(169 days)
Not Found
No
The summary describes a physical therapy device that uses mechanical massage and heat. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "physical therapy table" with an "intended use...to provide muscle relaxation therapy by delivering heat and soothing massage" and for "temporary relief of minor muscle and joint pain stiffness" and "temporary relief of minor joint pain associated with arthritis". These are all therapeutic applications.
No
The device is described as an automatic thermal massager intended for providing muscle relaxation, temporary relief of pain and stiffness, and increased local circulation. Its function is therapeutic, not diagnostic; it does not identify or detect medical conditions.
No
The device description clearly outlines multiple hardware components including a main table mat, supporting mat, projectors, a remote control, motors, ceramic balls, and heating pads. While software is mentioned for validation, the device is fundamentally a physical therapy table with hardware components providing the therapeutic effects.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ceragem Automatic Thermal Massager provides physical therapy through heat and massage applied externally to the body. It does not analyze any biological samples.
- Intended Use: The intended use clearly states "muscle relaxation therapy," "temporary relief of minor muscle and joint pain," "temporary increase in local circulation," and "relaxation of muscles." These are all physical effects, not diagnostic analyses of biological samples.
- Device Description: The description details components like a main table mat, projectors, motors, and heating pads, all of which are involved in delivering physical therapy. There is no mention of components for sample collection or analysis.
Therefore, based on the provided information, the Ceragem Automatic Thermal Massager is a physical therapy device, not an In Vitro Diagnostic device.
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
Product codes (comma separated list FDA assigned to the subject device)
JFB
Device Description
The Ceragem Automatic Thermal Massager which offers two models, CGM MB-1701 & CGM MB-1702 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 up and down movement of the internal motor, and heat from the internal and external projectors.
The main components of the subject device are a main table mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main table 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 up/down and vertically along the spinal line. The main table mat has a heating pad for thermal effect.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and 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.
The only difference between the model CGM MB-1701 and the CGM MB-1702 is that the CGM MB-1701 has an air massage module for calf on the supporting mat. The supporting mat of the both models has a heating pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body (Spine, neck, armpit, abdominal area, calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Use (Over-The-Counter 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): 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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
March 18, 2021
Ceragem Co, Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K202937
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 Dated: December 14, 2020 Received: December 22, 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202937
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
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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510(k) Summary
(K202937)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Feb 23, 2021
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-1701 & CGM MB-1702
- 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 which offers two models, CGM MB-1701 & CGM MB-1702 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
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pressure from up and down movement of the internal motor, and heat from the internal and external projectors.
The main components of the subject device are a main table mat, a supporting mat, a 3-Sphere projector, an abdominal vibration projector, and a remote control. The main table 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 up/down and vertically along the spinal line. The main table mat has a heating pad for thermal effect.
The 3-sphere projector is an optional accessory which the user can put anywhere needed additionally such as neck and armpit, and 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.
The only difference between the model CGM MB-1701 and the CGM MB-1702 is that the CGM MB-1701 has an air massage module for calf on the supporting mat. The supporting mat of the both models has a heating pad.
8. 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
9. Substantial Equivalence Discussion:
9.1. Comparison Chart
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Device Name | Ceragem Automatic Thermal Massager, | ||
| Model CGM MB-1701&CGM MB-1702 | CGM MB-1101 | ||
| Automatic Thermal Massager | |||
| Manufacturer | Ceragem International, Inc. | Ceragem International, Inc. | |
| 510(k) Number | K202937 | 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 Table | ||
| Supporting Mat | |||
| Remote Control | |||
| 3-Sphere projector | Main Table | ||
| Supporting Mat | |||
| Remote Control | |||
| 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 | ||
| Calf Massager | |||
| 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 | Voltage | 24V | 24V |
| Device | Power | 28.8W | 15W |
| 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 - 49°F) | ||
| • External, Main, Auxiliary: 30°C - 60°C(86°F - 140°F) | |||
| Distance of the Internal Projector | 710mm | 710mm | |
| Intensity Level | 1~9 | ||
| (12.9~69.2mm) | 1~6 | ||
| (21~75mm) | |||
| 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 | Nylon | ||
| Polyurethane | Polyurethane | ||
| Projectors | Internal | ||
| Projector | Ceramic Rollers | Jade Rollers | |
| External | |||
| Projector | Ceramic Heads Projector | Jade Heads Projector | |
| Mat Dimensions | • When spread out | ||
| 728.2mmx2012.4mmx431.5mm(±5mm) | |||
| • When folded | |||
| : 728.2mmx2044mmx431.5mm(±5mm) | • When spread out | ||
| 700mmx2016mmx450mm(±5mm) | |||
| • When folded | |||
| 700mmx1258mmx450mm(±5mm) | |||
| Weight | Weight: 62kg for CGM MB-1701, | ||
| 57kg for CGM MB-1702 | 53 kg | ||
| Mode A | Mode 1 | ||
| Mode 1 | Mode 2 | ||
| Mode 2 | Mode 3 | ||
| Mode 3 | Mode 4 | ||
| Mode 4 | Mode 5 | ||
| Mode | 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 |
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| Mode 12 | |
|---|---|
| Mode 13 | |
| Mode 14 | |
| Mode 15 | |
| Intensive Mode | |
| Semi-Automatic Mode | |
| Semi-Automatic Master Mode | |
| Manual Mode | |
| Manual Master Mode | |
| Abdominal Vibration Projector Mode | |
| Calf Mode |
9.2. Substantial Equivalence Discussion
The subject device is identical 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. Other differences are that the subject device has upgraded the 9-Sphere projector to have vibration feature for massage effect, and the subject model, CGM MB-1701, has an air massage module for calf on the supporting mat. These vibration and air massage functions are just additional features and still the main function is heating. The skin temperature test result supported that the Abdominal Vibration Projector and the supporting mat perform 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, andIEC 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
7
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.
11. Conclusions:
Based on the information provided in this premarket notification. CERAGEM Co, Ltd. concludes that the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 are substantially equivalent to the predicate device as described herein in.