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K Number
K220572
Device Name
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
Manufacturer
CERAGEM Co, Ltd.
Date Cleared
2022-06-17

(109 days)

Product Code
JFBIRP
Regulation Number
890.5880
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for: -Temporary relief of minor muscle and joint pain stiffness -Temporary relief of minor joint pain associated with arthritis -Temporary increase in local circulation where applied - Relaxation of muscles The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.
Device Description
The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager 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 4 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 cognized to the sensor, cycling airflow into and out of sleeves to compress body.
More Information

K202937

K193354

No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is standard automation, not AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.

Yes
The device is intended to provide muscle relaxation therapy and temporary relief of minor muscle and joint pain, stiffness, and pain associated with arthritis, as well as temporarily increase local circulation and blood circulation. These are therapeutic uses.

No

The device is described as providing muscle relaxation therapy, temporary pain relief, increased circulation, and muscle relaxation through heat and massage, not for diagnosing medical conditions.

No

The device description explicitly details hardware components like an air pump, air pressure sensor, sleeves, hoses, and a microprocessor, which are integral to its function. While software controls the timing and pressure, it is clearly part of a larger hardware system.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description of the Ceragem Automatic Thermal Massager clearly states its function is to provide muscle relaxation therapy, deliver heat and massage, and provide topical radiant infrared heat and air compression for pain relief and circulation. These are all external, physical therapies applied to the body.
  • No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.

The device is a therapeutic massager, not a diagnostic tool that analyzes samples.

N/A

Intended Use / Indications for Use

The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

-Temporary relief of minor muscle and joint pain stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied

  • Relaxation of muscles

The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.

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

JFB, IRP

Device Description

The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature.

This feature utilizes an "air compression transfer," and its principle is as follows:

Air Cell Massager 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 4 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 cognized to the sensor, cycling airflow into and out of 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

Home Use
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)

  • Skin Temperature Study
  • The usability study was performed to validate that the lay users can use the subject device only with the User Manual provided.
  • The EMC and electrical safety testing were conducted on the subject device in accordance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11 to demonstrate the safety and effectiveness.
  • The level of concern for the subject device's software is moderate and the validation tests were performed to verify that the firmware works as intended. The test results support that the subject device is substantially equivalent to the predicate device.
  • Biocompatibility studies were performed to evaluate the safety of the new materials which comes in contact with the patients in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows, and the results satisfied the ISO standards requirements.
    • Cytotoxicity Test per ISO 10993-5:2009 -
    • Sensitization per ISO 10993-10:2010 -
    • Irritation Test per ISO 10993-10:2010 -

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.

K202937

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.

K193354

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

§ 890.5880 Multi-function physical therapy table.

(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).

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June 17, 2022

CERAGEM Co. Ltd. % Joyce Kwon CEO Provision Consulting Group, Inc. 100 Barranca St. Suite 700 West Covina, California 91791

Re: K220572

Trade/Device Name: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB, IRP Dated: May 16, 2022 Received: May 19, 2022

Dear Joyce Kwon:

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.

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

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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,

Amber Ballard, PhD Assistant 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) K220572

Device Name

Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702

Indications for Use (Describe)

The intended use of the Ceragem Automatic Thermal Massager,

Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

-Temporary relief of minor muscle and joint pain stiffness

-Temporary relief of minor joint pain associated with arthritis

  • -Temporary increase in local circulation where applied
  • Relaxation of muscles

The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading 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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Image /page/3/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized green bird with its wings spread, facing left. To the right of the bird is the word "PROVISION" in bold, followed by "CONSULTING GROUP" in a smaller font size underneath. The logo has a clean and professional design.

510(k) Summary

510(k) Submitter

Hyeonggeun Hwang CERAGEM Co, Ltd. 10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, Chungcheongnam-do 31041 Republic of Korea

Official Correspondent / Contact Person

Joyce Kwon, CEO/Principal Consultant Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 +1-909-493-3276 joyce@provisionfda.com

Date Prepared

June 17, 2022

Device Information

  • Trade Name: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 .
  • . Common Name: Physical Therapy Table
  • Classification Name: Multi-function physical therapy table .
  • . Regulation Number: 21 CFR 890.5880
  • Device Class: Class II .
  • . Product Code: JFB, IRP
  • . 510(k) Identification Number: K220572

Primary Predicate Devices

Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702, K202937 The predicate has not been subject to a design-related recall.

Reference Device:

  • Air Compression Therapy Device, K193354 .

Prior Submission Information

None

Indication for Use

The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:

  • Temporary relief of minor muscle and joint pain stiffness
  • Temporary relief of minor joint pain associated with arthritis
  • Temporary increase in local circulation where applied

4

Image /page/4/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings on the left side. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, and below that is "CONSULTING GROUP" in a smaller font.

  • Relaxation of muscles
    The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.

Device Description

The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature.

This feature utilizes an "air compression transfer," and its principle is as follows:

Air Cell Massager 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 4 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 cognized to the sensor, cycling airflow into and out of sleeves to compress body.

5

Image /page/5/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings in a muted green color. To the right of the bird is the company name, "PROVISION," in a larger, bolder font, with the words "CONSULTING GROUP" underneath in a smaller font.

Substantial Equivalent Comparison Chart with Primary Predicate Device

Subject DevicePrimary Predicate DeviceComparison
Device NameCeragem Automatic Thermal Massager,
Model CGM MB-1701 & CGM MB-1702Ceragem Automatic Thermal Massager,
Model CGM MB-1701&
CGM MB-1702
ManufacturerCeragem International, Inc.Ceragem International, Inc.
510(k) NumberK220572K202937
Regulation Number21 CFR 890.5880,
21 CFR 890.565021 CFR 890.5880N/A
Product CodeJFB, IRPJFB
Indications for Use
(IFU)The intended use of the Ceragem Automatic
Thermal Massager,
Model CGM MB-1701 & CGM MB-1702 is to
provide muscle relaxation therapy by delivering
heat and soothing massage. Additionally, the
product provides topical radiant infrared heat
for:
-Temporary relief of minor muscle and joint
pain stiffness
-Temporary relief of minor joint pain associated
with arthritis
-Temporary increase in local circulation where
applied
  • Relaxation of muscles
    The Air Cell Massager (only CGM MB-1701) is
    indicated for the temporary relief of minor
    muscle aches and pains and for temporary
    increase in blood circulation to the treated areas.
    The Air Cell Massager stimulates kneading and
    stroking of tissues by using an inflatable
    garment. | The intended use of the Ceragem Automatic
    Thermal Massager,
    Model CGM MB-1701 & CGM MB-1702
    is to provide muscle relaxation therapy by
    delivering heat and soothing massage.
    Additionally, the product provides topical
    radiant infrared heat for:
  • Temporary relief of minor muscle and
    joint pain stiffness
  • Temporary relief of minor joint pain
    associated with arthritis
  • Temporary increase in local circulation
    where applied
  • Relaxation of muscles | Similar | |
    | Rated Voltage | 100-127Vac 50/60Hz | 100-127Vac 50/60Hz | Same | |
    | | Home Use | Yes | Yes | |
    | | Style | Flood Model (Massage Bed) | Flood Model (Massage Bed) | |
    | | Components | Main Table | Main Table | Same |
    | | | Supporting Mat | Supporting Mat | |
    | | | Remote Control | Remote Control | |
    | | | 3-Sphere projector | 3-Sphere projector | |
    | | | Abdominal Vibration Projector | Abdominal Vibration Projector | |
    | | Components | Power cord | Power cord | |
    | | | Outer fabric | Outer fabric | |
    | | | Head cushion | Head cushion | |
    | | | Projector Cover | Projector Cover | |
    | | | Air Cell Massager | Calf Massager | Different
    (Note 1) |
    | | Remote Control | Yes | Yes | |
    | | Operation Method | Auto / Manual | Auto / Manual | |
    | | Infrared Emission
    Spectrum | Ceramic: 520
    Epoxy Carbon Panel: 5    20 | Ceramic: 520
    Epoxy Carbon Panel: 5    20 | |
    | Heating
    Device | Voltage | 24V | 24V | |
    | | Power | 28.8W | 28.8W | |
    | | Temperature Range | Internal: 30°C - 65°C (86°F - 149°F)
    External, Main, Auxiliary: 30°C - 60°C (86°F -
    140°F) | Internal: 30°C - 65°C (86°F - 149°F)
    External, Main, Auxiliary: 30°C - 60°C (86°F -
    140°F) | |
    | | Distance of the Internal
    Projector | 710mm | 710mm | |
    | | Intensity Level | 19
    (12.9    69.2mm) | 19
    (12.9    69.2mm) | |
    | | Extra Overheating
    Protection | Yes | Yes | |
    | | Moving Device | Geared DC Motor | Geared DC Motor | |
    | | Limit Detector | Limit Switch | Limit Switch | |
    | | Temperature Sensor | Thermistor | Thermistor | Same |
    | | Control Method | Microcontroller | Microcontroller | |
    | | Tugging Method | Wire-Chain | Wire-Chain | |
    | Material | Main/Supporting Frame | Steel, ABS | Steel, ABS | |
    | | Outer Fabric | Polyester, Cotton, Rayon, Polyurethane | Polyester, Cotton, Rayon, Polyurethane | |
    | | Main Mat/Supporting Mat | Nylon
    Polyurethane | Nylon
    Polyurethane | |
    | | | | | |
    | Projectors | Internal Projector | Ceramic Rollers | Ceramic Rollers | |
    | | External Projector | Ceramic Heads Projector | Ceramic Heads Projector | |
    | Mat Dimensions | | • When spread out:
    : 728.2mm x 2012.4mm x 431.5mm (±5mm)
    • When folded:
    : 728.2mm x 2044mm x 431.5mm (±5mm) | • When spread out:
    : 728.2mm x 2012.4mm x 431.5mm (±5mm)
    • When folded:
    : 728.2mm x 2044mm x 431.5mm (±5mm) | |
    | | Weight | Weight: 62kg for CGM MB-1701,
    57kg for CGM MB-1702 | Weight: 62kg for CGM MB-1701,
    57kg for CGM MB-1702 | |
    | | Mode | Mode A | Mode A | |
    | | | Mode 1 | Mode 1 | |
    | | | Mode 2 | Mode 2 | |
    | | | Mode 3 | Mode 3 | |
    | | | Mode 4 | Mode 4 | |
    | | | Mode 5 | Mode 5 | |

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Image /page/6/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird made of overlapping green shapes. To the right of the bird is the word "PROVISION" in bold, followed by "CONSULTING GROUP" in a smaller font size.

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Image /page/7/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings in a teal color. To the right of the bird is the text "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font size underneath.

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Image /page/8/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with several wing feathers on the left. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath.

Mode 6Mode 6
Mode 7Mode 7
Mode 8Mode 8
Mode 9Mode 9
Mode 10Mode 10
Mode 11Mode 11
Mode 12Mode 12
Mode 13Mode 13
Mode 14Mode 14
Mode 15Mode 15
Mode 16N/A
Intensive ModeIntensive Mode
Semi-Automatic ModeSemi-Automatic Mode
Semi-Automatic Master ModeSemi-Automatic Master Mode
Manual ModeManual Mode
Manual Master ModeManual Master Mode
Abdominal Vibration Projector ModeAbdominal Vibration Projector Mode
Air Massage ModeCalf ModeDifferent
(Note 1)

Substantial Equivalent Comparison Chart with Reference Device

Subject DeviceReference DeviceComparison
Device NameCeragem Automatic Thermal Massager, Model
CGM MB-1701 & CGM MB-1702Air Compression Therapy Device
ManufacturerCeragem International, Inc.Shenzhen Dongjiilian Electronics Co., Ltd.N/A

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Image /page/9/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings on the left. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath.

510(k) NumberK220572K193354
Regulation Number21 CFR 890.5880,
21 CFR 890.565021 CFR 890.5650N/A
Product CodeJFB, IRPIRP
Indications for Use (IFU)The intended use of the Ceragem Automatic
Thermal Massager,
Model CGM MB-1701 & CGM MB-1702 is to
provide muscle relaxation therapy by
delivering heat and soothing massage.
Additionally, the product provides topical
radiant infrared heat for:
-Temporary relief of minor muscle and joint
pain stiffness
-Temporary relief of minor joint pain
associated with arthritis
-Temporary increase in local circulation where
applied
  • Relaxation of muscles
    The Air Cell Massager (only CGM MB-1701)
    is indicated for the temporary relief of minor
    muscle aches and pains and for temporary
    increase in blood circulation to the treated
    areas. The Air Cell Massager stimulates
    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. | Similar |
    | Treatment area/Structure
    of Sleeves | Low limbs
    (Foot, calf and upper leg) | Low limbs
    (Foot, calf and upper leg) | |
    | OTC or Rx | OTC | OTC | Same |
    | Environment of Use | Clinics, hospital, athlete training, and home
    environments | Clinics, hospital, athlete training, and home
    environments | |
    | Power source | 100-127Vac 50/60Hz | 100240V 50/60Hz | Similar |
    | Power Consumption | 480VA | 12W | Different
    (Note 2) |
    | SW/Firmware/
    Microprocessor Control | Microprocessor | Microprocessor | Same |
    | Output pressure range | 48    240 mmHg | 0240 mmHg | Same |
    | Air pressure
    level/Compression levels | 9 levels settings:
    Level 1 : 48mmHg
    Level 2 : 72mmHg
    Level 3 : 96mmHg
    Level 4 : 120mmHg
    Level 5 : 144mmHg
    Level 6 : 168mmHg
    Level 7 : 192mmHg
    Level 8 : 216mmHg
    Level 9 : 240mmHg | 3 levels settings:
    low level: 150mmHg,
    Mid-level: 185mmHg,
    High Level: 215mmHg
    (± 25mmHg) | Different
    (Note 3) |
    | Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Same |
    | Inflation time | 1min    1min 30s | 3-30s | Different
    (Note 4) |
    | Therapy Time | 18 minutes | 20 minutes | |
    | Keep time | 113s | 1-5s | |
    | Deflation time | 1    10s | 1-5s | |
    | Cycle time | Range of 28 sec to 39sec | Range of 25 sec to 3 min 40 sec | |
    | Number of chambers | 4 Chambers | 3 Chambers | |
    | Number of treatment
    mode | 3 modes | 3 modes | Same |
    | Modes (visual
    description) | Image: Diagram of chambers numbered 1, 2, 3, and 4.
    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 | 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 | Different
    (Note 5) |

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Image /page/10/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized image of a bird with several wing feathers. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath.

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Image /page/11/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird with outstretched wings in a teal color. To the right of the bird is the word "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font underneath. The overall design is clean and professional.

decompresses and the air pressure drops. Once the thigh section decompresses, the cycle begins again.

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 four sections then decompress simultaneously, and the air pressure drops, then cycle begins again.

Mode 3:

Start between the foot chamber to the thigh chamber except for No. 4 chamber. And No.4 chamber is compressed while the other chambers are maintained. After that all four sections decompress simultaneously and the air pressure drops, then cycle begins again. This sequence is similar to the Mode 2.

this pressure sequence:

Image /page/11/Picture/7 description: The image shows a diagram of a leg with a compression device wrapped around it. The device appears to be inflating in sections, starting from the ankle and moving up the leg. There are three different stages of inflation shown in the diagram. The arrows indicate the direction of blood flow.

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, and the air pressure drops, then cycle begin again. Mode 2 follows this pressure sequence:

Image /page/11/Picture/10 description: The image shows a diagram of a biological process, possibly related to cell division or movement. It depicts three stages of a process where a structure, outlined in dark blue, changes shape. The structure appears to elongate and contract, with internal elements moving within it, indicated by pink arrows.

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 ** Mode 2

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| | | The pressure sequence of mode 3 combines
mode 1 and mode 2 | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------|
| Sleeve Material | Oxford and Nylon | Nylon with a Polyurethane laminate | Similar |
| Patient contact | Non-conductive attachments | Non-conductive attachments | Same |
| Size and appearance of
sleeves (leg part) | Leg:
Image: Leg sleeves
One size: 2858.4cm | Leg:
Image: Leg sleeves
One size: 7326cm | |
| Safety Features | Power On/off and mode start/pause button
allows user to stop therapy session at any time | Standby button allows user to stop therapy
session at any time | Different
(Note 6) |
| Transportation & Storage
environment | Temperature: -20°C to 60°C
Humidity: 10% to 95%
Atmospheric pressure: 500hPa -1060hPa | Temperature: -20°C55°C
Humidity: 5%-90% noncondensing
Atmospheric Pressure:75kPa106kPa | |
| Standards | ANSI AAMI ES60601-1:2005/®2012 and
A1:2012, C1:2009/®2012
IEC 60601-1-2 Edition 4.0
IEC 60601-1-6 Edition 3.1
IEC 60601-1-11 Edition 2.0
ISO 10993-5 Third edition
ISO 10993-10 Third Edition | ES 60601-1;
IEC60601-1-2;
ISO 10993-5:
ISO 10993-10;
IEC 60601-1-11 | |

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Substantial Equivalence Discussion

The subject device is an upgraded version of the predicate device that features "Air Cell Massage" which allows users to stimulate leg tissues by kneading and stroking by wearing an inflatable garment. The key differences of the two devices are:

Note 1: The design change is simply an exterior change that does not impact the efficacy or safety of the device.

Note 2: 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 3:

The air pressure/compression levels of the subject are divided into 9 levels whereas the predicate device's air pressure levels are divided into 3 levels. The minimum pressure level of the subject is significantly lower than the predicate and the maximum pressure level is same as the predicates, so there is no safety issue concerned and as for the efficacy, it remains valid since its performance has been demonstrated by the performance testing data included in this submission.

Note 4:

  • Inflation time: Inflation times are slightly different but there are no safety or efficacy issues because it just requires more time to inflate one more chamber.
  • · Therapy Time: Therapy time of subject device is 2 minutes less than the predicate's and such difference does not raise any safety or efficacy issues.
  • · Keep time: Keep times are slightly different but there are no safety or efficacy issues it just requires more time to keep on for one more chamber.
  • · Deflation time: Deflation times are slightly different but there are no safety or efficacy issues because it just requires more time to deflate one more chamber.
  • · Cycle time: Although the cycle time of subject device is different the predicate devices, but the range of cycle time falls under the predicate's, so such difference does not affect the safety and effectiveness.
  • · Number of chambers: Although the number of chambers of subject device is different to the predicated device (one more chamber for subject device), due to the chamber 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 5: While both devices are comprised of three modes of treating for the same treatment areas foot, calve and thigh, - the only difference is the sequence in which the air pressure is provided to each treatment area. Therefore, there are no significant efficacy or safety issues raised.

Note 6:

  • · Size and appearance of sleeves (leg part): Slight differences of size and appearance of the sleeves do not raise any safety or efficacy issues.
  • · Safety Features: They are just different types of the features, and both will be effective to function as safety features, thus such difference does not raise any safety or efficacy issues.
  • · Transportation & Storage environment: Such difference does not raise any safety or efficacy issues.
  • · Standards: Such difference does not raise any safety or efficacy issues.

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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 the two 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. 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.

Non-Clinical Test Data

The following data were provided in support of the substantial equivalence determination.

  • . Skin Temperature Study
  • . The usability study was performed to validate that the lay users can use the subject device only with the User Manual provided.
  • . The EMC and electrical safety testing were conducted on the subject device in accordance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11 to demonstrate the safety and effectiveness.
  • . The level of concern for the subject device's software is moderate and the validation tests were performed to verify that the firmware works as intended. The test results support that the subject device is substantially equivalent to the predicate device.
  • . Biocompatibility studies were performed to evaluate the safety of the new materials which comes in contact with the patients in accordance with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued in 2016 and ISO 10993 standards as follows, and the results satisfied the ISO standards requirements.
    • Cytotoxicity Test per ISO 10993-5:2009 -
    • Sensitization per ISO 10993-10:2010 -
    • Irritation Test per ISO 10993-10:2010 -

Electrical safety and electromagnetic compatibility (EMC)

The EMC and electrical safety testing were conducted on the subject device in accordance with the following standards.

  • ANSIAAMIES60601−1:2005/ ⑧2012 and A1:2012, C1:2009/ 82012 .
  • . IEC 60601-1-2 Edition 4.0
  • IEC 60601-1-6 Edition 3.1 .
  • IEC 60601-1-11 Edition 2.0 .

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  • ISO 10993-5 Third edition .
  • ISO 10993-10 Third Edition •

Software Verification and Validation Testing

Software validation activities have been conducted and the reports were prepared in accordance with "FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The level of concern was determined "Moderate".

Conclusions

The subject device is substantially equivalent in intended use, technological characteristics/ principles of operation, materials, and performance to the predicate device and the differences between the subject and predicate devices do not raise new questions of safety and effectiveness.