(111 days)
The KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Not Found
The provided document is a 510(k) clearance letter for the KenkoWave Infrared Treatment System. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The letter focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market the product.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications from this document. This letter is a regulatory approval, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2004
Kaylight Corporation C/o Mr. Frank O'Brien Senior Staff Engineer Underwriters Laboratories, Inc 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K033555
Trade/Device Name: KenkoWave Infrared Treatment System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 13, 2004 Received: February 18, 2004
Dear Mr. O'Brien:
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 adultcration.
If your device is classified (see above) into cither 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 Codc 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. Frank O'Brien
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter 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 in you a the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gotterers, 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033555
Device Name: KenkoWave Infrared Treatment System
Indications For Use:
The KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provoost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number
N/A