FDA 510(k)

Temp Pal

K-Number: K202603 · 2021-07-22

Decision Date2021-07-22

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Temp Pal is a medical device manufactured by Iweecare Co., Ltd.. It received FDA 510(k) clearance on 2021-07-22 under approval number K202603. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Temp Pal?

Temp Pal is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Iweecare Co., Ltd.. The 510(k) number is K202603.

When was Temp Pal approved by the FDA?

Temp Pal received FDA 510(k) clearance on 2021-07-22, under approval number K202603.

What company makes Temp Pal?

Temp Pal is manufactured by Iweecare Co., Ltd..

What is the FDA product code for Temp Pal?

The FDA product code for Temp Pal is FLL.

Other Devices by Iweecare Co., Ltd.

K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.