FLEXIBLE TIP DIGITAL THERMOMETER

{0}------------------------------------------------ 1974195 510(k) Flexible Tip Digital Thermometer K-Jump Health Co., Ltd. PAGE 70 ## 510(k) Summary | Proprietary Name: | Flexible Tip Digital Thermometer | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Digital Thermometer with Flexible Tip | | Classification: | Class II | | Submitter Details: | Polygreen Company, Ltd.<br>a subsidiary of K-Jump Health Co. Ltd.<br>136 Wu Kung Road, Wu Ku Industrial Park<br>Taipei, Hsien<br>Taiwan, R.O.C.<br>Tel: 011-886-2-2991378-82<br>Fax: 011-886-2-2991386<br>Contact: Mr. Tseng Chao Man (Daniel) | The Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The Flexible Tip Digital Thermometer is substantially equivalent to PolyMedica Corporation's Flexible Tip Digital Thermometer. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services in the USA. The logo features a stylized eagle or bird-like figure composed of three curved lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 **FEB 4 1998** Mr. Robert J. Zappa President K-Jump Health Company, Ltd. C/O Polymedica Healthcare, Incorporated 581 Conference Place Golden, Colorado 80401 Re : K974195 Flexible Tip Digital Thermometer Trade Name: Regulatory Class: II Product Code: FLL Dated: October 29, 1997 Received: November 7, 1997 Dear Mr. Zappa: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {2}------------------------------------------------ Page 2 - Mr. Zappa through 542 of the Act for devices under the Electronic enrough Sadiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in your can equivalence of your device to a legally marketed predicate device results in a classification for your markets 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general …… : information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## PREMARKET NOTIFICATION ## INDICATIONS FOR USE STATEMENT | 510(k) Number: | Unassigned<br>K-Jump Health Co., Ltd. | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Flexible Tip Digital Thermometer | | Indications for Use: | The Flexible Tip Digital Thermometer is a non-sterile, reusable<br>clinical thermometer intended for the determination of oral,<br>rectal, and axillary body temperature determination of humans. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) NAVA Concernes of Co . (Division Sign-Off) Division of Dental, Into otion Control. and General He 9470 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Countar Use__________________________________________________________________________________________________________________________________________________________ (Optional Formal 1-2,96)..... . ..............................................................................................................................................