Kogniz, Inc.

Warning LetterClosed

Jed Putterman Kogniz, Inc. 225 Miller Avenue Building B Mill Valley , CA 94941 United States jed@kogniz.comIssued Mar 4, 2021Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Kogniz, Inc.
Location: Jed Putterman Kogniz, Inc. 225 Miller Avenue Building B Mill Valley , CA 94941 United States jed@kogniz.com
FEI Number: N/A
Country: United States
Issue Date: March 04, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Closed
Closeout Letter: August 30, 2024

Summary

Kogniz, Inc. was warned for offering the KOGNIZ TC20, a telethermographic device for measuring human body temperature, for sale in the United States without required FDA marketing approval, clearance, or authorization. The product violated the Federal Food, Drug, and Cosmetic Act by lacking an approved premarket approval (PMA) application or investigational device exemption (IDE), making it adulterated, and by failing to submit a 510(k) notification before introducing it into interstate commerce, rendering it misbranded. The FDA identified that such telethermographic devices present potentially serious public health risks, including the possibility of incorrectly detecting normal body temperature.