510(k) K222588
K222588 is an FDA 510(k) premarket notification submitted by Iweecare Co., Ltd. for the device "Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1". The FDA issued a decision of Substantially Equivalent on Feb 17, 2023. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Iweecare Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2023
- Date Received
- Aug 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Measurement Thermometer
- Device Class
- Class II
- Regulation Number
- 880.2910
- Review Panel
- HO
- Submission Type
- 510(k)
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.