air
pressure level, holds the air
until the entire garment is
compressed. All three sections
then decompress
simultaneously.
Mode 3: include two stage,
Image: [diagram of inflation sequence]
stage 1: it work according to the
method of mode 1, after the
stage 1 is completed, it go to
stage 2	Similar with Primary predicate
e and secondary predicate
Note 6
Image: [no image]
"Leg" Attachment	Leg (consisting of foot, calf,
knee, upper leg)	Leg (consisting of foot, calf, knee,
upper leg), Arm, Hip	Leg (consisting of foot and
calf).	Similar with Primary predic
ate and secondary predicate
Note 7
Leg Attachment
Sizes	Sleeve (L) : 320*740
(mm)
Sleeve (XL): 390*890
(mm)
Sleeve (XXL) :
390*990 (mm)	X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52"	Sleeve : 260x730
(mm)	Similar with Primary predic
ate and secondary predicate
Note 7
Safety Features	Button on display allows
user to stop or pause
therapy session at any time	Button on display allows user to
stop or pause therapy session at any
time.	Standby button allows
user to stop therapy
session at any time	Same
SW/Firmware
Microprocessor	Microprocessor	Microprocessor	Microprocessor	Same
Technology	Compressor and valve
system which sequentially
inflates cells of appliance	Compressor and valve system
which sequentially inflates cells of
appliance	Compressor and valve
system which sequentially
inflates cells of appliance	Same

510(k) Summary

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

Substantially Equivalent (SE) Conclusion

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

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

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