CERAGEM AUTOMATIC THERMAL MASSAGER

K140592 · Ceragem International, Inc. · JFB · Dec 17, 2014 · Physical Medicine

Device Facts

• Record ID: K140592
• Device Name: CERAGEM AUTOMATIC THERMAL MASSAGER
• Applicant: Ceragem International, Inc.
• Product Code: JFB · Physical Medicine
• Decision Date: Dec 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager 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

Device Story

Electrically powered, motorized physical therapy table; provides muscle relaxation and topical radiant infrared heat. Device consists of main mat with internal jade roller projector, lower mat, and optional external 3-sphere/9-sphere jade projectors. User lies on mat; motorized carriage moves jade rollers vertically/horizontally along torso to apply massage pressure. Internal lamps heat jade rollers; additional epoxy carbon panels and infrared heating elements provide supplemental heat. Operated via remote control; intended for home use. Heat and massage therapy aim to relieve minor muscle/joint pain, stiffness, and arthritis-associated pain, and increase local circulation. Safety features include limit switches for carriage movement and thermistors for temperature regulation.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through compliance with UL 60601-1, IEC 60601-1, IEC 60601-1-2, ISO 10993-10, and ISO 14971 standards.

Technological Characteristics

Motorized physical therapy table; steel/ABS frame; polyester/cotton/rayon/polyurethane massager cover; Oxford cover sheet. Sensing: Thermistor-based temperature control, limit switches for carriage. Energy: 100-127Vac, 360VA. Heating: Jade rollers (12V/24Vdc lamps), epoxy carbon panels, infrared heating elements. Emission: 5-20 micron infrared spectrum. Standards: UL 60601-1, CAN/CSA-C22.2 No. 601.1, IEC 60601-1, EN 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-10, ISO 14971.

Indications for Use

Indicated for adults seeking muscle relaxation therapy, temporary relief of minor muscle/joint pain and stiffness, relief of minor joint pain associated with arthritis, and temporary increase in local circulation.

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-C Thermal Massager (K040031)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2014

Ceragem International, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K140592

Trade/Device Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1101 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: November 17, 2014 Received: November 17, 2014

Dear E.J. Smith,

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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Page 2 - E.J. Smith

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel -S

for

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K140592

#### Device Name

Ceragem Automatic Thermal Massager, Model CGM-MB-1101

#### Indications for Use (Describe)

The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager 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

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 807.92(c)

510(k) Summary

| Sponsor: | Ceragem International, Inc. 807.92(a)(1) |
|------------------------------------|---------------------------------------------------------|
| Address: | 3699 Wilshire Blvd., 930<br>Los Angeles, CA 90010 |
| Contact Person: | Raymond Chung |
| Phone: | 213-480-7070 |
| Fax: | 213-341-2338 |
| Summary Prepared: | November 11, 2014 |
| Device Name: | 807.92(a)(2 |
| Trade Name: | Ceragem Automatic Thermal Massager<br>Model CGM-MB-1101 |
| Common/Usual Name: | Massage Table |
| Classification Name: | Table, Physical Therapy, Multi-Function |
| Establishment Registration Number: | 2087361 |
| Product Code: | JFB |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 890.5880 |

| Manufacturer | Brand Name | 510(k) Number |
|-----------------------------|----------------------------|---------------|
| Ceragem International, Inc. | CERAGEM-C Thermal Massager | K040031 |

## Device Description

This device is comprised of the main body and optional components. The main body components are the main mat which includes the internal projector and the up/down movement motor, and the lower mat. The optional components are the external projectors (3-sphere). This device is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle and joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.

## Indications for Use

The intended use of the Ceragem® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager 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

## 807.92(a)(4)

807.92(a)(5)

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#### 12.3 Predicate Product Comparison Chart

807.92(a)(6)

| | | Predicate Device | Subject Device |
|------------------------------|------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Brand Name and | Manufacturer | CERAGEM-C Thermal Massager<br>Ceragem International, Inc. | CGM MB-1101<br>Automatic Thermal Massager<br>Ceragem International, Inc. |
| 510(k) Number | | K040031 | |
| Rated Voltage | | AC 120V 60Hz | 100-127Vac 50/60Hz |
| Operation Power | | Maximum 280 Watts | 360 VA<br>240 Watts] |
| Home Use | | Yes | Yes |
| Style | | Flood Model (Massage Bed) | Flood Model (Massage Bed) |
| Remote Control | | Yes | Yes |
| Operation Method | | Auto / Manual | Auto / Manual |
| Emission Source | | Jade Projectors | Jade Projectors |
| Infrared Emission Spectrum | | Jade: 5 ~ 20<br>Epoxy Carbon Panel: 5 ~ 20 | Jade: 5 ~ 20<br>Epoxy Carbon Panel: 5 ~ 20 |
| Heating Lamp | Voltage | 12V | 24Vdc |
| | Power | 10W | 15W |
| Operating Temperature Range | | 30°C - 60°C (86°F - 140°F) | 1. Internal : 30°C – 65°C<br>(86°F - 149°F)<br>2. External, main, Auxiliary :<br>30°C - 60°C (86°F – 140°F) |
| Extra Overheating Protection | | Yes | Yes |
| Moving Device | | Geared DC Motor | Geared DC Motor |
| Limit Detector | | Limit Switch | Limit Switch |
| Temperature Sensor | | Temperature Coefficient<br>Variable Resistor | Thermistor |
| Control Method | | Microchip's Microcontroller | Microchip's Microcontroller |
| Tugging Method | | Wire-Chain | Wire-Chain |
| Material | Support Frame | Steel | Steel, ABS |
| | Massager | Vinyl | Polyester, Cotton, Rayon, Poly<br>urethane |
| | Cover | | |
| | Cover Sheet | Cotton | Oxford |
| | Rails | Ergonomically Molded<br>Polyethylene | Ergonomically Molded<br>Polyethylene |
| Internal Projector | | Ergonomic Tilting Jade Rollers | Ergonomic Tilting Jade Rollers |
| Jade Heads | Internal<br>Projector | 1 Jade Ball in the Middle 4 Jade<br>Rollers (Total of 5) | 1 Jade Ball in the Middle 4 Jade<br>Rollers (Total of 5) |
| | External<br>Projectors | Three (3) Jade Heads Projector<br>Nine (9) Jade Heads Projector | Three (3) Jade Heads Projector<br>Nine (9) Jade Heads Projector |
| | | | |
| Mat Dimensions | | 1920mm x 550mm x 130mm<br>76 in x 22 in x 5 in<br>(L x W x H) | 1. When spread out<br>: 700mm×2016mm×450mm(±5mm)<br>2. When folded<br>:700mm×1258mm×450mm(±5mm) |
| Weight | | Approximately 38 Kg (84 lb.) | Main body: 23kg(±2kg) |
| | | Sliding support: 14kg(±2kg)<br>Frame: 16kg(±2kg) | |
| Patient Population | Adult | Adult | |

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#### 12.4 Differences Table

| | | Predicate Device | Subject Device | Difference |
|-----------------------------|---------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Rated Voltage | | AC 120V 60Hz | 100-127Vac 50/60Hz | Changed SMPS<br>(switched-mode<br>power supply) |
| Operation Power | | Maximum 280 Watts | 360 VA<br>[240 Watts] | Changed SMPS<br>(switched-mode<br>power supply) |
| Heating Lamp | Voltage | 12V | 24Vdc | Changed the heating<br>element |
| | Power | 10W | 15W | |
| Operating Temperature Range | | 30°C – 60°C (86°F –<br>140°F) | 1. Internal : 30°C−65°C<br>(86°F - 149°F)<br>2. External, main,<br>Auxiliary :<br>30°C – 60°C (86°F – 140°F) | Changed internal<br>temperature range |
| Temperature Sensor | | Temperature Coefficient<br>Variable Resistor | Thermistor | No changes |
| Material | Support Frame | Steel | Steel, ABS | Added new<br>components |
| | Massager<br>Cover | Vinyl | Polyester, Cotton, Rayon,<br>Poly urethane | Changed components |
| | Cover Sheet | Cotton | Oxford | Changed components |
| | Rails | Ergonomically Molded<br>Polyethylene | Ergonomically Molded<br>Polyethylene | |
| Mat Dimensions | | 1920mm x 550mm x<br>130mm<br>76 in x 22 in x 5 in<br>(L x W x H) | 1. When spread out<br>: 700mm×2016mm×450mm<br>(±5mm)<br>2. When folded<br>: 700mm×1258mm×450mm | New design (Sliding<br>in/out structure) |
| | | (±5mm) | | |
| Static Weight | 300 | 298 pounds | Substantially<br>Equivalent | |
| Maximum Permissible Weight | 300 | 298 pounds | Substantially<br>Equivalent | |
| Weight | Approximately 38 Kg<br>(84 lb.) | Main body: 23kg(±2kg)<br>Sliding support:<br>14kg(±2kg)<br>Frame: 16kg(±2kg) | Changed design | |

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#### 12.4 Discussion of Technological Characteristics

## 807.92(b)(1)

Both CGM MB-1101 and the predicate device use massage rollers and heat to provide muscle relaxation therapy. The CGM MB-1101 emits topical radiant infrared heat in the range of 5-20 microns from the jade massage rollers, heated by lamps located inside the rollers. The predicate device also emits topical heat through lamps located in the jade massage rollers in the range of 5-20 microns. Both the CGM MB-1101 device and the predicate provide the massage component by attaching the jade rollers to a carriage mounted under a padded cushion that traverses the torso. The CGM MB-1101 device also transmits heat through the two Epoxy Carbon Panels and an infrared-rays heating element. While the predicate device does not include Epoxy Carbon Panels, the maximal heat of the CGM MB-1101 remains lower than that of the predicate. Additionally, both CGM MB-1101 and the predicate device have been tested to and meet the following standards:

- 1. UL 60601-1, 1st Edition, 2006-04-26 (include National Differences for USA)
- CAN/CSA-C22.2 No. 601.1-M90 (R2005) (includes National Differences for Canada) 2.
- 3. IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007)
- 4. EN 60601-1:2006 + CORR: 2010 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
- 5. IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General Requirements for Electromagnetic Compatibility
- IEC 62304 Medical device Software Software Life Cycle Processes 6.
- 7. ISO 10993-10 Biological Evaluation of medical Devices Part 10: Tests for Irritation and Skin Sensitization
- 8. ISO 14971 Medical Devices Application of Risk Management to Medical Devices

#### 12.5 Conclusions

# 807.92(b)(3)

Based on comparison of the CGM Mb-1101 to the predicate device, we conclude that the CGM MB-1101 has the same intended use, indications for use, and intended population, and similar

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functional and performance characteristics. The addition of the two Epoxy panels and one infrared-rays heating element does not raise new safety or effectiveness issues since the temperature never exceeds the maximal temperature of the predicate device. Other visual distinctions do not impact safety or effectiveness.