Terms of Use – Exer Scan
Effective Date: December 15, 2025
1. Introduction and Acceptance of Terms
Welcome to Exer Labs, Inc. (“Exer Labs,” “we,” “us,” or “our”). These Terms of Use (“Terms”) govern your
access to and use of Exer Scan, including the Exer Scan mobile application, software, algorithms,
firmware, documentation, reports, dashboards, and related services (collectively, the “Services”).
Exer Scan is intended for professional, clinical, or operational use as described below.
By accessing or using Exer Scan, you acknowledge that you have read, understand, and agree to be
bound by these Terms, our Privacy Policy, the Instructions for Use (IFU), and any additional policies
incorporated by reference (collectively, the “Agreement”). If you do not agree, you may not use Exer
Scan.
THIS SOFTWARE IS REGULATED AS A MEDICAL DEVICE. USE OF THIS SOFTWARE FOR MEDICAL PURPOSES
WITHOUT PROPER AUTHORIZATION MAY VIOLATE APPLICABLE LAWS AND REGULATIONS.
If you are using Exer Scan on behalf of a healthcare provider, senior living organization, employer, or
other entity, you represent and warrant that you are authorized to bind that entity to these Terms.
Company Contact Information
Company: Exer Labs, Inc.
Product: Exer Scan (Software as a Medical Device)
Address: 1873 South Bellaire Street, Suite 1420, Denver, CO 80222
Email: support@exerai.com
2. Regulatory Status and Intended Use (Exer Scan SaMD Disclosure)
Regulatory Status
Exer Scan is a Software as a Medical Device (SaMD) registered with the U.S. Food and Drug
Administration (FDA) as a Class II medical device and is 510(k)-exempt, subject to applicable FDA
regulations and guidance, including but not limited to:
● 21 CFR Part 820 (Quality Management System Regulation – QMSR)
● 21 CFR Part 803 (Medical Device Reporting – MDR)
● FDA guidance on Software as a Medical Device (SaMD), Clinical Decision Support (CDS),
cybersecurity, and post-market surveillance
Intended Use
Exer Scan is intended to capture, analyze, and present movement and functional performance data to
support qualified users in:
● Functional and mobility assessments
● Fall risk–related screening and monitoring
● Objective measurement to inform clinical decision-making
Exer Scan is intended to be used only by trained users in clinical, institutional, or supervised care
environments and only in accordance with the Instructions for Use (IFU).
Clinical Decision Support (CDS) Limitations
- Exer Scan provides supporting information only.
- It does not independently diagnose conditions, prescribe treatment, or predict patient outcomes.
- Outputs must be reviewed, interpreted, and validated by a qualified human user before any clinical or
operational decision is made.
3. Professional Use Only; No Emergency Use
Exer Scan is intended for professional use only and is not designed for unsupervised consumer use.
THE SERVICES ARE NOT FOR EMERGENCY USE AND MUST NOT BE USED FOR:
● Emergency diagnosis or triage
● Life-sustaining or time-critical clinical decisions
If an emergency is suspected, users must immediately follow standard clinical protocols and contact
emergency services (911 in the U.S.).
4. User Qualifications and Responsibilities
You represent and warrant that:
● You are a healthcare professional, trained staff member, or authorized user operating under
appropriate clinical or organizational supervision.
● You have completed required Exer Scan training and onboarding.
● You will use Exer Scan strictly within its intended use and IFU.
● You will comply with all applicable laws, regulations and professional standards.
You are solely responsible for:
● Independent review and validation of all Exer Scan outputs
● Ensuring patient appropriateness, consent, and safety. Exer Labs disclaims any liability for patient
care, outcomes, appropriateness, consent, or safety.
● Compliance with licensure, scope-of-practice, and facility policies
5. Data Inputs, Environment, and Accuracy Dependencies
The performance of Exer Scan depends on correct:
● Device setup and calibration
● Environmental conditions
● User positioning and workflow adherence
● Accurate and complete user inputs
You acknowledge that improper setup, inaccurate, incomplete, or outdated data, or misuse may result in
inaccurate or unreliable outputs. Exer Labs is not responsible for outcomes resulting from failure to
follow the IFU or training materials.
6. Software Updates, Cybersecurity, and System Integrity
To maintain safety, effectiveness, and regulatory compliance:
● Exer Labs may deploy mandatory software updates, patches, or security enhancements.
● Continued use of Exer Scan may require installation of such updates.
● Failure to install required updates may result in limited functionality or suspension of access.
You may not:
● Disable or bypass security controls
● Modify or reverse engineer Exer Scan
● Integrate unauthorized third-party software or hardware
7. Complaints, Adverse Events, and FDA Reporting
User Reporting Obligations
You agree to promptly report to Exer Labs any:
● Suspected device malfunction
● Unexpected or incorrect output
● Use error resulting in or potentially resulting in harm
● Serious injury, death, or near-miss associated with Exer Scan
Reports must be submitted to: support@exerai.com
Regulatory Reporting
Exer Labs maintains procedures to evaluate complaints and submit reports to the FDA as required under
21 CFR Part 803 (Medical Device Reporting).
Users agree to cooperate with reasonable requests for follow-up information required for safety
investigations or regulatory compliance.
8. Clinical Judgment and Responsibility
Exer Scan:
● Does not replace clinical judgment
● Does not establish a clinician–patient relationship
● Does not determine standards of care
All clinical decisions remain the sole responsibility of the qualified healthcare professional using Exer
Scan. Exer Labs disclaims any liability for clinical outcomes or misuse of the product, and the user
acknowledges that Exer Scan is a tool to assist, not replace, professional judgment.
9. Privacy, HIPAA, and Data Protection
Exer Scan may process personal data and protected health information (“PHI”). Use of Exer Scan is
subject to our Privacy Policy and, where applicable, a Business Associate Agreement (BAA).
Exer Labs implements safeguards designed to protect data confidentiality, integrity, and availability
consistent with:
● HIPAA and applicable state privacy laws
● FDA cybersecurity expectations for medical devices
You acknowledge that no system can be completely secure.
Users are responsible for maintaining secure access credentials and complying with their organization’s
privacy and security policies.
10. Prohibited Uses (Exer Scan–Specific)
You may not:
● Use Exer Scan outside its intended use or IFU
● Rely on outputs without human clinical review
● Use Exer Scan in unsupported environments or populations
● Represent Exer Scan as autonomous, diagnostic, or treatment-determining
● Alter, obscure, or remove regulatory labeling or disclosures
Exer Labs may suspend or terminate your access to Exer Scan if you violate these Terms, applicable law,
or regulatory requirements. Upon termination, you must cease all use of the Exer Scan. Additionally,
violation may result in regulatory notification where required.
11. Availability and Support.
Exer Scan may be subject to planned or unplanned downtime. Exer Labs
does not guarantee uninterrupted availability. Support services, if any, are provided as described in a
separate support or service level agreement.
12. Intellectual Property.
Exer Scan and all related intellectual property rights are and shall remain the
exclusive property of Exer Labs and its licensors. No rights are granted except as expressly stated herein.
13. Required Legal and Regulatory Disclaimers
Except as expressly required by applicable law or FDA regulation, Exer Scan is provided “AS IS” and “AS
AVAILABLE”. EXER LABS DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY,
INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, EXCEPT TO THE
EXTENT PROHIBITED BY APPLICABLE MEDICAL DEVICE LAW.
Nothing in these Terms limits rights or obligations that cannot legally be disclaimed under U.S. medical
device regulations.
14. Limitation of Liability
To the fullest extent permitted by law, Exer Labs shall not be liable for damages arising from:
● Off-label or improper use
● Failure to follow training or IFU
● Independent clinical decisions
This limitation does not apply to the extent prohibited by applicable law or regulation. Any
unenforceable portion shall not affect the enforceability of the remainder. IN NO EVENT SHALL EXER
LABS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES,
INCLUDING LOSS OF PROFITS, DATA, OR USE, ARISING OUT OF OR RELATED TO YOUR USE OF EXER SCAN.
EXER LABS’ TOTAL LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY YOU FOR EXER SCAN IN THE
TWELVE (12) MONTHS PRECEDING THE CLAIM.
15. Changes to Exer Scan or These Terms
These Terms may be updated to reflect:
● Regulatory changes
● Safety or performance improvements
● Software or cybersecurity updates
Material changes will be communicated through the Services or direct notice.
16. Governing Law and Dispute Resolution
These Terms are governed by the laws of the State of Colorado, without regard to conflict of laws
principles. Any disputes shall be resolved exclusively in the state or federal courts located in Denver
County, CO, unless otherwise agreed, or otherwise required by law.
17. Indemnification.
You agree to indemnify, defend, and hold Exer Labs and its Licensors harmless from and against any claims arising
from your, or your employees or agents misuse of Exer Scan, violation of these Terms, or use of Exer Scan
outside its intended use or IFU.
18. Severability.
If any provision of these Terms is found to be invalid or unenforceable, the remaining
provisions will remain in effective. The unenforceable provisions shall be modified to the minimum
extent necessary to make them valid without affecting the essential purpose of these Terms.
19. Acknowledgment
By using Exer Scan, you acknowledge and agree that:
● Exer Scan is a regulated Class II SaMD
● You have reviewed the IFU and required training
● You accept responsibility for appropriate professional use and acknowledge that the Exer Labs
shall not be liable for your misuse or non-compliance with regulatory requirements.
End of Terms
