V-1504 VERTICAL PLATFORM LIFT

K960739 · Barnes,Richardson & Colburn · ING · Apr 1, 1996 · Physical Medicine

Device Facts

Record IDK960739
Device NameV-1504 VERTICAL PLATFORM LIFT
ApplicantBarnes,Richardson & Colburn
Product CodeING · Physical Medicine
Decision DateApr 1, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 890.3930
Device ClassClass 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

Related Devices

Submission Summary (Full Text)

{0} K960739 # 510(k) SUMMARY | Submitted by: | Barnes, Richardson & Colburn 1225 Eye Street, N.W. Washington, D.C. 20005 | APR - 1 1996 | | --- | --- | --- | | | Contact: Ansis M. Helmanis Tel: (202) 457-0300 | | | Date Prepared: | February 9, 1996 | | | Subject Device: | Savaria V-1504 Vertical Platform Lift | | | Predicate Device: | The National Wheel-O-Vator Co., Inc. Vertical Wheelchair Lift (K934553). See ATTACHMENT B for product literature. | | | Subject Product Description: | The V-1504 Vertical Platform Lift is a lift designed to carry a maximum of one wheelchair and two individuals (500 lb. capacity; 750 lb. optional) directly up and down between floors in a residential or public facility. It is designed for use both inside and outdoors and can be operated either enclosed or unenclosed. The V-1504 is driven by a 2:1 chain hydraulic system, consisting of two #50 high quality roller chains, a cylinder and pump powered by an electric (1.5 hp) motor. The breaking load and stress factor of each chain is 6200 lbs. The lift can be controlled from either end at a key-controlled station or from an on-board panel. All of the controls are of low voltage, incorporate continuous pressure directional buttons, and comply with U.S. ANSI/UL standard 508. The maximum lifting height is 23 feet, and the platform travels at a speed of 25 ft/min. The lift also provides for battery-powered lowering in emergency situations. The platform is constructed of ASTM A366 steel tubing and has an anti-skid surface. The enclosure is made of plexiglass and 0.100" steel tube. For more technical information see ATTACHMENT A, which also contains photographs and engineering drawings. | | 2 {1} Intended 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. Product Comparison: The V-1504 is substantially equivalent in design and function to National Wheel-O-Vator Co., Inc.'s Vertical Wheelchair Lifts (K934553). Also of steel construction, the Wheel-O-Vator lift uses principally the same design as the V-1504 and accommodates a 550 lb. load (750 lb. capacity optional). It provides a manual operation system similar to that of the V-1504. Moreover, it can be used both indoors and outdoors and can be custom-tailored for varying applications. A comparative table of features for the two devices is set forth on page 4. See ATTACHMENT B for full product labeling for the Wheel-O-Vator.
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