VivaLift!® Urbana - PLR-965 Testing Standards & Warranty
FDA Class II Medical Device*
Meeting and Exceeding High Standards for your Peace of Mind.
Your Pride product has undergone thorough product testing to ensure safety, durability and performance.
Our power chairs, scooters and lift chairs are FDA medical devices that require specific testing prior to release for public use.
The testing requirements accepted by the FDA were developed by the American National Standards Institute/Rehabilitation Engineering & Assistive Technology Society of North America (ANSI/RESNA).
The tests are conducted in accordance with the requirements of the ANSI/RESNA Test Standards and complement an additional stringent testing regimen developed by Pride's Research & Development Team.
All products have passed, and in many cases, exceeded test criteria set forth, assuring the high level of quality synonymous with Pride.
In addition to “real world” testing developed by Pride during more than thirty years of designing Lift Chairs, our products are subjected to a host of standardized testing criteria, including but not limited to:
ANSI/AAMI/ES60601-1, Medical Electrical Equipment--Part 1: General Requirements for Basic Safety and Essential Performance, and ANSI/AAMI/IEC 60601-1-2, Medical Electrical Equipment--Part 1-2: General Requirements for Basic Safety and Essential Performance--Collateral Standard: Electromagnetic Disturbances--Requirements and Tests
ANSI/AAMI/ISO 10993-5, Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro Cytotoxicity, and ANSI/AAMI/ISO 10993-10, Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Skin Sensitization
IEC 62304, Medical Device Software--Software Life Cycle Processes
IEC 60335-1:2012, Safety of Household Electrical Appliances
ISO 14971 Medical devices – Application of risk management to medical devices
EN 12182, Assistive products for persons with disability. General requirements and test methods
Static Load and Stability Tests
Strength & Fatigue Verification Tests
Overall Product Performance Verification
Dimensional Requirement Compliance
Armrest Force Test
Material Protective Coating Testing Verification
Misuse and Abuse Testing
Environmental Testing for Adverse Conditions
Electronic Systems Performance and Durability
Chemical and Bio-Contamination Analysis Testing for Toxicity Verification
Cal 117 Flammability Test Compliance for Seating Foam and Fabric Components
UL94VO Flammability Testing for Compliance of Plastic Components