(133 days)
Thermal Massage Bed (2D-GX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the lamps provide topical heating. -temporary relief of minor muscle and joint pain, and stiffness -temporary relief of minor joint pain associated with arthritis -temporary increase in local circulation where applied -Relaxation of muscles
This device is intended to provide patient with muscle relaxation therapy by delivering heat and soothing massage. This device has auto mode, and four custom modes to massage the back and apply heat to calves and thighs. For the upper mattress, there are germanium ceramic roller controlled left and right by motor. Germanium ceramic roller also can be controlled up and down. The users can choose the auto mode or custom mode by using the remote control and the remote control has the FND screen which shows the temperature and LED which indicates operation condition.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Thermal Massage Bed (2D-GX)
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific quantitative acceptance criteria for performance in the same way one might for diagnostic accuracy or detection rates. Instead, the "acceptance criteria" appear to be broadly demonstrating safety and the ability to achieve a therapeutic temperature range.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device meets applicable electrical and medical device safety standards. | The device has been tested to and meets the requirements of IEC60601-1, IEC 60601-2-38, and IEC60601-1-2. Risk analysis and mitigation strategies were also discussed (e.g., temperature control by sensor and bimetal, system shutdown if sensors are disconnected, motor initialization on shutdown). |
| Therapeutic Effect (Heat): Ability to elevate skin surface temperature to a therapeutic range (40-45℃). | "The device is able to elevate skin surface temperature from normal baseline temperature to the therapeutic range (40~~45℃) when the device activated by 65℃ setting." (Note: this is only achieved at the maximum setting; 30℃ setting is for comfort warming only). |
| Substantial Equivalence: To the predicate device (2D-LX). | The document states: "The non-clinical testing and clinical study results demonstrate that the 2D-GX, thermal massage bed is safe, accurate. It also demonstrates that the 2D-GX, thermal massage bed is substantially equivalent to the predicate device, 2D-LX, currently sold on the U.S. market." This is supported by direct comparison of features and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Test (Clinical Test): 5 people (for the temperature elevation study).
- Data Provenance: Not explicitly stated, but given the company's address in Korea, it is highly likely the study was conducted in Korea. The study is described as a "clinical test," suggesting it was conducted prospectively for the purpose of this submission.
- Sample Size for Non-Clinical Tests: Not specified, but these refer to compliance with standards (IEC 60601-1, -1-2, -2-38). These are typically laboratory tests of the device itself, not with human subjects, and involve standardized test configurations rather than "test sets" in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the clinical study on skin surface temperature elevation, the concept of "ground truth" established by experts is not directly applicable. The "ground truth" here is the objective measurement of skin surface temperature. No external experts are mentioned as establishing the truth for these temperature measurements.
4. Adjudication Method for the Test Set
Not applicable, as the clinical study involves direct physiological measurement (skin temperature) rather than subjective assessments requiring adjudication or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a thermal massage bed, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance are outside the scope of this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical therapy device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the clinical performance test, the ground truth was objective physiological measurement: the skin surface temperature, measured before and after device activation. For the safety tests, the ground truth was compliance with recognized international safety standards.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
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510(k) Summary
[as required by 807.92(c)]
A. 510K Number
K 10228 1
B. 510(K) Preparer
Company name: Business Association Co., Ltd.
Address: Migun Techno world II C-dong 524, #533-1 Yongsan-dong Yuseong-gu, Daejeon, KOREA
C. 510(K) Owner
INAREX CORPORATION Name of contact person: Heui-Jong Baek Address: 737-5 Ancheong-Dong Gwangsan-Gu, Gwangju, Korea Telephone Number: +82-62-952-1051 Fax Number: +82-62-952-1054
D. Regulatory Information
- Classification Name: Table, physical therapy, multi function
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- Common/Usual Name: Thermal massage bed
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- Proprietary Name: Thermal massage bed (2D-GX)
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- Classification /Product Code: Class II / JFB (21 CFR 890.5880)
E. Identification of the legally marketed device
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- Classification Name: Table, Physical therapy, Multi function
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- Common/Usual Name: Thermal massage bed
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- Proprietary Name: Thermal massage bed (2D-LX)
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- Classification /Product Code: Class II / JFB (21 CFR 890.5880)
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- 510(K) Number: K080554
F. Intended Use
Thermal Massage Bed (2D-GX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the lamps provide topical heating. -temporary relief of minor muscle and joint pain, and stiffness -temporary relief of minor joint pain associated with arthritis
-temporary increase in local circulation where applied
-Relaxation of muscles
G. Device Description
This device is intended to provide patient with muscle relaxation therapy by delivering heat and soothing massage. This device has auto mode, and four custom modes to massage the back and apply heat to calves and thighs. For the upper mattress, there are germanium
DEC 2 2 2010
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ceramic roller controlled left and right by motor. Germanium ceramic roller also can be controlled up and down. The users can choose the auto mode or custom mode by using the remote control and the remote control has the FND screen which shows the temperature and LED which indicates operation condition.
| Feature | Specification | |
|---|---|---|
| Upper and Lowerbody mattress | Temperature setting | 30°C/35°C/40°C/45°C/50°C/55°C/60°C/65°C/OFF. |
| Vertical control | Operated by using up/down photo sensor | |
| Horizontal Control | Operated by using Hall effect sensor | |
| AUX8 | Temperature setting | 30°C/35°C/40°C/45°C/50°C/55°C/60°C/65°C/OFF. |
| Time setting | 15/30//45/60/15 (Minutes) | |
| Mode | Auto modeCustom mode1,2,3,4 | |
| Weight | 75Kg | |
| Dimensions | 2,000mm(L)x 700mm(w) x 550mm(H) |
H. Technological Characteristics:
I. Substantial Equivalence Comparison
This device, INAREX CORPORATION, thermal massage bed (2D-GX) and predicate device are substantially equivalent and have the same intended use. Technological and performance difference do not raise any new questions of safety or effectiveness. Comparison analysis, including comparison tables, of the subject device versus the predicate device is provided as below:
| Model Name | 2D-GX | 2D-LX | |
|---|---|---|---|
| 510(K) Number | None yet | K080554 | |
| Classification | Table, physical therapy, multifunction (Class II),21 CFR 890.5880 | Same | |
| Intended Use | Thermal Massage Bed (2D-GX) isa device intended to providepatients with muscle relaxationtherapy by delivering heat andsoothing massage. Additionally, thelamps provide topical heating. | Same | |
| Indications | Thermal Massage Bed (2D-GX) isa device intended to providepatients with muscle relaxationtherapy by delivering heat andsoothing massage.Additionally, the lamps providetopical heating | Same | |
| -temporary relief of minor muscleand joint pain, and stiffness | |||
| -temporary relief of minor jointpain associated with arthritis | |||
| -temporary increase in localcirculation where applied | |||
| -Relaxation of muscles | |||
| Standards | IEC60601-1IEC60601-1-2IEC60601-2-38. | Same | |
| Rated supply volt | 120V~/230V~ | Same | |
| Supply Frequency | 50/60Hz | Same | |
| Power Consumption | Max.230VA | 200W | |
| Dimensions | 2,000mm(L)x700mm(W)x550mm(H) | 2,000mm(L)x700mm(W)x700mm(H) | |
| Weight | 75Kg | 88Kg | |
| Safe Working Load | Max.170Kg | Same | |
| Use temperature | 30°C~65 °C | Same | |
| Upperbodymattress | GeneralDescription | Programmed to apply thermalmassage to upper body byoperating germanium roller. | Programmed to applythermal massage to upperbody by operating jaderoller. |
| Up/Down | Rack Gear type | Cam Follower type | |
| Up/Downlimmit | -Photo Sensor applied-LED for checking the workingcondition | Mechanical limmit switch | |
| LAMPLeft &righttransmissionlimmit | Same-Hall effect sensor applied-LED for checking the workingcondition | 12v 10wMechanical limmit switch | |
| Massageroller | Germanium ceramic | Jade | |
| Lowerbodymattress | GeneralDescription | Apply heat to the lower body on thelower body mattress.-For the component of lowermattress, there are heating filmprotection , heating panel, heatingfilm protection, non woven fabric,Germanium ceramic and netmaterial ( written in order) | Give thermal massagetherapy by operating jaderoller. |
| Heatingpanel | -Two heating film protectionprotect heating panel back and forth | Not Applicable | |
| Control panel | It contains terminal for the powersupply, auxiliary hand-held unit,remote control, and connectingcables. | Same | |
| Auxilia | GeneralDescription | ||
| ryhandheld unit | Can apply heat directly to the bodyby one set of germanium hand-held unit | Can apply heat directly tothe body by two sets of jadehand-held unit. | |
| 2 Aux | Eliminated | Applied | |
| 8 Aux | The caps are made of Germaniumceramic | AppliedThe caps are made of Jade | |
| Outer Cover | Removable and hand washable foreasy cleaning | Same | |
| Remotecontroller | GeneralDescription | A user friendly remote control thatcontrols all functions automaticallyor manually. | Same |
| Buttons | Rubber pad type (similar to TVremote control) | Sticker pad type | |
| Temp./Time | Display area is wider than 2D-LX | ||
| Repeatingterm | Repeating term is divided into fourterms. | None | |
| Heightcontrol | (L1, L2, L3) 3 Steps, height ismeasured from the head side (upperside). | (L1, L2, L3)3 Steps, heightis measured from the lowerside. | |
| Software | MCU Atmega32 | MCU Atmega128 | |
| -Due to change of MCU Atmega32 to MCU Atmega128, programsize2D-LX (75KB) has been changed into 2D-GX (95KB). In | |||
| addition, due to the change of I/O from the chip itself, firmware is | |||
| changed and sources of each part are distinguishable and those | |||
| make the device modifiable. | |||
| Feature | Thermal method is modified by using Germanium ceramic andheat on the lower part. | ||
| Riskanalysis | Potentialnewhazardintroduced by themodification | -Heat transfer rate of germanium ceramic is higher than that of jadeand this makes temperature goes higher than 2D-LX. | |
| -There is no control system for overload of motor | |||
| Causes ofthehazards | -Temperature of upper germanium roller is higher than that of jaderoller. | ||
| -If there is no bimetal and control system, temperature goes up to120°C | |||
| -Surface temperature of 8 Auxiliary handheld unit is higher than2D-LX. | |||
| -If the upper body left &right limmit sensor(hall sensor) is bad, it ishard to control(Activation is checkable by naked eyes) | |||
| -There is no other control system for motor load. (Even if there islarge load while motor is activating, output keeps coming out.) | |||
| Potentialeffects onthe user | There is possibility of burning by germanium ceramic roller orcam. | ||
| Theseverity | 4 |
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| level | |
|---|---|
| Theactionstaken tomitigatethe risks | -Temperature is controlled by temperature sensor |
| -If the temperature control system is bad, power turns OFF bybimetal. | |
| -Temperature control of lower heat is designed to make lowertemperature than actual temperature. (Checking temperaturevariation) | |
| -If the Hall effect sensor and Photo sensor are not connected, erroroccurs and system stops. | |
| -System turns OFF when the remote control and 2D-GX isseparated. | |
| -Motor should go to head side, and up/down position should bedown side when the device is off. Device does not turn off if it isnot initialized. |
J. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
The Model 2D-GX thermal massage bed has been tested to and meets the requirements of the following standards.
IEC60601-1 :88+A1:91+A2:95 Medical electrical equipment-Part1:General requirements for safety
IEC 60601-2-38:1996+A1:1999Medical electrical equipment Part2: Particular requirements for the safety of electrically operated hospital beds
IEC60601-1-2:2007 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.
K. Discussion of Clinical Tests Performed:
The performance test was performed in order to show the safety of the device and to show the device can make the therapeutic range (40-45℃) from the users' skin surface temperature. By testing 30℃ and 65℃ (minimum and maximum of the device temperature setting) for 5 people, the device is able to elevate skin surface temperature from normal baseline temperature to the therapeutic range (40~~45℃) when the device activated by 65℃ setting. And for 30℃ setting, device has not been shown to provide a therapeutic effect and is indicated for comfort warming only.
L. Conclusion:
The non-clinical testing and clinical study results demonstrate that the 2D-GX, thermal massage bed is safe, accurate. It also demonstrates that the 2D-GX, thermal massage bed is substantially equivalent to the predicate device, 2D-LX, currently sold on the U.S. market.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Inarex Corporation % Ms. Eileen Yang Business Association Co., Ltd. Migun Techno World II C-dong 524 #533-1 Yongsan-dong Yuseong-gu Daejeon, KOREA
DEC 2 2 2010
Re: K102281
Trade/Device Name: Thermal Massage Bed, Model No. 2D-GX Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Received: November 30, 2010
Dear Ms. Yang:
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.
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Eileen Yang
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
AC is. nh
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
DEC 2 2 2010
K102281 510(k) Number (if known):
Device Name: Thermal Massage Bed Model No. 2D-GX
Indications for Use: Thermal Massage Bed (2D-GX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for:
-Temporary relief of minor muscle and joint pain, and stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied
-Relaxation of muscles
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102281
§ 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).