WARNING LETTER
Exer Labs, Inc.
MARCS-CMS 699218 —
February 10, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Zaw L. Thet
Recipient Title
Chief Executive Officer
Exer Labs, Inc.
383 Corona Street
Denver
,
CO
80218
United States
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
February 10, 2025
Dear Mr. Thet:
During an inspection of your firm located in Denver, CO on October 17, 2024, through October 24, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Exer Scan. 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 any function of the body.
FDA has reviewed the Exer Labs, Inc. website (https://www.exer.ai) and determined that the Exer Scan is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Exer Scan 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).
Devices classified under 21 CFR 890.5360 Measuring Exercise Equipment are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). Generic devices of this type are intended to provide or facilitate exercise rehabilitation and include exercise measurement capabilities. However, your firm is marketing the Exer Scan for an intended use different from the use allowed by the exemption, namely the use of artificial intelligence-based algorithms to screen, diagnose, and treat musculoskeletal and neurological disorders. Examples include:
From the Exer Labs, Inc. website (https://www.exer.ai/)
• “Use Clinical AI to Diagnose and Treat MSK Disorders”
• “AI-Based Screening for MSK Disorders in Neurology – Screen and treat patients with Parkinson’s, TB, Cerebral Palsy and more using AI and computer vision…”
• “AI-Based MSK Detection & Treatment for Primary Care”
• “The Operating System for Hybrid Orthopedic Care – Automate treatment pathways for operative or conservative care to reduce complications…”
• “The Operating System for MSK in Senior Care – Screen and treat Medicare and Medicaid patients across residential communities to prevent falls…”
Use of artificial intelligence-based algorithms to screen and diagnose musculoskeletal or neurological disorders, including Parkinson’s, musculoskeletal tuberculosis, and cerebral palsy are diagnostic functions that are not limited to 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. The claims identified above are intended uses that are different from those of legally marketed devices classified under 21 CFR 890.5360 and mean that the device is not exempt from premarket notification.
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/HowtoMarketYourDevice/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 Exer Labs, Inc. cease any activities that result in the misbranding or adulteration of the Exer Scan, such as the commercial distribution of the device for the uses discussed above.
This inspection also revealed that this device is 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 received a response from you dated November 13, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately establish procedures for design controls as required by 21 CFR 820.30(a).
For example, your firm has not established procedures for design controls. Your firm has designed, marketed, and distributed the Exer Scan device and you have not established design control procedures for the Exer Scan.
The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a design control system with an expected completion date by February 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.
2. Failure to 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 adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a complaint system with an expected completion date by January 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.
3. Failure to adequately establish procedures for corrective and preventive actions as required by 21 CFR 820.100(a).
For example, your firm has not established procedures for corrective and preventive actions.
We reviewed your firm’s response and concluded that it is not adequate. Your response includes an action plan for establishing a CAPA system through February 2025. Your response also includes new procedures: however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions. Furthermore, your response does not include a retrospective review of previous quality problems to evaluate if CAPAs should be open. For example, your firm received a complaint involving the failure of a software update to automatically update. In response, your firm made design changes to your device. As part of your corrective actions, your firm should evaluate if a CAPA should be opened for this corrective action to ensure systemic corrective actions have been taken.
4. Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50.
For example, your firm has not established procedures for purchasing controls. Your Chief Technology Officer reported your firm has
(b)(4)
suppliers associated with your device. Your firm has not established purchasing controls for either of these suppliers.
We have reviewed your firm’s response and determined it is not adequate. Your firm’s response provides a general corrective action plan for establishing and implementing purchasing control procedures to be completed by March 2025. However, your response does not include any procedures or adequately detailed description of planned procedures to allow for assessment. Additionally, although you reported to product suppliers during the inspection, you should evaluate if you have suppliers of any services for which purchasing controls may also apply, as 21 CFR 820.50 applies to suppliers of products and services.
5. Failure to establish procedures for management review as required by 21 CFR 820.20(c).
For example, your firm has not established procedures for management review and your firm has not conducted management reviews since your firm has been in operation.
The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a management review system with an expected completion date by March 2025. Your response also includes new procedures; however, we cannot assess the implementation of these procedures at this time due to your ongoing corrective actions.
6. Failure to establish procedures for quality audits as required by 21 CFR 820.22.
For example, your firm has not established procedures for quality audits and your firm has not conducted a quality audit since it has been in operation.
We have reviewed your response and determined it is inadequate. Your response provides a corrective action plan for developing a quality audit system with an expected completion date by March 2025. The corrective action plan references 21 CFR 820.86, Acceptance Status, multiple times. It is unclear if this was in oversight or an intentional reference in your plan. The requirements for quality audits are described in 21 CFR 820.22.
7. 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 has not maintained records of training reported as being provided to staff.
The adequacy of your response cannot be determined at this time. Your response provides a corrective action plan for developing a training system with an expected completion date by February 2025. However, your firm has not provided procedures or an adequately detailed description of planned procedures to allow for assessment.
A follow up inspection will be required to verify that corrections and/or corrective actions are adequate.
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 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 Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Jessica Mu, Assistant Director. Refer to the Unique Identification Number CMS 699218 when replying. If you have any questions about the contents of this letter, please contact: Jeff Wooley, Compliance Officer at 214-253-5251 or jeffrey.wooley@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 any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/
for RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/25/2025
Regulated Product(s)
Medical Devices