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

K220572 · Ceragem Co., Ltd. · JFB · Jun 17, 2022 · Physical Medicine

Device Facts

• Record ID: K220572
• Device Name: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
• Applicant: Ceragem Co., Ltd.
• Product Code: JFB · Physical Medicine
• Decision Date: Jun 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Ceragem Automatic Thermal Massager is a multi-function physical therapy table for home use. It delivers heat and massage via internal ceramic rollers and external projectors. The CGM MB-1701 model includes an integrated Air Cell Massager for leg therapy. The Air Cell Massager uses an air pump, pressure sensors, and inflatable sleeves with 4 compression chambers to provide sequential or peristaltic kneading and stroking of tissues from foot to thigh. A microprocessor controls inflation/deflation cycles and pressure levels. Users operate the device via a remote control to select modes and adjust settings. The device provides radiant infrared heat and mechanical massage to promote muscle relaxation and local circulation. Benefits include temporary pain relief and improved circulation. The system includes safety features like overheating protection and emergency stop buttons.

Clinical Evidence

Bench testing only. Includes skin temperature study, usability study for lay users, electrical safety and EMC testing (ANSI/AAMI ES60601-1, IEC 60601-1-2/6/11), and biocompatibility testing (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Multi-function physical therapy table. Materials: Steel, ABS frame; Polyester/Cotton/Rayon/PU fabric; Nylon/PU sleeves. Energy: 100-127Vac, 50/60Hz. Sensing: Thermistor (temperature), air pressure sensor. Actuation: Geared DC motor (rollers), air pump (compression). Connectivity: Standalone. Software: Microcontroller-based. Sterilization: N/A. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2/6/11, ISO 10993-5/10.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle and joint pain, stiffness, and arthritis-associated joint pain, and for temporary increase in local circulation. The Air Cell Massager (CGM MB-1701) is indicated for temporary relief of minor muscle aches and pains and increased circulation in treated areas.

Regulatory Classification

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.

Predicate Devices

• Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM MB-1702 (K202937)

Reference Devices

• Air Compression Therapy Device (K193354)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [phone] [e-mail]

# 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

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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.

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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 Device | Primary Predicate Device | Comparison | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------|
| Device Name | Ceragem Automatic Thermal Massager,<br>Model CGM MB-1701 & CGM MB-1702 | Ceragem Automatic Thermal Massager,<br>Model CGM MB-1701&<br>CGM MB-1702 | | |
| Manufacturer | Ceragem International, Inc. | Ceragem International, Inc. | | |
| 510(k) Number | K220572 | K202937 | | |
| Regulation Number | 21 CFR 890.5880,<br>21 CFR 890.5650 | 21 CFR 890.5880 | N/A | |
| Product Code | JFB, IRP | JFB | | |
| Indications for Use<br>(IFU) | The intended use of the Ceragem Automatic<br>Thermal Massager,<br>Model CGM MB-1701 & CGM MB-1702 is to<br>provide muscle relaxation therapy by delivering<br>heat and soothing massage. Additionally, the<br>product provides topical radiant infrared heat<br>for:<br>-Temporary relief of minor muscle and joint<br>pain stiffness<br>-Temporary relief of minor joint pain associated<br>with arthritis<br>-Temporary increase in local circulation where<br>applied<br>- Relaxation of muscles<br>The Air Cell Massager (only CGM MB-1701) is<br>indicated for the temporary relief of minor<br>muscle aches and pains and for temporary<br>increase in blood circulation to the treated areas.<br>The Air Cell Massager stimulates kneading and<br>stroking of tissues by using an inflatable<br>garment. | The intended use of the Ceragem Automatic<br>Thermal Massager,<br>Model CGM MB-1701 & CGM MB-1702<br>is to provide muscle relaxation therapy by<br>delivering heat and soothing massage.<br>Additionally, the product provides topical<br>radiant infrared heat for:<br>- Temporary relief of minor muscle and<br>joint pain stiffness<br>- Temporary relief of minor joint pain<br>associated with arthritis<br>- Temporary increase in local circulation<br>where applied<br>- 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<br>(Note 1) |
| | Remote Control | Yes | Yes | |
| | Operation Method | Auto / Manual | Auto / Manual | |
| | Infrared Emission<br>Spectrum | Ceramic: 5~20<br>Epoxy Carbon Panel: 5~20 | Ceramic: 5~20<br>Epoxy Carbon Panel: 5~20 | |
| Heating<br>Device | Voltage | 24V | 24V | |
| | Power | 28.8W | 28.8W | |
| | Temperature Range | Internal: 30°C - 65°C (86°F - 149°F)<br>External, Main, Auxiliary: 30°C - 60°C (86°F -<br>140°F) | Internal: 30°C - 65°C (86°F - 149°F)<br>External, Main, Auxiliary: 30°C - 60°C (86°F -<br>140°F) | |
| | Distance of the Internal<br>Projector | 710mm | 710mm | |
| | Intensity Level | 1~9<br>(12.9~69.2mm) | 1~9<br>(12.9~69.2mm) | |
| | Extra Overheating<br>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<br>Polyurethane | Nylon<br>Polyurethane | |
| | | | | |
| Projectors | Internal Projector | Ceramic Rollers | Ceramic Rollers | |
| | External Projector | Ceramic Heads Projector | Ceramic Heads Projector | |
| Mat Dimensions | | • When spread out:<br>: 728.2mm x 2012.4mm x 431.5mm (±5mm)<br>• When folded:<br>: 728.2mm x 2044mm x 431.5mm (±5mm) | • When spread out:<br>: 728.2mm x 2012.4mm x 431.5mm (±5mm)<br>• When folded:<br>: 728.2mm x 2044mm x 431.5mm (±5mm) | |
| | Weight | Weight: 62kg for CGM MB-1701,<br>57kg for CGM MB-1702 | Weight: 62kg for CGM MB-1701,<br>57kg for CGM MB-1702 | |
| | Mode | Mode A | Mode A | |
| | | Mode 1 | Mode 1 | |
| | | Mode 2 | Mode 2 | |
| | | Mode 3 | Mode 3 | |
| | | Mode 4…