READY-HEAT BLANKET

{0}------------------------------------------------ Public Health Service SEP 17 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 TECHTRADE LLC C/O Dr. Arthur M. Horowitz Arthur M. Horowitz & Associates, Incorporated 11900 Gainsborough Road Potomac, Maryland 20854-3305 Re: K042145 Trade/Device Name: Ready Heat™ Blanket Regulation Number: 880.6060 Regulation Name: Medical Disposable Bedding Regulatory Class: I Product Code: KME Dated: September 1, 2004 Received: September 2, 2004 Dear Dr. Horowitz: We have reviewed your Section 510(k) premarket notification of intent to market the device we nate reviewed young young 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 intersule commerce proves that have been reclassified in accordance with the provisions of Amendinons, or to act read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions was 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 (1 Nr.), It may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 -Dr. Horowitz Please be advised that FDA's issuance of a substantial equivalence determination does not I Toast be authout that 12 a determination that your device complies with other requirements mean that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal state s requirements, including, but not limited to: registration 1 ou must comply with and 07); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 OF R Part 807), 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. This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter while are n your end finding of substantial equivalence of your device to a premaired predicated. - I 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), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may overn 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/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ K042145 ## Indications for Use 510(k) Number: (if known): K042145 Device Name: Ready Heat™ blanket Indications for Use: To provide warm relief 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-CONTINUNE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Rander R. Sluy for ADW 9/16/04 (Division Sign-Off) Division of Anesthesiology, General Ho Infection Control. Denta 510(k) Number: K042145