WHEELCHAIR ELEVATOR
Device Facts
| Record ID | K960276 |
|---|---|
| Device Name | WHEELCHAIR ELEVATOR |
| Applicant | Services Industriels Savaria, Inc. |
| 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 ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility.
Device Story
Unenclosed stair platform lift; transports wheelchair and occupant between floors. Input: user-initiated commands via key-controlled station or on-board hand-held panel. Operation: cable/drum drive unit (3/16" aircraft cable, 4,200 lbs breaking load) moves carriage along stairs. Output: vertical displacement of wheelchair. Used in private residences or public facilities; operated by user or caregiver. Safety features: mechanical emergency brake, obstruction sensors, upper/lower limit switches. Benefits: provides accessibility for wheelchair users in multi-level environments.
Clinical Evidence
No clinical data. Bench testing only; compliance with ANSI-A17.1 Code specifications for elevating devices for the handicapped.
Technological Characteristics
Materials: ASTM 30 tubular steel. Drive: cable/drum unit (3/16" aircraft cable). Power: 110 VAC, 1Ph, 60 Hz, 15 amp. Speed: 14 ft/min. Load capacity: 450 lbs. Incline: up to 45 degrees. Features: non-skid fold-away platform, automatic dual access ramps, mechanical emergency brake, obstruction sensors, limit switches.
Indications for Use
Indicated for individuals in wheelchairs requiring mechanical transport between floors in residential or public facilities via stairways with inclines up to 45 degrees; maximum load 450 lbs.
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
- Cheney Liberty Wheelchair Lift (K893544)
Related Devices
- K960739 — V-1504 VERTICAL PLATFORM LIFT · Barnes,Richardson & Colburn · Apr 1, 1996
- K020933 — GARAVENTA SUPER-TRAC TRE-52 · Garaventa Accessibility · Apr 4, 2002
- K981486 — STAIR-LIFT · Garaventa (Canada) , Ltd. · Jul 1, 1998
- K983526 — VERTICAL LIFT · Barnes,Richardson & Colburn · Dec 11, 1998
- K102088 — JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT · Thyssenkrupp Ceteco Srl · Oct 20, 2010
