# K222588: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

- Pathway: 510(k) (Traditional)
- Applicant: Iweecare Co., Ltd.
- Decided: Feb 17, 2023 after 175 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010462 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202603: Temp Pal, Iweecare Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K240333: Wearable Digital Thermometer (T31) (2024), 0 descendants of its own

## Indications for use
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.

Source page: https://510kreport.com/device/K222588
Methodology: https://510kreport.com/methodology