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WARNING LETTER

SeniorLife Technologies, Inc. MARCS-CMS 707021 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Ashok Roy
Recipient Title
President
SeniorLife Technologies, Inc.

1400 112th Ave., SE, Ste 100
Bellevue, WA 98004
United States

ash.roy@seniorlife.io
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS #707021

August 21, 2025

Dear Mr. Roy:

During an inspection of your firm located in 1400 112th Ave., Bellevue, WA 98004, FEI #3027535342, from March 24, 2025, through March 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures SeniorLife.AI. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Unapproved Device Violation

Our inspection revealed that your SeniorLife.AI mobile application is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The SeniorLife.AI mobile application is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(1).

Specifically, you registered your device under 21 CFR 890.5360 Measuring Exercise Equipment. However, the evidence indicates that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5360 Measuring Exercise Equipment, and that your device is outside the scope of this regulation. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Your firm is distributing SeniorLife.AI for a different intended use, namely the use of artificial intelligence-based algorithms to screen and “pre-diagnose” mobility and cognitive health conditions. Examples from the SeniorLife Technologies, Inc. website (https://www.seniorlife.ai/) include:

  • “Age Smarter – AI Agents for mobility and cognitive health - built for seniors, their families and care providers.”
  • “…Proven to reduced [sic] Fall [sic] by 58% in a 2-year Japanese study.”
  • Mobility Health Agent – Proactively identifies fall risk, recommends interventions, and continuously tracks patient mobility over time.
  • Cognitive Health Agent – Conducts a 5-minute gaze-based test on an iPad to detect early signs of Alzheimer’s — fast, non-invasive, and scalable.
  • “Results — The server-based AI models analyze these input to assess risks and recommend therapies.”
  • One of your FAQ responses says, “Our AI enabled computer vision software can assist a caregiver to perform these tests that provide a quick pre-diagnosis.”
  • “TUG or Timed-up-Go test is an enhanced gait & balance test. It’s typically used to assess frailty and risk of fall. Traditional measurement is the time taken by an older adult to get up from the chair, walk 10 ft (= 3m), and walk back to the chair. Our AI models can measure as many as 7 different parameters.”
  • “Gait and balance test – This test measures several irregularities in walking, balance and even movements of head of an older adult that can be early predictors of Alzheimer’s.”

Use of artificial intelligence-based algorithms to screen and diagnose mobility and cognitive health conditions, including Alzheimer’s, are diagnostic functions that are not the same as measurement of exercises. Performing proprietary analyses of patient data for the screening and diagnosis of specific conditions or disorders represents a new intended use compared to use in rehabilitation or physiotherapy to provide or facilitate exercise rehabilitation and to include exercise measurement capabilities, such as for redevelopment of muscles for restoration of motion and providing accompanying measurement of range of motion. Because there is evidence that SeniorLife.AI is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5360, it does not fall within the scope of that regulation and requires a premarket submission prior to marketing.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourD evice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that SeniorLife Technologies, Inc. cease any activities that result in the misbranding or adulteration of SeniorLife.AI, such as the commercial distribution of the device for the uses discussed above.

Quality System Regulation Violations

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We have not received your firm’s response concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to your firm on March 26, 2025. These violations include but are not limited to the following:

1. Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR § 820.100(a).

For example, your firm has not established procedures for implementing corrective and preventive actions.

2. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a).

For example, your firm has not established procedures for handling complaints. The investigator reviewed your complaint files and noted that they were not adequately evaluated to determine if an investigation was needed or whether the complaints should be reported to the FDA under Part 803, Medical Device Reporting, as noted by these examples:

a. Your firm filed Complaint (b)(4) on (b)(4) to change the test instructions for your software application to examine based on age, device usage, and disease conditions. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting. This complaint remains open and was unresolved during the inspection.

b. Your firm filed Complaint (b)(4) on (b)(4), which was closed on 7/10/23. The complaint is about a camera orientation bug where the camera stays in portrait mode when the app is opened, and the phone is turned horizontally. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting.

c. Your firm filed Complaint (b)(4) on (b)(4), which was closed on 7/10/23. The issue is regarding a request to change the application after visiting a customer to demonstrate the software application. There were changes such as analyzing Timed Up and Go (TUG) tests, creating reports, and developing specifications for saving data without being overwritten, raising concerns about the quality, reliability, and performance of the software. It is unclear if a proper investigation was conducted to determine the root cause(s) and if it was evaluated for MDR reporting.

These examples show that your firm has not established a procedure for handling complaints which increases the likelihood complaints will not be collected and analyzed in a manner that provides a valid quality data source and identification of potential nonconformances and compromises other activities such as corrective and preventive actions.

3. Failure to establish procedures for quality audits, as required by 21 CFR § 820.22.

For example, your firm has not established procedures for conducting quality audits and has not performed a quality audit since it was established in 2022, despite engaging in medical device operations.

4. Failure to establish procedures for training and identifying training needs, as required by 21 CFR § 820.25(b).

For example, your firm has not established training procedures and have not conducted training or kept training records to ensure employees perform their assigned responsibilities.

Medical Device Reporting (MDR) Violations

Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. During the inspection, Mr. Ashok Roy, President, and Ms. Shoko Hoshi, Co-Founder and Product Designer, acknowledged that your firm has not developed a written MDR procedure.

A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.

Labeling Violation

In addition, your device is further misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), which provides that a product is misbranded when its labeling is false or misleading in any particular, because your product’s website includes false and misleading representations, as described below:

  • Representations on and available through your website create an impression of official approval of the device and other potential endorsement by FDA and are false and misleading. The Apple and Android store app links on your website lead to the digital marketplaces from where purchasers can download the software. The images on those digital storefronts include the FDA logo. Further, the language “FDA Approved” appears in those same places. Your product has not received premarket approval from FDA so that representation is false. Your website also contains a statement “FDA Certified,” which is both false and misleading because FDA has not “certified” your device. The display of the FDA logo near images of and information about the products, as well as statements of FDA approval or certification, are misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA. In addition to those implications, the use of the logo is in violation of FDA’s logo policy, which can be found on our website: https://www.fda.gov/about-fda/website-policies/fda-name-and-logo-policy.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Establishment Assessment Team 3 Acting Assistant Director, Jeffrey Wooley, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 707021” when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Charles J. Chacko, via email at charles.chacko@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,
/S/

Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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