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FDA 510(k)

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

K-Number: K222588 · 2023-02-17

ApplicantIweecare Co., Ltd.
Decision Date2023-02-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is the device name listed in this FDA 510(k) record. The listed applicant is Iweecare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K222588. 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 (Smart Thermometer Patch) Model Number: STP-MB01-1?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Iweecare Co., Ltd.. The 510(k) number is K222588.

When did Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 receive FDA 510(k) clearance?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 received FDA 510(k) clearance on 2023-02-17, under 510(k) number K222588.

Who is the listed applicant for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

The FDA 510(k) record lists Iweecare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

The FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is FLL.

Related Clinical Trials

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Other records listing Iweecare Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202603Temp Pal

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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.

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