INAREX, MODEL 2D-LX

{0}------------------------------------------------ K080554 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)] - 1. Identification of the Device: -Proprietary-Trade Name: "INAREX" INAREX CORPORATION -Classification Name: Table, Physical Therapy, Multifunction, Product Code: JFB -Common/Usual Name: Thermal Massage Bed - 2. Equivalent legally marketed device: This product is similar in design and identical in function to the Ceragem-C (K040031, CERAGEM CO., LTD.), Ceragem-RH1 (K062476, CERAGEM CO., LTD.) - 3. 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. - 4. 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; - 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 - 5. Safety and Effectiveness, comparison to predicate device: | Intended Use | INAREX | CERAGEM-C (K040031) | CERAGEM-RH1 (K062476) | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Thermal Massage Bed<br>(2D-LX) is a device<br>intended to provide<br>patients with muscle<br>relaxation therapy by<br>delivering heat and<br>soothing massage.<br>Additionally, the infrared<br>lamps provide topical<br>heating | The intended use of the<br>CERAGEM - C Thermal<br>Massager is to provide the<br>user with muscle relaxation<br>therapy by delivering heat<br>and soothing massage.<br>Additionally, the product<br>provides topical radiant<br>infrared heating. | The intended use of the<br>CERAGEM - RH1 Thermal<br>Massager is to provide the<br>user with muscle relaxation<br>therapy by delivering heat and<br>soothing massage.<br>Additionally, the product<br>provides topical radiant<br>infrared heating | {1}------------------------------------------------ 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 | - 6. 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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) ����������������������������������������������������������������������������������������������������������������������������������������������������������������������������� ## 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 K080534 **510(k) Number**