← Product Code [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) · K152508 # Ageless Health Medical Digital Thermometer (K152508) _Dongguan Ageless Health Industrial Co., Ltd. · FLL · Dec 31, 2015 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K152508 ## Device Facts - **Applicant:** Dongguan Ageless Health Industrial Co., Ltd. - **Product Code:** [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL.md) - **Decision Date:** Dec 31, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral). ## Device Story Digital thermometer for human body temperature measurement (oral/armpit). Input: resistance change from thermistor sensor; processed by ASIC; output: digital temperature reading on LCD. Operated by patient or clinician in home or clinical settings. Provides temperature data to assist in health monitoring. ## Clinical Evidence Bench testing only. Performance evaluated against IEC 60601-1, IEC 80601-2-56, IEC 60601-1-2, IEC 60601-1-11, ASTM E1112-00, ISO 10993-5, and ISO 10993-10. No clinical data provided. ## Technological Characteristics Thermistor-based sensing; ASIC signal processing; 1.5V button battery power; ABS plastic and stainless steel patient-contact materials; IP22 ingress protection. Standards: IEC 60601-1, IEC 80601-2-56, IEC 60601-1-2, IEC 60601-1-11, ASTM E1112-00, ISO 10993-5, ISO 10993-10. ## 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 - Electronic thermometer ([K131210](/device/K131210.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 31, 2015 Dongguan Ageless Health Industrial Co., Ltd c/o Ms. Cecilia Ceng Regulatory Manager Guangzhou Glomed Biological Technology Co., Ltd Suit 306, Kecheng Mansion. No.121 Science Road, Guangzhou Science Park Guangzhou. 510663 CHINA Re: K152508 Trade/Device Name: Ageless Health Medical Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 17, 2015 Received: November 23, 2015 Dear Ms. Ceng: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152508 ### Device Name Device Name: Ageless Health Medical Digital Thermometer Indications for Use (Describe) Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral). Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## K152508 This summary of 510(K) information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. #### 1. Submitter Information Sponsor Name: Dongguan Ageless Health Industrial Co.,Ltd. Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: +86-769-81158038 Fax: +86-769-82289331 E-mail: victor@agelh.com ## Application Correspondent: Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: regulatory@glomed-info.com #### 2. Subject Device Information | Type of 510(k): | Traditional | |----------------------|--------------------------------------------| | Common Name: | Thermometer, electronic | | Trade Name: | Ageless Health Medical Digital Thermometer | | Classification Name: | Thermometer, electronic, clinical | | Review Panel: | General Hospital | | Product Code: | FLL | {4}------------------------------------------------ Requlation Number: 880.2910 Regulation Class: 2 #### 3. Predicate Device Information Sponsor: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Classification Name: Thermometer, electronic, clinical Trade Name: Electronic thermometer 510(k) number: K131210 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: 2 #### 4. Device Description Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. #### 5. Intended Use Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral). #### 6. Test Summary Ageless Health Medical Digital Thermometer has been evaluated the performance by lab bench testing according to the following standards: {5}------------------------------------------------ - IEC 60601-1 (2005 + CORR.1:2006 + CORR.2:2007 + AM1:2012) Medical I Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - . IEC 80601-2-56 (2009) Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement - " IEC 60601-1-2 (2007) Medical Electrical Equipment - Part 1-2: Collateral Standard: Electromagnetic Compatibility - .. IEC 60601-1-11 (2010), Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used - ' ASTM E1112-00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature - . ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro cytotoxicity - l ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization The same tests on Ageless Health Medical Digital Thermometer and the predicate device demonstrate the substantial equivalence of the two. #### 7. Comparison to Predicate Device Compare with predicate device, the subject device is very similar in design principle, intended | Elements of
Comparison | Subject Device | Predicate Device | Conclusion | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------| | Company | Ageless Health Industrial Ltd. | SHENZHEN PUMP MEDICAL
SYSTEM CO., LTD. | -- | | Name and
Model | Ageless Health Medical Digital
Thermometer, models: BT-301, | Electronic thermometer, models:
TF3100, TF3101, TF3102 | -- | | Elements of
Comparison | Subject Device | Predicate Device | Conclusion | | | BT-302, BT-303, BT-305, BT-306,
BT-308, BT-311, BT-318 | | | | 510(k) Number | Applying | K131210 | -- | | Thermometer
Type | Digital Thermometer | Digital Clinical Thermometer | SE | | Intended Use | Ageless Health Medical Digital
Thermometers are intended for use
in measuring human body
temperature (Armpit or Oral). | It is intended for use in measuring
temperature in human body
(Armpit or Oral). | SE | | Indication for
Use | Ageless Health Medical Digital
Thermometers are intended for use
in measuring human body
temperature (Armpit or Oral). | It is intended for use in measuring
temperature in human body
(Armpit or Oral). | SE | | Sensor | Thermistor | Thermistor | SE | | Signal
Processing and
Display | Using the resistance change of
thermal resistor to detect body
temperature and displayed through
the LCD. | Using the resistance change of
thermal resistor to detect body
temperature and displayed
through the LCD. | SE | | Power
Requirements | 1.5V button battery | 1.5V button battery | SE | | Measurement
Temperature
Range | 32.0°C ~ 42.9°C | 32.0°C ~ 42.0°C | SE
Note 1 | | Accuracy | 35.0 ~ 39.0°C : +/- 0.1°C
The rest: +/- 0.2°C | 0.05°C (35.30 ~ 39.00°C )
0.1°C (< 35.30°C or > 39.0°C ) | SE
Note 1 | | Ambient
temperature | 10~35°C | 5~40°C | SE
Note 1 | | Response Time | 60s | 5min | SE
Note 1 | | Protection
Degree against
Ingress of Water
and Particulate
Matter | IP22 | IP22 | SE | | Patient
Contacting | ABS plastic and stainless steel | ABS plastic and stainless steel | SE | | Elements of
Comparison | Subject Device | Predicate Device | Conclusion | | Material | | | | | Complied
Standard | IEC 60601-1, IEC 80601-2-56, IEC
60601-1-2, IEC 60601-1-11, ASTM
E1112, ISO 10993-5, ISO 10993-10 | IEC 60601-1, IEC 60601-1-2, IEC
60601-1-11, ASTM E1112, ISO
10993-5, ISO 10993-10 | SE | use, indications for use, functions, material and the applicable standards. {6}------------------------------------------------ {7}------------------------------------------------ ## Note 1 Although some specifications of Measurement Temperature Range, Accuracy, and Response Time are different for subject device and predicate device, they are both complied with related performance standards. ## Conclusion The subject device Ageless Health Medical Digital Thermometer has all features of the predicate device,only with few differences(accuracy, Ambient temperature, Response Time). The technological principle is also the same with the predicate device's. Thus, the subject device is substantially equivalent to the predicate device. ## 8. Summary Prepared Date 30 December 2015 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K152508](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K152508) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com