Compliance & Documentation
A single source for all Luka Bear provider credentials, certifications, and regulatory documentation. Designed for facility procurement teams, grant reviewers, insurance reviewers, and Medicaid case managers.
Added Section 0 — “Intended Use & Functional Classification” — mapping Luka Bear’s functional support set to CMS Assistive Technology benefit criteria. All prior compliance content preserved.
NPI — Provider Registration
Eldercare Robotics LLC is registered with the Centers for Medicare & Medicaid Services (CMS) as a Type 2 Organization provider. This NPI is required for Medicaid enrollment, insurance reimbursement, and provider credentialing across all 50 states.
National Provider Identifier (NPI)
Compliance Portfolio v2.1
A complete, organized portfolio of every certification, declaration, and compliance document required for facility procurement, grant submissions, and reimbursement reviews.
Active Compliance Portfolio
The full portfolio is available for direct download below and via the Evidence Portal. It includes:
- Section 0 Intended Use & Functional Classification (new in v2.1)
- Appendix A Master Compliance Index
- Appendix B FDA Non-Medical Self-Declaration
- Appendix D FCC / CE / RoHS Certificate Bundle
- Appendix E Materials Safety File (EN 71-3, OEKO-TEX)
- Appendix F Internal Test & Verification Logs
Full Certifications List
Independent third-party certifications covering electromagnetic compatibility, electrical safety and materials safety — plus a plain summary of our privacy safeguards. All certificates are available for download in the Evidence Portal.
Electromagnetic Compatibility & Electrical Safety
- FCC Part 15 Subpart B Class B EMC compliance for unintentional radiators
- IEC 62368-1 Audio/video & IT equipment safety (Class III, low voltage)
- EN 55032 EMC for multimedia equipment — emissions
- EN 55024 EMC for multimedia equipment — immunity
- CE Marking Conformity with applicable EU directives
- RoHS Directive 2011/65/EU and 2015/863/EU restriction of hazardous substances
Materials Safety
- EN 71-3 Safety of toys — migration of certain elements (plush components)
- OEKO-TEX Standard 100 Tested for harmful substances in textiles
Privacy Safeguards
- Caregiver link Private, and protected by an access key
- Home network Luka never opens ports on your home network
- No 24/7 recording Short activity clips are made only when Away Monitoring is on
- Clip retention Clips are stored in the cloud and deleted automatically after 7 days, or sooner by hand
- Camera view log Every time the camera view is opened is logged
- Facility Admin PIN Optional — locks setup and care settings
eMMA Government Registration
Eldercare Robotics LLC is registered on eMaryland Marketplace Advantage (eMMA) — the official Maryland state procurement platform.
eMaryland Marketplace Advantage
eMMA registration enables Eldercare Robotics LLC to participate in Maryland state procurement opportunities, including contracts issued by state agencies, county governments, and state-funded programs. This is a foundational requirement for accessing public-sector eldercare technology programs in Maryland.
- Registration Status Active
- Effective Date March 28, 2026
- Eligible For Maryland state agency contracts
- Eligible For County and municipal procurement
- Eligible For State-funded eldercare programs
- Vendor Type Technology / Assistive Device
Privacy & Data Security
Luka is built privacy-first. Here are the safeguards every Luka has today, in plain terms.
How Luka Protects Your Family’s Information
Luka Bear is a non-medical companion. The camera, the voices, and everything about your loved one stay within the circle of people you choose.
- Caregiver access A private link protected by an access key
- Home network Luka never opens ports on your home network
- Recording No 24/7 recording
- Activity clips Only when Away Monitoring is on; deleted automatically after 7 days
- Camera view log A log shows every time the camera view is opened
- Your data Never sold or shared with advertisers — export or deletion on request
FDA Classification
Luka Bear is formally classified as a non-medical assistive companion device. It does not diagnose, treat, cure, or prevent any disease.
Non-Medical Assistive Companion Device
Luka Bear is classified under the FDA General Wellness Policy (July 2016) and the Assistive Technology Act of 2004 (29 U.S.C. § 3002). A formal written self-declaration is on file.
- Policy Anchor FDA General Wellness Policy (July 2016)
- Statutory Anchor Assistive Technology Act of 2004 (29 U.S.C. § 3002)
- Self-Declaration Signed and on file (Appendix B of Portfolio)
- Intended Use General wellness, companionship, caregiver support
- NOT Intended To Diagnose, treat, cure, mitigate, or prevent disease
- NOT An emergency response system or 911 substitute
Medicaid Enrollment Status
Eldercare Robotics LLC is actively pursuing and completing Medicaid provider enrollment across multiple states to support reimbursement pathways for assistive eldercare technology.
Multi-State Enrollment In Progress
Medicaid enrollment varies by state and program type. Eldercare Robotics LLC is in active enrollment with the following programs:
- Pennsylvania PROMISe Application submitted May 16, 2026 (ATN 1101562683) — awaiting OMAP determination letter
- Maryland ePREP Enrollment in progress — typical 60–90 day determination
- Virginia Medicaid (DMAS) Provider ID 30018605100001, enrolled effective 5/11/2026. Atypical Provider Identifier (Base ID) 3001860510. Specialty 462 Assistive Technology (taxonomy 225CA2500X) and Specialty 662 Electronic Home Based Supports (taxonomy 333300000X) submitted 5/27/2026 — pending DMAS Provider Clerk approval.
- DC Services My Way enrollment pathway under review
- NY CDPAP / TBI / NHTD vendor pathways under review
- National NPI Type 2 active for all federal Medicaid systems
Full Document Library
All compliance documentation, certificates, declarations, and pilot data are organized in the Luka Evidence Portal — available 24/7 for facility procurement teams, grant reviewers, and authorized referral partners.
📂 Luka Evidence Portal
Centralized, structured access to every document a facility, grant reviewer, or reimbursement gatekeeper might request. Public documents do not require login.
Access All Compliance Documents →- Compliance Portfolio v2.1 (DOCX)
- NPI Confirmation Letter (PDF)
- W-9 — Eldercare Robotics LLC
- FDA Non-Medical Self-Declaration
- FCC / CE / RoHS Certificates
- EN 71-3 / OEKO-TEX Materials Safety
- Luka Bear Complete Manual (PDF)
- Reimbursement Pathways Overview
Have a compliance question?
Facility procurement teams, grant reviewers, insurance reviewers, and case managers: contact us directly for watermarked copies of any compliance document, privacy questions, or current enrollment status in your state.
Compliance questions: info@eldercarerobotics.net · (413) 296-LUKA
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