SeniorLife Technologies, Inc.

Warning LetterOpen

Ashok Roy President SeniorLife Technologies, Inc. 1400 112th Ave., SE, Ste 100 Bellevue , WA 98004 United States ash.roy@seniorlife.ioFEI 3027535342Issued Aug 21, 2025Center for Devices and Radiological Health

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Violations8

Issue DateAug 21, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: SeniorLife Technologies, Inc.
Location: Ashok Roy President SeniorLife Technologies, Inc. 1400 112th Ave., SE, Ste 100 Bellevue , WA 98004 United States ash.roy@seniorlife.io
FEI Number: 3027535342
Country: United States
Issue Date: August 21, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

SeniorLife Technologies, Inc. was cited for distributing SeniorLife.AI, a mobile application classified as a medical device intended for disease diagnosis or treatment, without required premarket approval (PMA) or an investigational device exemption (IDE). The company failed to submit a 510(k) notification to the FDA before commercializing the device and incorrectly registered it under a measuring exercise equipment classification that did not match its actual intended use. The device was found to be adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act, with an FDA inspection conducted at the firm's Bellevue, Washington facility from March 24–26, 2025.

SeniorLife Technologies, Inc. FDA Warning Letter, August 21, 2025