V-1504 VERTICAL PLATFORM LIFT
Device Facts
| Record ID | K960739 |
|---|---|
| Device Name | V-1504 VERTICAL PLATFORM LIFT |
| Applicant | Barnes,Richardson & Colburn |
| Product Code | ING · Physical Medicine |
| Decision Date | Apr 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3930 |
| Device Class | Class 2 |
Indications for Use
The V-1504 Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence or public facility.
Device Story
Vertical platform lift for wheelchair transport between floors; residential or public facility use. Input: user-initiated directional commands via key-controlled station or on-board panel. Operation: 2:1 chain hydraulic system; 1.5 hp electric motor; two #50 roller chains. Output: vertical movement of platform at 25 ft/min; max height 23 ft. Safety: continuous pressure buttons; battery-powered emergency lowering. Benefit: provides accessibility for wheelchair users.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Platform: ASTM A366 steel tubing with anti-skid surface. Enclosure: plexiglass and 0.100" steel tube. Drive: 2:1 chain hydraulic system; two #50 roller chains (6200 lbs breaking load); 1.5 hp electric motor. Controls: low voltage, continuous pressure, ANSI/UL 508 compliant.
Indications for Use
Indicated for individuals in wheelchairs requiring vertical transport between floors in residential or public facilities. No specific age or gender restrictions; maximum capacity 500 lbs (750 lbs optional).
Regulatory Classification
Identification
A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).
Special Controls
(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure; (ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety; (iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
Predicate Devices
- National Wheel-O-Vator Co., Inc. Vertical Wheelchair Lift (K934553)
Related Devices
- K960276 — WHEELCHAIR ELEVATOR · Services Industriels Savaria, Inc. · Apr 1, 1996
- K033469 — GENESIS VERTICAL PLATFORM LIFT · Garaventa Accessibility · Jan 7, 2004
- K983526 — VERTICAL LIFT · Barnes,Richardson & Colburn · Dec 11, 1998
- K113065 — RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS · Bella Elevator, LLC · Feb 22, 2012
- K020933 — GARAVENTA SUPER-TRAC TRE-52 · Garaventa Accessibility · Apr 4, 2002