HUANQIU HEATING LAMP

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the text "Crosslinks International, Inc." in a serif font. The text is arranged in two lines, with "Crosslinks" on the first line and "International, Inc." on the second line. The text is black and the background is white. The image appears to be a logo or heading from a document. # 510 (k) Premarket Notification Summaries ### Submission Correspondent George Su, Ph.D. Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA Tel: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000/a aol.com ## Applicant: A & A MEDICAL SUPPLIES INC 5288 valley blvd #1 Los Angeles, CA 90032 Tel: 323-223-6318 # Sponsor of the 510(k) Submission: Same as above. # Device Name: Proprietary Name: HUANQIU Heating Lamp Common/Usual Name: Infrared Lamp Device Name: Infrared Lamp Product Code: ILY Classification: Class II # Predicate Device: TDP CQ-27 Heat Lamp Establishment: LHASA Medical Inc. Regulation Number: 890.5500 Product Code: ILY 510(k) Number: K003538 Registration Number: 1222811 Owner/Operator Number: 9003816 {1}------------------------------------------------ Crosslinks International, Inc. ### Description of the HUANQIU Heating Lamps: The device consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control. ### Indications for use HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. #### Substantial Equivalence Information HUANQIU CQ-27, CQ-29 and CQ-67 Heating Lamps are generally equivalent to CQ-27 Heat Lamp (K003538) manufactured by Lhasa Medical, Inc. on label and labeling, materials used, specifications and intended use. All the technical data are tested according to GB 9706.1-1995 which is identical to IEC 60601-1 The equivalence information is focused on intended use, materials and specifications. HUANQIU Heating lamps are powered by 110V AC, They have 4 or 5 casters and 2 fuses. The working life of the heating plate is 1000 to 1500 hours. The skin temperature of the treatment area is at 40~45℃ when treating distances are from 8" to 12" from heating unit to treatment surface. {2}------------------------------------------------ Crosslinks International, Inc. Table 1. Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The new device: HUANQIU Heating Lamp CQ-27 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | | and and and the commend the production of the first of the first of the first of the first of the first of the may | | Item | The predicate device | The new device | | | |----------------------|------------------------------------------------------------------|------------------------------------------------------------------|--------------|------------| | Components | heating head, swing arm, control box and pedestal with extension | heating head, swing arm, control box and pedestal with extension | | | | Power Frequency | 50/60 Hz | 50/60 Hz | | | | Power | $\leq 250 W$ | $\leq 250 W$ | | | | Spectrum Ranges | 2 to 50 microns | 2 to 50 microns | | | | Warming Up Time | 15 minutes | 15 minutes | | | | Total Working Hours | 1,200 to 1500 hours | 1,000 to 1500 hours | | | | Operating Timer | Up to 60 minutes | Up to 60 minutes | | | | Number of Fuse | 2 | 2 | | | | Inner Cover Diameter | 12 cm | 12 cm | | | | Number of Casters | 4 | 4 | | | | Skin Temperature | The distance from the lamp head and the result | | | | | | 8"<br>45°C | 10"<br>43 °C | 12"<br>41 °C | 8"<br>45°C | Table 2. Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: HUANQIU Heating Lamp CQ-29 | Item | The predicate device | The new device | | | |----------------------|------------------------------------------------------------------|------------------------------------------------------------------|-------------|------------| | Components | heating head, swing arm, control box and pedestal with extension | heating head, swing arm, control box and pedestal with extension | | | | Power Frequency | 50/60 Hz | 50/60 Hz | | | | Power | < 250 W | < 250 W | | | | Spectrum Ranges | 2 to 50 microns | 2 to 50 microns | | | | Warming Up Time | 15 minutes | 15 minutes | | | | Total Working Hours | 1,200 to 1500 hours | 1,000 to 1500 hours | | | | Operating Timer | Up to 60 minutes | Up to 60 minutes | | | | Number of Fuse | 2 | 2 | | | | Inner Cover Diameter | 12 cm | 20 cm | | | | Number of Casters | 4 | 4 | | | | Skin Temperature | The distance from the lamp head and the result | | | | | | 8"<br>45°C | 10"<br>43°C | 12"<br>41°C | 8"<br>45°C | {3}------------------------------------------------ Crosslinks International, Inc. Table 3. Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: HUANQIU Heating Lamp CQ-67 | Item | The predicate device | The new device | |----------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Components | heating head<br>swing arm<br>standard control box<br>pedestal with extension | heating head<br>swing arm<br>control box with digital display<br>pedestal with extension | | Power Frequency | 50/60 Hz | 50/60 Hz | | Power | < 250 W | < 250 W | | Spectrum Ranges | 2 to 50 microns | 2 to 50 microns | | Warming Up Time | 15 minutes | 15 minutes | | Total Working Hours | 1,200 to 1500 hours | 1,000 to 1500 hours | | Operating Timer | Up to 60 minutes | Up to 60 minutes | | Number of Fuse | 2 | 2 | | Inner Cover Diameter/width | 12 cm | 30 cm | | Number of Casters | 4 | 5 | | Skin Temperature | The distance from the lamp head and the result | | | | 8"<br>45 | 10"<br>43°C | | | 12"<br>41°C | 8"<br>46 °C | | | 10"<br>42°C | 12"<br>40°C | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The seal is in black and white. SEP 3 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 A & A Medical Supplies Inc. c/o George Su, Ph.D. Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, California 90067 Re: K052063 Trade/Device Name: Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 4, 2005 Received: July 29, 2005 Dear Dr. Su: 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. {5}------------------------------------------------ Page 2 - George Su, Ph.D. 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) 276-0120. 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 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, Mark A. Milliman Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Premarket Notification 510(k) Report for HUANQIU HEATING LAMP # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. 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 OF NEEDED) Mark A. Millkerson (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K052063