Monolift MPE2, Platform, Chair, Fully Futo Platfor
FDA 510(k) K850877 · Ketronic, Inc.
510(k) numberK850877
Submission
- Device name
- Monolift MPE2, Platform, Chair, Fully Futo Platfor
- Applicant
- Ketronic, Inc.
The Netherlands, NL - Received
- March 1, 1985
- Decision date
- June 12, 1985
- 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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More from Summit Harmar, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K850873 | Hilo Tables, Type CH-4, CH-8, FW-6, FW-5, FW-2, AlINO · Traditional | 06/12/1985SE |
| K850870 | Medifette Ergometer · Traditional | 06/12/1985SE |
| K850869 | Mfe Couch ErgometerISD · Traditional | 06/12/1985SE |
| K850868 | Mfe Cardiac Stress System · Traditional | 06/12/1985SE |
| K850872 | Phyaction 300, 360, 370, 390 & 391 Elec-Muscle-Sti · Traditional | 06/06/1985SN |
| K850871 | Tredband Type I, It, II & III - TreadmillsBXB · Traditional | 06/05/1985SE |
| K850876 | Ligtvoet L80.2 Lightfoot L80.2 Power WheelchairITI · Traditional | 05/16/1985SE |
| K850875 | Action-Wheels & Play Wheels · Traditional | 05/16/1985SE |
| K843288 | Ketronic Medax - NIYX · Traditional | 11/08/1984SE |
Questions and answers
When was Monolift MPE2, Platform, Chair, Fully Futo Platfor cleared by the FDA?
Monolift MPE2, Platform, Chair, Fully Futo Platfor (K850877) received a 510(k) decision of Substantially Equivalent on June 12, 1985, 103 days after the submission was received.
What is the product code of K850877?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.