K222588 is an FDA 510(k) clearance for the Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1. This device is classified as a Continuous Measurement Thermometer (Class II - Special Controls, product code FLL).
Submitted by Iweecare Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on February 17, 2023, 175 days after receiving the submission on August 26, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2910. A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf..
| 510(k) Number | K222588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2022 |
| Decision Date | February 17, 2023 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLL - Continuous Measurement Thermometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2910 |
| Definition | A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf. |