Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is standard for automated medical devices. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.

Therapeutic

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

Diagnostic

No

This device is described as providing temporary relief for muscle aches and increasing circulation through compression. It simulates kneading and stroking of tissues. There is no indication or description of it being used to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as an air pump, air pressure sensor, sleeves, hoses, and a microprocessor, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health." This describes a physical therapy or massage-like function, not a diagnostic test performed on biological samples.
Device Description: The device works by applying external pressure to the body using inflatable sleeves. It does not involve the analysis of blood, urine, tissue, or any other biological specimen.
Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other components or processes typically associated with in vitro diagnostics.

IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device 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

Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Low limbs (Foot, calf and upper leg)

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

A series of safety and performance tests were conducted on the subject device.

Product service life
Software validation
Electromagnetic compatibility and electrical safety
Function test

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

No clinical test data was used to support the decision of substantial equivalence.

All the test results demonstrate Air Compression Therapy Device meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.

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.

K182668, K030437, K160608

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

June 8, 2020

Shenzhen Dongjilian Electronics Co., Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. Room 2012#, Gebu commercial building, Hongxing community, Songgang street Shenzhen, 518105 Cn

Re: K193354

Trade/Device Name: Air Compression Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 28, 2020 Received: June 8, 2020

Dear Reanny Wang:

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 (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-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) K193354

Device Name Air Compression Therapy Device

Indications for Use (Describe)

The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

K193354

1. Information of Submitter and Correspondent

Submitter's information:

Company Name:	Shenzhen Dongjilian Electronics Co.,Ltd.
Street Address:	B1/1-5F, Tonglu Industrial Area, 70# Tongxin Road, Tongxin Community, Longgang District
City:	Shenzhen
State/ Province:	Guangdong
Country:	China
Telephone:	+86(755) 89964118
Fax:	+86(755) 89964008
Contact Person:	ZHANG HONG
Contact Title:	General Manager
Contact Email:	zh@dongjilian.com

Date Prepared: May 27, 2020

Submission correspondent's information:

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd

Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China
Contact Person: Reanny Wang

E-mail: reanny@reanny.com

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Image /page/4/Picture/0 description: The image shows the word "CINCON" in a stylized, bold font. The letters are primarily white with a black outline, giving them a three-dimensional appearance. The "O" in "CINCON" has a red fill, adding a touch of color to the otherwise monochrome design. A registered trademark symbol is present to the right of the word.

Phone: +86(755) 27391220

2. Device Information

Trade Name:	Air Compression Therapy Device
Model:	S9019
Common Name:	Powered Inflatable Tube Massager
Classification Name:	Massager, Powered Inflatable Tube
Regulation:	21 CFR § 890.5650
Device Class:	Class 2
Product Code:	IRP

3. Identification of Predicate Device(s)

| Manufacturer | Rapid Reboot Recovery
Products, LLC | Salton,INC | NormaTec
Industries, LP |
|----------------------------|-----------------------------------------------|--------------------------------------------------|------------------------------------------|
| Legally Marketed
Device | Rapid Reboot
Compression Therapy
System | Relaxor Perfect
Touch Air Massaging
System | NormaTec Pulse and
NormaTec Pulse Pro |
| 510(K) Number | K182668 | K030437 | K160608 |

4. Description of Device

Air Compression Therapy Device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 3 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

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Image /page/5/Picture/0 description: The image shows the Cincom logo. The logo is in black and white, with a red square in the middle of the "O". The logo is a stylized version of the word "CINCOM". There is a registered trademark symbol to the right of the logo.

Indications for Use 5.

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.

6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

6.1 Non-clinical testing

A series of safety and performance tests were conducted on the subject device.

Product service life
Software validation
Electromagnetic compatibility and electrical safety
Function test

All the test results demonstrate Air Compression Therapy Device meets the requirements of its pre-defined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.

6.2 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

7. Performance Summary

The devices conform to applicable standards as follow table:

| Test Type | Standard Designation
Number | FDA Recognition
Status | Outcome
for Device |
|-----------------------------|--------------------------------|---------------------------|-----------------------|
| Safety | ES 60601-1:2005+
A1:2012 | Yes | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms |
| Home healthcare environment | IEC 60601-1-11:2015 | Yes | Conforms |

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Image /page/6/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are outlined in white with a black fill, except for the letter "O", which has a red fill. A registered trademark symbol is located to the right of the word.

Performance	Enterprise standard	Yes	Conforms
Biocompatibility	ISO 10993-10:2010;
ISO 10993-5:2009	Yes	Conforms
Software	IEC 62304:2006/A1:2016	Yes	Conforms
Usability	IEC 60601-1-6:
2010+A1:2013
IEC 62366-1:2015	Yes	Conforms
Risk management	ISO 14971:2007	Yes	Conforms

8. Discussion of Comparison to Predicate Devices.

The Air Compression Therapy Device submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics/ principles of operation, materials, and performance to the cleared Rapid Reboot Compression Therapy System K182668, Relaxor Perfect Touch Air Massaging System K030437, and NormaTec Pulse and NormaTec Pulse Pro K160608. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.

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Image /page/7/Picture/0 description: The image contains the word "CINCOM" in a stylized, bold font. The letter "O" in "CINCOM" has a red square in the middle. There is a horizontal line below the word, and a registered trademark symbol is located to the right of the word.

Device	Subject device	Primary Predicate device	Secondary Predicate device	Third Predicate device	Comparison
Manufacturer	Shenzhen Dongjilian Electronics Co.,Ltd.	Rapid Reboot Recovery Products, LLC	Salton, Inc	NormaTec Industries, LP	NA
510(K) number	K193354	K182668	K030437	K160608	NA
Model name	S9019	Rapid Reboot Compression Therapy System	Relaxor Perfect Touch Air Massaging System	NormaTec Pulse and NormaTec Pulse Pro	NA
Classification	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Same
Indications for Use (IFU)	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.	The Rapid Reboot Compression Therapy System is indicated 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 Perfect Touch Air Massaging 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 Perfect Touch simulates kneading and stroking of tissues by using an inflatable garment.	The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.	Same
Treatment area/Structure of Sleeves	Low limbs (Foot, calf and upper leg)	Leg (including of foot, calf, knee, upper leg);
Hip (including of upper legs, glutes, hips, lower back);
Arm (including of entire arm, shoulder, upper chest and back)	Leg (including of foot, calf);
Back (including of lower and mid back);
Arm (including of forearm, lower bicep)	Leg (including of foot, calf, knee, upper leg);
Hip (including of upper legs, glutes, hips, lower back);
Arm (including of entire arm, shoulder	Same
Device	Subject device	Primary Predicate
device	Secondary Predicate
device	Third Predicate
device	Comparison
OTC or Rx	OTC	OTC	OTC	OTC
(upper chest and
back).	Same
Environment of
Use:	Clinics, hospital,
athlete training, and
home environments	Clinics, hospital, athlete
training, and home
environments	Home environment	Clinics, hospital,
athlete
training, and home
environments	Same
Power source	100~240V 50/60Hz	110V, 60HZ	120V, 60Hz	100- 240 VAC input	Same
Power
Consumption	12W	30W	26W	14W	Similar
Note 3
SW/Firmware/
Microprocesso
r Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Same
Therapy Time	20 minutes	User determines
therapy time. Choose
from 10, 20, or 30
minute session time,
with option to add
additional 10 minutes to
any therapy time.	15 minutes	User controlled 10
minutes to 175
minutes or continuous

total
time over 4
segments | Similar
Note 1 |
| Output
pressure range | 0240 mmHg | 0200 mmHg | 80 to 250 mmHg | 30-110 mmHg | Similar
Note 2 |
| Air pressure
level
/Compression
levels | 3 levels settings:
low level:150mmHg;
Mid level:185mmHg;
High Level: 215mmHg | Not publicly available | Not publicly available | Not publicly available | Not publicly available |
| Pressure error
range | $\pm$ 25mmHg | Not publicly available | Not publicly available | Unknown | Not publicly available |
| Inflation time | 3-30s | Not publicly available | Not publicly available | Not publicly available | Similar |
| Keep time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Note 11 |
| Deflation time | 1-5s | Not publicly available | Not publicly available | Not publicly available | Same |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Sequential/ Peristaltic | Same |
| Cycle time | Range of 25 sec to 3 | Not publicly available | Not publicly available | Not publicly available | Similar |
| Device | Subject device | Primary Predicate
device | Secondary Predicate
device | Third Predicate
device | Comparison |
| | min 40 sec | | | | Note 4 |
| Number of
chambers | 3 Chambers | 4 Chambers | 12 Chambers | 4 Chambers | Similar
Note 7 |
| Number of
treatment
mode | 3 modes | 2 modes | 1 mode | 2 modes | Similar
Note 6 |
| Modes (visual
description) | 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 and the
air pressure drops.
Once the thigh section
decompresses, the
cycle begins again.
Mode 1 follows this
pressure sequence:

Image: Mode 1 pressure sequence

Mode 2:
Starting with the foot
chamber and
progressing up the
thigh, each section | Mode A:
Starting with the distal
chamber and
progressing up the
proximal chamber, each
section compresses and
the pressure gradually
rises to the pre-
determined air pressure
level, then
decompresses and the
air pressure drops. Once
the top section
decompresses, the cycle
begins again.
Mode A follows this
pressure sequence:

Image: Mode A pressure sequence

Mode B:
Starting with the distal | Starting with the distal
chamber and
progressing up the
proximal chamber,
each section
compresses and the
pressure gradually
rises to the pre-
determined air
pressure level, then
decompresses and the
air pressure drops.
Operating until the top
section decompresses,
the cycle begins again.
Only has one mode. Follows
this sequence:

Image: Secondary Predicate device pressure sequence | Sequential mode:
Starting with the distal
chamber and
progressing up the
proximal chamber, each
section compresses
and the pressure
gradually rises to the
pre-determined air
pressure level, then
decompresses and the
air pressure drops.
Once the top section
decompresses, the
cycle begins again.
Again.
"Sequential:"

Image: Sequential mode pressure sequence

Normatec Pulse | Same |
| Device | Subject device | Primary Predicate device | Secondary Predicate device | Third Predicate device | Comparison |
| | 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 and the
air pressure drops, then
cycle begins again.
Mode 2 follows this
pressure sequence:
Image: Mode 2 pressure sequence | chamber and
progressing up the
proximal chamber, each
section compresses and
the pressure gradually
rises to the pre-
determined air pressure
level, holds the air until
the entire boot is
compressed. All four
sections then
decompress
simultaneously and the
air pressure drops, then
cycle begins again.
Mode B follows this
pressure sequence:
Image: Mode B pressure sequence | | mode:
Starting with the distal
zone and progressing
up the proximal zone,
one zone compresses
and the pressure
gradually rises to the
pre-determined air
pressure level, holds
the air of previous
two zone , the other
zones do not hold, until
the last zone finished,
deflate the all last three
zone then enter into
next cycle.
"Pulse Massage Pattern:"
Image: Pulse Massage Pattern | |
| | Mode 3:
include two stage, stage
1: it work according to
the method of mode 1,
after the stage 1 is
completed, it go to
stage 2(working
according to the method
of mode 2) without
interruption time until
finish the stage 2, then
enter next cycle without
interruption .
Mode1 Mode2
The pressure sequence | | | | |
| Device | Subject device | Primary Predicate
device | Secondary Predicate
device | Third Predicate
device | Comparison |
| | of mode 3 combines
mode 1 and mode 2 | | | | |
| Noise level | ≤ 65dB | Not publicly available | Not publicly available | Not publicly available | Similar
Note 9 |
| Sleeve
Material | Nylon with a
Polyurethane laminate | Nylon with a
Polyurethane laminate | Nylon with a
Polyurethane
laminate | Nylon with a
polyurethane
laminate | Same |
| Housing
Materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS
enclosure | Molded ABS
enclosure | Same |
| Patient contact | Non-conductive
attachments | Non-conductive
attachments | Non-conductive
attachments | Non-conductive
attachments | Same |
| Size and
appearance | $10.2 \times 5.9 \times 25.6$
(in )
Image: Subject device | 10" x 6.5" x 5"
Image: Primary Predicate device | 9" x 6" x 6"
Image: Secondary Predicate device | 4" x 5" x 9"
Image: Third Predicate device | Different
Note 5 |
| Weight | 4.6 pounds | 5.8 pounds | 3.2 pounds | 3.6 pounds | |
| Size and
appearance of
sleeves (leg
part) | Leg:
Image: Subject device sleeves | Leg:
Image: Primary Predicate device sleeves | Leg:
One size: 10" x 22"
Image: Secondary Predicate device sleeves | Leg:
Short: 14" x 43"
Standard: 14" x 48"
Tall: 14" x 60"
Image: Third Predicate device sleeves | Similar
Note 8 |
| Device | Subject device | Primary Predicate
device | Secondary Predicate
device | Third Predicate
device | Comparison |
| | One size: 73*26cm | X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52" | | | |
| Safety
Features | Standby button allows
user to stop therapy
session at any time | 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 | Button on display
allows user to stop or
pause therapy
session at any time. | Same |
| Operating
environment | Temperature: 5°C-
40°C, Humidity:5%-
90% non-condensing | Not publicly available | Not publicly available | Not publicly available | Similar
Note 10 |
| Transportation
&
Storage
environment | Temperature:
20°C~55°C;
Humidity:5%-90% non-
condensing
Atmospheric
Pressure:75kPa-
106kPa | Not publicly available | Not publicly available | Not publicly available | |
| Standards | ES 60601-1;
IEC60601-1-2;
ISO 10993-5;
ISO 10993-10;
IEC 60601-1-11 | IEC 60601-1;
IEC60601-1-2; ISO
10993-5: ISO 10993-10 | Not available | IEC 60601-1;
IEC 60601-1-2;
ISO 10993-5;
ISO 10993-10;
IEC 60601-1-11 | Same |

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Image /page/8/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are white with black outlines, and there is a small red square inside the "O". There is a horizontal line underneath the word, and a registered trademark symbol is located to the right of the word.

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Image /page/9/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are white with a black outline, and the "O" is red. There is a horizontal line underneath the word, and a registered trademark symbol is to the right of the word.

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Image /page/10/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are white with a black outline, and the "O" is red. There is a horizontal line underneath the word, and a registered trademark symbol is to the right of the word.

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Image /page/11/Picture/0 description: The image contains the word "CINCOM" in a stylized, bold font. The letter "O" in "CINCOM" has a red square in the middle. There is a horizontal line below the word, and a registered trademark symbol is located to the right of the word.

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Image /page/12/Picture/0 description: The image shows the word "CINCOM" in a stylized font. The letters are white with a black outline, and the "O" is red. There is a horizontal line underneath the word, and a registered trademark symbol is to the right of the word.

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Similarity and Difference

The Air Compression Therapy Device S9019 has been compared with Rapid Reboot Compression Therapy System (K182668), Relaxor Perfect Touch Air Massaging System (K030437) and NormaTec Pulse and NormaTec Pulse Pro (K160608). 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. 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.

Note 1: Although the treatment time of subject device is different the predicate device, but the treatment time of subject device was within the range of predicated device, so the small differences do not affect the safety and effectiveness.

Note 2: Although the "Output pressure range" of the subject device is different from that of the predicate devices, but the minimum air pressure (0mmHg) of subject device is the same as the predicate device 1, the maximum air pressure of subject device (240mmHg) is within the output pressure range of the predicate device 2 (80 to 250 mmHg), in general, the output pressure range of subject device is within the range of those predicate devices. Additionally, the subject device was conforms to ANSI/AAMI ES60601-1 and ISO 14971, so the small differences do not affect the safety and effectiveness. Although the "air pressure level /compression levels" of subject device is different to the predicate devices, but they output air pressure range are similar, so the pressure level different do not affect the safety and effectiveness. Although we don't know the pressure error of predicated device, but due to their "output pressure range" are similar, so this item does not affect the safety and effectiveness.

Note 3: Although the "power consumption" of the subject device is different than the predicate devices, they both use a power adaptor and the adaptor both comply with ANSI/AAMI ES60601-1, so the difference does not affect the safety and effectiveness.

Note 4: Although the "Cycle time" of subject device is different the predicate devices, but the range of cycle time was between the predicate 3 (maximum value) and predicate device 2 (minimum value), so the small difference do not affect the safety and effectiveness.

Note 5: Although the "Size and appearance" and "Weight" between the predicate devices and subject device are different, they are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness.

Note 6: Although the "Number of treatment mode" is different the predicate device, the "Indications for Use", "Principles of operations" and "Modes (visual description)" are same, so these differences do not affect the safety and effectiveness.

Note 7: Although the "Number of chambers" of subject device is different to the predicated device,

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but due to the chamber number only determines the applicable treatment site, while the "applicable treatment site" and "Indications for Use" of subject device is within the range of predicated device, so the differences do not affect the safety and effectiveness.

Note 8: The "Size and appearance of sleeves (leq part)" of subject device is different the predicate device, because their chamber and applicable treatment site is different. Based the analysis as the NOTE 7, we know: although the "Size and appearance of sleeves (leq part)" between the predicate devices and subject device is different, but the "applicable treatment site" and "Indications for Use" of subject device is within the range of predicated device, so the differences do not affect the safety and effectiveness.

Note 9: Although the "Noise level" of predicate devices are unknown, but there are both had passed the ANSI/AAMI ES60601-1 and ISO 14971 standards, so the difference do not affect safety or effectiveness issue.

Note 10: Although the "Operating environment" and "Transportation & Storage environment" of subject devices are different to the predicate devices, but they are both compliance with the ANSI/AAMI ES60601-1 and IEC 60601-1-11 standards, so the small difference will not affect the safety or effectiveness issue.

Note 11: Although the predicate device does not disclosure the inflation time, it is not possible to directly determine the substantially equivalent between the subject device and predicate device. For the safety: the subject device has compliance with IEC 60601-1 and ISO 14971 standards. And the subject device has designed the pressure sensor to protection the overpressure, so the subject device was safety. For the effectiveness: since the treatment mode, treatment pressure and cycle time of the subject device is similar to the predicate devices, so we can be considered that the subject device and predicate device had similar effectiveness. Based on the above analysis, can be considered the small difference will not affect the safety or effectiveness issue.

9. Conclusions

The subject device has same intended use, principle of operation, and technological characteristics as the predicate devices. Although there are several specifications that are different between these devices, testing and discussion 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 conformed with the test requests. Therefore, the differences between the subject device and the predicate devices do not raise any concerns with respect to substantial equivalence. The subject device is substantially equivalent to the predicate devices and the differences in technological characteristics do not raise different questions of safety and effectiveness based on the testing submitted to support this submission.