← Product Code [ILY](/productcode/ILY) · K051961 # WWMED, MODEL 401 (K051961) _Wong Way Corporation · ILY · Feb 10, 2006 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K051961 ## Device Facts - **Applicant:** Wong Way Corporation - **Product Code:** [ILY](/productcode/ILY.md) - **Decision Date:** Feb 10, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use This device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle. ## Device Story The wwMed Model 401 is a Class II infrared lamp system used in clinical settings by trained healthcare professionals. The device emits infrared energy that penetrates the skin to underlying tissues to provide topical heating. It utilizes proprietary techniques and computational processes to deliver low-level light therapy. The device is intended to trigger normal cellular functions, providing a surgery-free and drug-free treatment option. Healthcare providers use the device to treat specific patient ailments based on established protocols. The output is intended to relieve pain and promote muscle relaxation, potentially benefiting patients by reducing symptoms associated with arthritis and muscle spasms. ## Clinical Evidence No clinical data provided. The document indicates the device has been tested for safety and efficacy through design, development, and production procedures conforming to Quality Systems, including factory calibration testing. ## Technological Characteristics Infrared lamp system; Class II; 21 CFR 890.5500; Product Code ILY. Emits energy in the infrared spectrum for topical heating. Includes proprietary computational processes. Operates as a prescription-only clinical device. ## Regulatory Identification An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating. ## Special Controls *Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. ## Predicate Devices - Palomar Medical Products ([K024179](/device/K024179.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Ko51961 FEB 1 0 2006 ## Section 4 Summary of Safety & Effectiveness 10 May 2005 The wwMed "" Model 401 is designed to be used only according to the Indications for Use, which are: "This device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and foint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle. This system is for clinical applications to provide low level light therapy. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY. This summary is submitted in behalf of: Wong Way Corporation 3 Alpine Lane. Darien, CT, USA 06820 Voice phone number-203 363 0676 Fax phone number- 203 363 0676 This summary is submitted by: Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut, 06907 voice phone number (203) 329 2700) fax phone number (203) 329 2345. This device can be described as a Class II Low Level Light treatment process employing the application of energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system. This device uses proprietary techniques and computational processes. I he scientific concept on which this device is based is the principle that by stimulating a local area with low level light to relieve pain. The intended use of this device is for a trained health care professional to diagnose that specific patients would benefit from this therapy and treat patients for specific ailments using specific protocols. This is a prescription only device. The labeling, instructions and user operations are designed for health care professionals. {1}------------------------------------------------ Koji 1961 ## Section 4 Summary of Safety & Effectiveness Wong Way Corporation has determined that this device is substantially equivalent to the Palomar Wong Tuy Corporation by Palomar Medical Products, which are currently in commerce as: K024179. A factory calibration test is conducted to verify the device is accurate and calibrated (and can maintain A factory canoration tost is ochadevewMed "" Model 401 has benefited from design, development, testing and production procedures that conform to Quality Systems. This device is safe and effective for the application for which it is intended and has been tested to 1 ms ac vice is sare and efficacy. Way Corporation continues to search all appropriate sources for Committ saccy and citiedly. Would in the interess and maintains an in-house reporting system to identify miormation relating to sarely and essessation and as such, applicable data is recorded for this product. ## CERTIFICATION: CENTIFICATION: I hereby extity this Summary of Safety and Effectiveness applies for the above indicated device. Dr. Edmund Wong Chairman Wong Way Corporation 3 Alpine Lane, Darien, CT, USA 06820 Voice 203 363 0676 203 363 0676 Fax {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 0 2006 Wong Way Corporation c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut 06907 Re: K051961 Trade/Device Name: wwMedTM Model 401 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: January 30, 2006 Received: February 2, 2006 Dear Mr. Keen: 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 such 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); 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. Keen This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Valeria Mielund for Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Section 2 Indications for Use 510(K) Number (If known): 0 051961 Device Name: wwMed "" Model 401 Indication For Use: The wwMed "" Model 401 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of muscles. Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR Over - The - Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF (Division Sign-Off Art and The Way for Alle Division of Generally Restorative DRH, Office of Device Evaluation (ODE) and Neurological Devices Sheet 1 of 1 KOS 1961 510(k) Number. --- **Source:** [https://fda-staging.innolitics.com/device/K051961](https://fda-staging.innolitics.com/device/K051961) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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