(215 days)
Not Found
No
The description focuses on mechanical and thermal functions, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for muscle relaxation therapy, temporary relief of pain and stiffness, and temporary increase in circulation, which are all therapeutic purposes.
No
The device is described as a massager that provides heat and soothing massage for muscle relaxation and pain relief. Its intended use and device description focus on therapeutic effects rather than diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including mats, projectors, motors, and a remote control, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "muscle relaxation therapy by delivering heat and soothing massage" and provides "topical radiant infrared heat" for pain relief, circulation increase, and muscle relaxation. These are all physical therapy and pain management applications, not diagnostic testing performed on samples taken from the body.
- Device Description: The description details a physical therapy table with massage and heating elements. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The device is clearly intended for external application to the body for therapeutic purposes, which falls under the category of physical medicine or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
Product codes
JFB
Device Description
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Use
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)
- The skin temperature study was performed to verify that the subject device maintained skin temperature between 40-45 degree C during the intended treatment.
- 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.
- The cytotoxicity test per ISO 10993-5 and skin irritation & sensitization tests per ISO 10993-10 were performed to evaluate the safety of the new materials which contact the patients.
- The level of concern for the subject device SW is moderate and the validation tests were performed to verify that the firmware works as intended.
The test results of all the tests supported that it is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 2, 2021
Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K202113
Trade/Device Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1901 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: December 14, 2020 Received: December 21, 2020
Dear Priscilla Chung:
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
1
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,
Jitendra Virani Acting 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
2
Indications for Use
510(k) Number (if known) K202113
Device Name
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Indications for Use (Describe)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
(K202113)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Feb 18, 2020
1. 510K Applicant / Submitter:
CERAGEM Co, Ltd. 10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, Chungcheongnam-do 31041 Republic of Korea
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Proprietary Name: Ceragem Automatic Thermal Massager, Model CGM-MB-1901 .
- Regulation Number: 21 CFR 890.5880
- Regulation Name: Multi-Function Physical Therapy Table .
- Regulatory Class: Class II
- Product Code: JFB ●
4. Predicate Device
Automatic Thermal Massager, Model CGM MB-1101 (K140592) by Ceragem International, Inc.
5. Description:
The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electrically powered, motorized, multi-functional physical therapy table intended to use for temporary
4
relief of muscle/joint pain and stiffness by applying massage pressure from the vertical and horizontal movements, and heat from the internal and external projectors.
The main components of the subject device are a main mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main mat has an internal projector which includes an up/down movement motor for pressure effect with ceramic balls as a medium for thermal massage effect. The internal projector is located in the center of the mat which is mainly for spine and moves up and down as well as vertically. The main mat also has a heating pad. The supporting mat which is mainly for the legs have heating pad only.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and it has 3 balls for thermal effect. The abdominal vibration projector is also an optional accessory mainly for abdominal area and offers vibration and thermal effect.
8. Indications for Use
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 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
9. Substantial Equivalence Discussion:
9.1. Comparison Chart
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | CGM MB-1901 | CGM MB-1101 |
| Automatic Thermal Massager | Automatic Thermal Massager | |
| Manufacturer | CERAGEM Co, Ltd. | CERAGEM Co, Ltd. |
| 510(k) Number | K202113 | K140592 |
| Rated Voltage | 100-127Vac 50/60Hz | 100-127Vac 50/60Hz |
| Home Use | Yes | Yes |
| Style | Flood Model (Massage Bed) | Flood Model (Massage Bed) |
| Components | Main Mat | Main Mat |
| Supporting Mat | Lower Mat | |
| Remote Control | Remote Control | |
| 3-Sphere projector | 3-Sphere projector | |
| Abdominal Vibration Projector | 9-Sphere projector | |
| Power cord | Power cord | |
| Outer fabric | Outer fabric | |
| Head cushion | Head cushion | |
| Projector Cover | Projector Cover |
5
| Remote Control | Yes | Yes | |||
|---|---|---|---|---|---|
| Operation Method | Auto / Manual | Auto / Manual | |||
| Infrared Emission Spectrum | Ceramic : 5~20µm | Jade : 5~20µm | |||
| Epoxy Carbon Panel : 5~20 µm | Epoxy Carbon Panel : 5~20 µm | ||||
| Heating | |||||
| Device | Voltage | 24V | 24V | ||
| Power | 18W | 15W | |||
| Temperature Range | 1. Internal: 30°C - 65°C | ||||
| (86°F - 149°F) |
- External, Main, Auxiliary:
30°C - 60°C(86°F - 140°F) | 1. 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 | 1975mm) | 1
(21675mm) | | |
(21
| | Extra Overheating Protection | Yes | Yes | | |
| | Moving Device | Geared DC Motor | Geared DC Motor | | |
| | Limit Detector | Limit Switch | Limit Switch | | |
| | Temperature Sensor | Thermistor | Thermistor | | |
| | 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
Cover | Nylon
Polyurethane | Polyethylene | | |
| Projectors | Internal
Projector | 1 Ceramic Ball in the Middle 4
Ceramic Rollers(Total of 5) | 1 Jade Ball in the Middle 4 Jade
Rollers(Total of 5) | | |
| | External
Projectors | Three (3) Ceramic Heads
Projector
Nine (9) Ceramic Heads Projector | Three (3) Jade Heads Projector
Nine (9) Jade Heads Projector | | |
| | Mat Dimensions | 1.When spread out:
700mmx2040mmx450mm(±5mm)
2.When folded:
700mmx1250mmx450mm(±5mm) | 1.When spread out:
700mmx2016mmx450mm(±5mm)
2.When folded:
700mmx1258mmx450mm(±5mm) | | |
| | Weight | Main/Supporting body :
52kg(±2kg) | Main body : 23kg(±2kg)
Sliding support : 14kg(±2kg)
Frame : 16kg(±2kg) | | |
| | Mode | Mode A | Mode 1 | | |
| | | Mode 1 | Mode 2 | | |
| | | Mode 2 | Mode 3 | | |
| | | Mode 3 | Mode 4 | | |
| | | Mode 4 | Mode 5 | | |
| | | Mode 5 | Mode 6 | | |
| | | Mode 6 | Mode 7 | | |
| | | Mode 7 | Mode 8 | | |
| | | Mode 8 | Mode 9 | | |
| | | Mode 9 | Semi-Automatic Mode | | |
| | | Mode 10 | Manual Mode | | |
| | | Mode 11 | | | |
6
| Semi-Automatic Mode | |
|---|---|
| Semi-Automatic Master Mode | |
| Manual Mode | |
| Manual Master Mode | |
| Abdominal Vibration Projector | |
| Mode |
9.2. Substantial Equivalence Discussion
The subject device is similar to the predicate device in the indications for use, principle of operation, and technological characteristics. The performance specifications are nearly the same, yet the subject device has more choosing options. For example, the intensity level specification is the same between the subject device and the predicate device, but the subject device divided the range into 9 options instead of 6 to better meet user's intensity preferences. The same thing applies to the massage mode that the overall massage specification is the same, but the subject device offers more variety of the massage patterns and options.
The major difference is the material of the internal heating element has changed. We have performed the skin temperature to validate the performance of the heating massage and the test results support that the subject device is substantially equivalent to the predicate device. Another difference is that the subject device has upgraded the 9-Sphere projector to have vibration feature for massage effect. So, we have changed the term for this component to Abdominal Vibration Projector. This vibration function is just an additional feature and still the main function of this projector is heating. The skin temperature test result supported that the Abdominal Vibration Projector performs as well as the predicate device. Similar to the predicate device, the subject device was able to heat skin to 40-45 degree C within 15-20 minutes. During the intended treatment the subject device maintained skin temperature between 40-45 degree C.
10. Performance Tests (Non-clinical)
- The skin temperature study was performed to verify that the subject device maintained ● skin temperature between 40-45 degree C during the intended treatment.
- 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.
- . The cytotoxicity test per ISO 10993-5 and skin irritation & sensitization tests per ISO 10993-10 were performed to evaluate the safety of the new materials which contact the patients.
- The level of concern for the subject device SW is moderate and the validation tests were ● performed to verify that the firmware works as intended.
The test results of all the tests supported that it is substantially equivalent to the predicate
7
device.
11. Conclusions:
Based on the information provided in this premarket notification, CERAGEM Co, Ltd. concludes that the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is substantially equivalent to the predicate device as described herein in.