(314 days)
The Innovative Med Multi Wave Light Therapy System is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Innovative Med Multi Wave Light Therapy System
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Innovative Med Multi Wave Light Therapy System." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.
It's a regulatory approval letter for a light therapy system, classifying it as an "Infrared lamp" (product code ILY), and indicating that it is substantially equivalent to predicate devices. The letter outlines the intended use for topical heating, temporary relief of minor muscle and joint pain, relieving stiffness, promoting muscle relaxation, and temporarily increasing local blood circulation.
Therefore, I cannot fulfill your request based on the provided text. The requested information pertains to clinical performance evaluation of a device, usually found in a clinical study report or a different section of a 510(k) submission that contains performance data, which is not present in this regulatory correspondence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innovative Med. Inc. % Mr. Jeffrey Kolster VP Regulatory Affairs 4 Autry, Suite B Irvine, California 92618
AUG 2 3 2010
Re: K093204
Trade/Device Name: Innovative Med Multi Wave Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 10, 2010 Received: August 10, 2010
Dear Mr. Kolster:
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. 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.
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
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Page 2 - Mr. Jeffrey Kolster
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 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/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,
Sincerely yours,
Minh A. Millican
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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Section 8.0
Indications for Use
510(k) Number 093204
Device Name: Innovative Med Multi Wave Light Therapy System
Indication for Use:
The Innovative Med Multi Wave Light Therapy System is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Prescription Use XXX (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K. Ogden for max
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093204
N/A