Back Saver Lift Belt/Wheelchair Transfer Device
FDA 510(k) K864152 · Lossing Orthopedic, Inc.
510(k) numberK864152
Submission
- Device name
- Back Saver Lift Belt/Wheelchair Transfer Device
- Applicant
- Lossing Orthopedic, Inc.
Minneapolis, MN, US - Received
- October 23, 1986
- Decision date
- February 5, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILK – Transport, Patient, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5150
- Specialty
- Physical Medicine
A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
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| K222818 | Xpedition Powered Stair Chair (625700000000)ILK · Traditional | Stryker Medical | 01/24/2023SE |
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| K121560 | Levant, HomeglideILK · Traditional | Thyssenkrupp Accessibility B.V. | 11/01/2012SE |
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| K113308 | Bruno Elan Stairway ElevatorILK · Special | Bruno Independent Living Aids, Inc. | 02/01/2012SE |
| K111858 | Liftkar PTILK · Traditional | Sano Transportgeraete GmbH | 11/04/2011SE |
| K103122 | C-Max, C-Max U1, C-Max U1 160KG, C-Max U2, C-Max U2 160KG, S-Max, S-Max Aviation, S-Max…ILK · Traditional | Aat Alber Antriebstechnik GmbH | 12/30/2010SE |
| K093946 | Hoveround Hoverglide Model Hoverglide MK-2ILK · Traditional | Hoveround Corp. | 03/22/2010SE |
| K091858 | Pinnacle Stair Way LiftILK · Traditional | Summit Harmar, LLC | 07/01/2009SE |
More from Summit Harmar, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K900475 | Distrac(Tm) TableITH · Traditional | 05/24/1990SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | 08/07/1986SE |
| K843581 | Prom NaidITH · Traditional | 12/11/1984SE |
| K840551 | MobilizerION · Traditional | 03/23/1984SE |
| K823236 | Back on Track Inversion Therapy & ExerION · Traditional | 01/21/1983SE |
| K813017 | NecktracHST · Traditional | 11/25/1981SE |
| K802555 | Cottrell 90/90 BacktracHST · Traditional | 10/31/1980SE |
Questions and answers
When was Back Saver Lift Belt/Wheelchair Transfer Device cleared by the FDA?
Back Saver Lift Belt/Wheelchair Transfer Device (K864152) received a 510(k) decision of Substantially Equivalent on February 5, 1987, 105 days after the submission was received.
What is the product code of K864152?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.