Hoveround Hoverglide Model Hoverglide MK-2
FDA 510(k) K093946 · Hoveround Corp.
510(k) numberK093946
Submission
- Device name
- Hoveround Hoverglide Model Hoverglide MK-2
- Applicant
- Hoveround Corp.
Sarasota, FL, US - Received
- December 23, 2009
- Decision date
- March 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K122741 | Hoveround TekniqueITI · Traditional | 05/07/2013SE |
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| K100527 | Hoveround Teknique, Model HD-6ITI · Special | 03/26/2010SE |
| K100350 | Hoveround Teknique GT Power Wheelchair, Model# Teknique GTITI · Traditional | 03/22/2010SE |
| K090108 | Hoveround Teknique FWD MK4 Power WheelchairITI · Traditional | 03/19/2009SE |
| K043069 | Hoveround E100 Power ChairITI · Traditional | 12/03/2004SE |
| K042920 | Hoveround SE-3 PowerchairITI · Traditional | 12/03/2004SE |
| K042545 | Hoveround MPV-5 PowerchairITI · Traditional | 10/21/2004SE |
| K042033 | Hoveround Power Wheelchair, Model HD700ITI · Traditional | 09/29/2004SE |
| K022993 | Hoveround Rehab Seating System for Power WheelchairsITI · Traditional | 12/02/2002SE |
Questions and answers
When was Hoveround Hoverglide Model Hoverglide MK-2 cleared by the FDA?
Hoveround Hoverglide Model Hoverglide MK-2 (K093946) received a 510(k) decision of Substantially Equivalent on March 22, 2010, 89 days after the submission was received.
What is the product code of K093946?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.