Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 (K222588)
Description
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 by Iweecare Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
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Predicate lineage for K222588
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 (K222588) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202603 | Temp Pal | Iweecare Co., Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024 |
Trace the full predicate network for K222588
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.