← Product Code [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) · K043331 # DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 (K043331) _Hubdic Co., Ltd. · FLL · Mar 4, 2005 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K043331 ## Device Facts - **Applicant:** Hubdic Co., Ltd. - **Product Code:** [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL.md) - **Decision Date:** Mar 4, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use The Digital Forehead Thermometer FS-100 is an infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages. ## Device Story Hand-held, battery-operated infrared thermometer; measures natural thermal infrared radiation emitted from skin surface over temporal artery. Used for intermittent body temperature measurement in patients of all ages. Operated by clinicians or patients in clinical or home settings. Provides temperature reading to user to assist in clinical decision-making regarding patient health status. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate. ## Technological Characteristics Hand-held, battery-operated infrared thermometer. Sensing principle: detection of natural thermal infrared radiation from the temporal artery. Form factor: portable electronic device. No specific materials or software algorithm class specified. ## Regulatory 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 - Exergen Corporation Temporal Scanner Thermometer ([K011291](/device/K011291.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K093331 MAR 4 - 2005 Pg. 1 of 2 Image /page/0/Picture/3 description: The image shows the letters 'MTC' in a bold, serif font. The letters are large and black, contrasting with the white background. The letters are slightly slanted to the right, giving the image a dynamic feel. The overall impression is clean and professional. Media Trade Corporation 11820 Red Hibiscus Drive -- Bonita Springs, FL 34135 Tel (239) 948-2001 - Fax (239) 948-2002 E-mail: mediatradecorplagmx.net ## 510(k) Summary | Submitter's Name: | Guenter Ginsberg
Media Trade Corporation | |--------------------|------------------------------------------------------------------------------------------------------------------------------------| | Address: | 11820 Red Hibiscus Drive
Bonita Springs, FL 34135 | | Phone: | (239) 948-2001 | | Fax: | (239) 948-2002 | | E-mail: | mediatradecorp@gmx.net | | Contact: | Guenter Ginsberg | | Date of Summary: | May 7, 2004 | | Trade Name: | Digital Forehead Thermometer FS-100 | | Classification: | Thermometer, Clinical, Electronic
Product Code: FLL
Regulation Number: 880.2910
Class: II
Panel: 80 (General Hospital) | | Predicate Devices: | Exergen Corporation
Temporal Scanner Thermometer
K 011291 (Predicate) | {1}------------------------------------------------ KC43331 Pg 2 of 2 ## The Digital Forehead Thermometer FS-100 is a Device Description: hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery. The Digital Forehead Thermometer FS-100 is an Intended Use: infrared thermometer intended for the intermittent measurement of human body temperature of people of all ages. The Digital Forehead Thermometer FS-100 has Technological Characteristics: the same general design and performance characteristics as the predicate device from Exergen Corpporation. The main difference is the physical size, shape and weight. The Digital Forehead Thermometer FS-100 has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness. This submitter concludes that the Digital Forehead Thermometer FS-100 is therefore substantially equivalent to the predicate device from Exergen. Page -2- (510k Summary) {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 4 - 2005 Hubdic Company Limited C/O Mr. Guenter Ginsberg Official Correspondent Media Trade Corporation 11820 Red Hibiscus Drive Bonita Spring, Florida 34135 Re: K043331 Ro45531 Trade/Device Name: Digital Forehead Thermometer FS-100 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 2, 2005 Received: February 7, 2005 Dear Mr. Ginsberg: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becales as a see is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in Indications for use stated in the ensiblem 76, 1976, the enactment date of the Medical Device mierstate commerce pror to way been reclassified in accordance with the provisions of Amendinents, or to de rood also metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, listing of devices, good manufacturing practice, requirements for animals against misbranding and adulteration. If your device is classified (see above) into cither class II (Special Controls) or class III II your device is classified (see as other and controls. Existing major regulations affecting (PMA), it may be subject to back adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the South no everning your device in the Federal Register. {3}------------------------------------------------ Page 2 – Mr. Ginsberg Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a substantar see complies with other requirements mean that FDA nas made a decemmandia had Jour winistered by other Federal agencies. of the Act or any Federal statutes and regulations administered by points of the posictroi of the Act or any Pederal statutes and regulations, but not limited to: registration You must comply with all the Act's requirements and the You must comply with an the Act 3 requirements and 1); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 OFF areas) / requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) I mis letter will anow you to begin marketing your alence of your device to a premarket notification. The PDF Intalling or 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 advice for your as at (240) 276-0115. Also, please note the regulation i picase contact the Office or Occipitalism promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other general meeting. International and Consumer Assistance at its toll-free Division of Six 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, Chiu Lin, Ph.D. 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K043331 Hubdic Co. Ltd., Digital Forehead Thermometer FS-100 Device Name: Indications For Use: This device is an electronic clinical thermometer using an infrared sensor to detect body I mis device is an clock one entired wer the temporal artery on the forehead. It is intended for people of all ages. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) Vick Husband for Anthony Weston Salnay, General Hospital, ) [k] Number: Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K043331](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K043331) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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