Summary of Withings Thermo SCT01 User Manual
The Withings Thermo (Model SCT01) is a Clinical Electronic Thermometer intended for measuring human body temperature. On June 17, 2016, the Food and Drug Administration (FDA) issued a letter to Tony Chang of Wincent Consultant Co., Ltd., acknowledging the receipt and clearance of the premarket notification for the Withings Thermo, which complies with the necessary regulatory requirements under 21 CFR 880.2910.
Device Overview
The letter from the FDA classifies the Withings Thermo as a Clinical Electronic Thermometer under the product code FLL. It is subject to general controls, which include annual registration, device listing, good manufacturing practice, appropriate labeling, and prohibitions against misbranding and adulteration. Moreover, the FDA clarifies that while the device’s labeling must be truthful and non-misleading, the FDA does not evaluate information related to contract liability warranties.
Market Clearance and Regulations
The Withings Thermo has been determined to be substantially equivalent to legally marketed predicate devices that were available prior to May 28, 1976, the enactment date of the Medical Device Amendments, or those reclassified in accordance with the Federal Food, Drug, and Cosmetic Act. This equivalence permits marketing of the device, subject to the terms outlined by the FDA.
If the device is classified into either class II or class III, which encompasses Special Controls and Premarket Approval (PMA), respectively, it may be subjected to additional controls. Relevant regulations for class II and III devices are outlined in the Code of Federal Regulations, Title 21, Parts 800 to 898. Moreover, the FDA reserves the right to publish further announcements concerning the device in the Federal Register.
Additional Information
The user manual likely contains specific instructions on the use, maintenance, and understanding of the Withings Thermo SCT01, including technical specifications, operating procedures, safety warnings, and customer support information. However, the analysis provided is based only on the first two pages of the user manual, which primarily covers regulatory and clearance information provided by the FDA.
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Download: Withings Thermo (Model SCT01) User Manual
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