ING · Elevator, Wheelchair, Portable
Physical Medicine · 21 CFR 890.3930 · Class 2
Overview
| Product Code | ING |
|---|---|
| Device Name | Elevator, Wheelchair, Portable |
| Regulation | 21 CFR 890.3930 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption. Portable wheelchair elevators are Class II.
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.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113065 | RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS | Bella Elevator, LLC | Feb 22, 2012 | SESE |
| K110495 | LIFTKAR PT | Sano Transportgerate GmbH | May 20, 2011 | SESE |
| K102088 | JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT | Thyssenkrupp Ceteco Srl | Oct 20, 2010 | SESE |
| K091881 | RPL/CPL VERTICAL PLATFORM LIFTS | Harmar Summit, LLC | Jul 1, 2009 | SESE |
| K090856 | JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) | Thyssenkrupp Ceteco Srl | May 27, 2009 | SESE |
| K073513 | MERITS E700 PORCE LIFT | Merits Health Products Co., Ltd. | Jan 14, 2008 | SESE |
| K061514 | BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 | Bruno Independent Living Aids, Inc. | Jul 13, 2006 | SESE |
| K033469 | GENESIS VERTICAL PLATFORM LIFT | Garaventa Accessibility | Jan 7, 2004 | SESE |
| K024346 | THE MULTILIFT | Services Industriels Savaria, Inc. | Mar 4, 2003 | SESE |
| K020933 | GARAVENTA SUPER-TRAC TRE-52 | Garaventa Accessibility | Apr 4, 2002 | SESE |
| K983526 | VERTICAL LIFT | Barnes,Richardson & Colburn | Dec 11, 1998 | SESE |
| K981486 | STAIR-LIFT | Garaventa (Canada) , Ltd. | Jul 1, 1998 | SESE |
| K964134 | TRUS<T>LIFT PORCH LIFT | Trus T Lift | Dec 31, 1996 | SESE |
| K960739 | V-1504 VERTICAL PLATFORM LIFT | Barnes,Richardson & Colburn | Apr 1, 1996 | SESE |
| K960276 | WHEELCHAIR ELEVATOR | Services Industriels Savaria, Inc. | Apr 1, 1996 | SESE |
| K952946 | VANGATOR II | Crow River Industries, Inc. | Nov 29, 1995 | SESE |
| K941642 | ASCENDA | American Stair-Glide Corp. | Jun 13, 1994 | SESE |
| K934553 | WHEEL-O-VATOR | The National Wheel-O-Vator Co., Inc. | Feb 17, 1994 | SESE |
| K920105 | SCALAMOBIL | Alber Technologies, Inc. | Aug 6, 1992 | SESE |
| K922624 | ULTRAGATER WHEELCHAIR LIFT | Crow River Industries, Inc. | Jul 13, 1992 | SESE |
Top Applicants
- Crow River Industries, Inc. — 4 clearances
- The Cheney Co. — 3 clearances
- Barnes,Richardson & Colburn — 2 clearances
- Garaventa Accessibility — 2 clearances
- Metal Dynamics Corp. — 2 clearances
