(181 days)
Thermal Massage Bed (2D-LX) 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
Thermal Massage Bed (2D-LX) 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
The given document is a 510(k) summary for the INAREX Thermal Massage Bed (2D-LX). It mainly focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and specific study performance data for the device itself against those criteria.
Therefore, many of the requested details cannot be extracted from this document, as it describes a clearance based on substantial equivalence, not a direct clinical validation study with specific performance metrics.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document focuses on demonstrating equivalence to predicate devices (Ceragem-C and Ceragem-RH1) regarding intended use, design, and function, rather than setting specific acceptance criteria for performance metrics (e.g., specific temperatures, massage force, or clinical outcomes) and then reporting the INAREX device's performance against those. The comparison table provided lists technical specifications (Voltage, Power, Frequency, Ambient temperature, Classification) and shows them to be comparable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states "Testing was performed according to 'Harmonized Standard'. Software testing and validation were done according to EN 60601-1-4. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement about engineering and software validation, not a clinical test set with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. No clinical ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No clinical test set or adjudication method is described.
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
This information is not applicable/not provided. The device is a "Thermal Massage Bed," not an AI-powered diagnostic or interpretive system that would involve human "readers" or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a physical therapy bed; it does not involve algorithms in a standalone diagnostic or interpretive capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. No clinical ground truth is mentioned. The testing described pertains to safety and performance according to harmonized standards (e.g., electrical safety, software validation), not clinical outcomes.
8. The sample size for the training set
This information is not applicable/not provided. This device does not appear to involve machine learning or a "training set" in the context of AI development.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, no training set or ground truth for it is mentioned.
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Image /page/0/Picture/1 description: The image shows the logo for INAREX Corporation. The logo consists of a circular graphic to the left of the company name. The graphic contains three white lines that appear to be moving from the upper right to the lower left. The company name is written in bold, black letters.
735-10, Ancheong-dong, Gwangsan-gu, Gwangju, Korea 82-62-952-1052 FAX:+82-62-954-1055 ttp://www.inarex.co.kr
AUG 2 7 2008
510[K] SUMMA
[as required by 807.92(c)]
-
- Identification of the Device:
-Proprietary-Trade Name: "INAREX" INAREX CORPORATION -Classification Name: Table, Physical Therapy, Multifunction, Product Code: JFB
- Identification of the Device:
-Common/Usual Name: Thermal Massage Bed
-
- Indications for Use (intended use):
Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating.
- Indications for Use (intended use):
-
- Description of the device:
Thermal Massage Bed (2D-LX) 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;
- Description of the device:
-
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
-
- Safety and Effectiveness, comparison to predicate device:
| Intended Use | INAREX | CERAGEM-C (K040031) | CERAGEM-RH1 (K062476) |
|---|---|---|---|
| Thermal Massage Bed(2D-LX) is a deviceintended to providepatients with musclerelaxation therapy bydelivering heat andsoothing massage.Additionally, the infraredlamps provide topicalheating | The intended use of theCERAGEM - C ThermalMassager is to provide theuser with muscle relaxationtherapy by delivering heatand soothing massage.Additionally, the productprovides topical radiantinfrared heating. | The intended use of theCERAGEM - RH1 ThermalMassager is to provide theuser with muscle relaxationtherapy by delivering heat andsoothing massage.Additionally, the productprovides topical radiantinfrared heating |
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Image /page/1/Picture/0 description: The image shows the logo for INAREX Corporation. The logo consists of a black circle with three white lines going through it, followed by the word "INAREX" in bold black letters. Below the word "INAREX" is the word "INAREX CORPORATION" in smaller, non-bolded black letters.
735-10, Ancheong-dong, Gwangsan-gu, Gwangju, Korea TEL:+82-62-952-1052 FAX:+82-62-954-1055 http://www.inarex.co.kr
| Voltage | AC 120V | 110V | AC 120V |
|---|---|---|---|
| Power | MAX 230W | MAX 200W | MAX 200W |
| Frequency | 50Hz ~ 60Hz | 60Hz | 60Hz |
| Ambient temperature | 30°C ~ 65°C | 30°C ~ 65°C (86 ~ 140°F) | 30°C ~ 65°C (86 ~ 140°F) |
| Classification | table, physical therapy, multi function (Class II), 21 CFR 890.5880 | table, physical therapy, multi function (Class II), 21 CFR 890.5880 | table, physical therapy, multi function (Class II), 21 CFR 890.5880 |
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- Testing information and Conclusion
In all material respects, the "INAREX" is substantially equivalent to Ceragem-C (K040031, CERAGEM CO., LTD.) Testing was performed according to 'Harmonized Standard'. Software testing and validation were done according to EN 60601-1-4. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the bird. The bird symbol is composed of multiple curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2008
Inarex Corporation % PATS Corporation Mr. Brandon Choi Flemington Court # 155 La Mirada, California 90638
Re: K080554 Trade Name: Inarex Thermal Massage Bed, Model 2D-LX Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table. Regulatory Class: Class II Product Code: JFB Dated: August 22, 2008 Received: August 22, 2008
Dear Mr. Choi:
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 for associous 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 such additional controls. Existing major regulations affecting your device can he 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); 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.
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Page 2 – Mr. Brandon Choi
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you're organ mailing of substantial equivalence of your device to a legally prematice notification. Theesults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou don't specific and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 210 0126. This) (21CFR Part 807.97). For questions regarding postmarket surveillance, premance notification (2) (2011) s Office of Surveillance and Biometric's (OSB's) Division of Postmarket preaso connect 240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Nedical De 100 Reporting (2011) other general information on your responsibilities under the at (210) 210 Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for INAREX Corporation. The logo consists of a circular graphic to the left of the word "INAREX" in bold, sans-serif font. Below "INAREX" is the text "INAREX CORPORATION" in a smaller, sans-serif font. The circular graphic appears to be a stylized representation of a sphere with lines running through it.
735-10, Ancheong-dong, Gwangsan-gu, Gwangju, Korea TEL:+82-62-952-1052 FAX:+82-62-954-1055 http://www.inarex.co.kr
Indications for Use
510(k) Number (if known):
Device Name: Thermal Massage Bed
Indications for use:
"Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and smoothing massage. Additionally, the thermal 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 × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Milherson
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devic
gical Devices
mber
510(k) Number
§ 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).