KOTA is not a medical device and is not regulated as a medical device by the U.S. Food and Drug Administration (FDA).

KOTA does not provide medical advice, diagnosis, treatment, or clinical monitoring, and it is not a substitute for emergency response services.

KOTA relies on Bluetooth connectivity, device power, and internet or cellular networks. Ankota does not guarantee uninterrupted operation and is not responsible for failures caused by depleted batteries, loss of connectivity, environmental conditions, or third-party network outages outside its control.

KOTA provides supportive services that may include:

When KOTA is used by or on behalf of a Covered Entity (such as a home health, FMS, or HCBS provider), Ankota acts as a Business Associate under HIPAA and will execute a Business Associate Agreement (BAA) with that entity prior to service activation.

• Daily companionship through voice and smart-assistant interactions
• Safety monitoring via connected devices and sensors (e.g., Bluetooth Low Energy buttons)
• Optional integration with authorized family members, representatives, home-care agencies, and call-center partners

KOTA is intended to enhance independence and awareness. It does not replace human caregivers, emergency responders, or medical professionals.

KOTA is not a medical device and is not regulated as a medical device by the U.S. Food and Drug Administration (FDA).

KOTA does not provide medical advice, diagnosis, treatment, or clinical monitoring, and it is not a substitute for emergency response services.

KOTA relies on Bluetooth connectivity, device power, and internet or cellular networks. Ankota does not guarantee uninterrupted operation and is not responsible for failures caused by depleted batteries, loss of connectivity, environmental conditions, or third-party network outages outside its control.

In the event of a medical or personal emergency, users should contact local emergency services (911 in the U.S.).

KOTA’s Bluetooth-enabled button uses a long-life battery expected to last approximately one year under normal use.

Users, family members, or affiliated agencies are solely responsible for monitoring battery status and replacing batteries when required.

KOTA may provide low-battery or connectivity alerts; however, these alerts are supplementary tools and are not guaranteed. Ankota does not warrant battery life or device availability.

Many KOTA users participate through family caregivers, home-care agencies, or other authorized partners.

These partners may provide oversight functions such as reviewing alerts, checking device status, and coordinating follow-up actions. KOTA functions as a support tool within this broader care network and is not a standalone emergency response service.

Ankota is not responsible for failures, delays, or omissions by caregivers, agencies, or third-party partners.

KOTA is designed to meet the intent and functional characteristics of a Personal Emergency Response System (PERS) as defined by the U.S. Centers for Medicare & Medicaid Services (CMS) and applicable state Medicaid programs.

KOTA’s design may include features such as:

• Automated alerting with human escalation options
• Wearable or accessible activation devices within range of a paired hub
• Two-way voice or electronic communication capabilities
• Device supervision and maintenance processes intended to support continued operability

KOTA and its partners may support compliance with relevant HCBS, waiver, or PERS service standards through documentation, device testing, and secure data handling practices consistent with HIPAA and state privacy laws.

However, Ankota does not guarantee eligibility, approval, reimbursement, or continued funding under Medicaid, VA, or other government programs. Program compliance and billing obligations remain the responsibility of the applicable provider, agency, or Financial Management Services (FMS) entity.

KOTA’s effectiveness depends on proper setup, accurate contact information, device maintenance, and reliable network connectivity. Ankota disclaims liability for interruptions or failures caused by user neglect, depleted batteries, environmental interference, or network outages.

KOTA does not guarantee response times or emergency outcomes. Users and agencies are responsible for maintaining appropriate escalation protocols and contact lists.

Ankota designs KOTA using commercially reasonable hardware, software, and security practices. Services may be updated, modified, suspended, or discontinued at any time to improve functionality, security, or compliance, or for operational reasons.

Ankota does not guarantee that any feature will remain available indefinitely.

Ankota strives to maintain reliable and secure services while evolving the platform over time.

To the fullest extent permitted by law:

• Ankota, LLC and its affiliates shall not be liable for any indirect, incidental, consequential, special, or punitive damages, including personal injury or loss, arising from device malfunction, power loss, connectivity failures, or reliance on the Services.
• Your sole remedy for dissatisfaction with the Services is to discontinue use.
• Ankota’s total cumulative liability shall not exceed the greater of (a) the amount paid for the Services in the six months preceding the claim or (b) $100.

Some jurisdictions do not allow certain limitations; in such cases, liability will be limited to the maximum extent permitted by law.

KOTA collects limited personal and device data necessary to provide and improve the Services.

All personal information is handled in accordance with Ankota’s Privacy Policy, which is incorporated by reference and governs data use, storage, and disclosure. Where applicable, Ankota complies with HIPAA, HITECH, and relevant state privacy laws. In the event of a conflict, the Privacy Policy controls.

These Terms are governed by the laws of the Commonwealth of Massachusetts, without regard to conflict-of-law principles.

Any dispute arising out of or relating to these Terms or the Services shall be resolved through binding arbitration administered by the American Arbitration Association. You waive the right to participate in any class, collective, or representative action. Either party may pursue claims in small claims court where permitted.

• Eligibility & Authority: You represent that you are authorized to use KOTA on your own behalf or on behalf of the individual receiving services.
• Termination: Ankota may suspend or terminate access to the Services for misuse, violation of these Terms, or legal or security reasons.
• Severability: If any provision is found unenforceable, the remaining provisions will remain in effect.
• Force Majeure: Ankota is not liable for delays or failures caused by events beyond its reasonable control.

Ankota, LLC
1 Franklin Street, Unit 3608
Boston, MA 02110
Email: support@ankota.com