DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200

K070491 · K-Jump Health Co., Ltd. · FLL · Jun 21, 2007 · General Hospital

Device Facts

• Record ID: K070491
• Device Name: DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
• Applicant: K-Jump Health Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The devices are intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.

Device Story

Digital Forehead Thermometer, Model KD-2200, measures human body temperature via forehead. Device utilizes probe with thermistor sensor and stainless steel plate to detect temperature changes; electronic signals processed by ASIC circuit on PC board; output displayed on LCD. Device intended for adult and pediatric use; operated by user to obtain temperature readings. Benefits include non-invasive, intermittent temperature monitoring. Device is handheld, battery-powered (two AAA batteries), and includes buzzer for alerts.

Clinical Evidence

Bench testing only. Device complies with ASTM E1112-00 (Electronic Thermometer for Intermittent Determination of Patient Temperature), EN 60601-1-2, and EN 60601-1 standards.

Technological Characteristics

Handheld electronic thermometer. Components: probe with thermistor sensor and stainless steel plate, ASIC circuit on PC board, LCD display, plastic housing, buzzer, two AAA batteries. Standards: ASTM E1112-00, EN 60601-1-2, EN 60601-1.

Indications for Use

Indicated for adult and pediatric patients for the measurement of human body temperature via the forehead.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Up-grade Forehead Thermometer (K032362)

Submission Summary (Full Text)

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K07 0491

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# JUN 2 1 2007

#### EXHIBIT 11

### 510(k) Summary

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Daniel Tsenq K-jump Health Co., Ltd. No. 56 Wu Kung 500 Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386

Date Prepared: Feb. 14, 2007

### Name of Device and Name/Address of Sponsor

Digital Forehead Thermometer, Model KD-2200

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person : Danny Wanq

| Common or Usual Name | Clinic Thermometer |
|----------------------|----------------------------------------------------------|
| Classification Name | Class II §880.2910 Clinical Electronic<br>Thermometer |
| Predicate Device | Up-grade Forehead Thermometer,<br>K#032362, Medisim Ltd. |

## Intended Use/Indications for Use

The devices are intended to measure the human body

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temperature using the forehead as measurement site. It can be used with adult or pediatric patients.

K070491

### Technology Characteristics

The Digital Forehead Thermometer, Model KD -2200, consists of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature. The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing. The electronic signal was transferred to ASIC circuit on PC board through sensor of probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement.

#### Performance Data

The Digital Forehead Thermometer, Model KD-2200 complies with the ASTM E1112-00(Reapproved 2006) "Electronic Thermometer for Intermittent Determination of Patient Temperature" standard, EN 60601-1-2 (2001) and EN 60601-1(1997).

### Substantial Equivalence

The device is substantially equivalent to Up-grade Forehead Thermometer, K#032362. The device is share the same intended use an indication for use with the exception of small differences in their temperature measurement ranges, minimum operational temperature and humidity, minimum storage temperature and humidity, both devices are technologically identical.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Danny Wang Quality Representative K-jump Health Company, Limited No. 56 Wu Kung 5th Road Wu Ku Industrial Park, Taipei Hsien TAIWAN 248

JUN 2 1 2007

Re: K070491

Trade/Device Name: Digital Forehead Thermometer, Model KD-2200 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermoter Regulatory Class: II Product Code: FLL Dated: June 15, 2007 Received: June 18, 2007

Dear Mr. Wang:

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.

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Page 2 -- Mr. Wang

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

#### Enclosure

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K070491

#### EXHIBIT A

## Indications for Use

510(k) Number (if Known):

Device Name: Digital Forehead Thermometer, Model KD-2200

#### Indication for Use:

The Diqital Forehead Thermometer, Model KD-2200 is intended to measure the human body temperature using the forehead as measurement site. It can be used with adult or pediatric patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

OR Over-The-Counter Use_ v

C

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Kony 41