Hoveround Hoverglide Model Hoverglide MK-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093946 FDA 510(k)
- FDA Product Code
- ILK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5150 FDA 510(k)
- Regulation Number
- 890.5150 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a powered patient transport device, as defined in the device name and openfda fields. It is substantially equivalent to a predicate device and cleared under the traditional 510(k) pathway.
It is manufactured by Hoveround Corp. and authorized under FDA 510(k) clearance K093946. The device is classified as a Class II medical device with product code ILK and regulation number 890.5150, and is intended for use in physical medicine settings.
Frequently asked questions
What is the Hoveround Hoverglide MK-2 used for?
The Hoveround Hoverglide MK-2 is a powered patient transport device intended for use in physical medicine settings, as defined by its device name and classification under product code ILK and regulation number 890.5150.
How is the Hoveround Hoverglide MK-2 supplied or powered?
The device is a powered patient transport device, meaning it operates using an internal power source to assist in moving patients, though specific power source details are not provided in the device data.
Is the Hoveround Hoverglide MK-2 a single-use or reusable device?
The device data does not specify whether the Hoveround Hoverglide MK-2 is single-use or reusable; however, as a powered patient transport device, it is designed for repeated use in clinical environments.
What regulatory pathway was used for the Hoveround Hoverglide MK-2?
The Hoveround Hoverglide MK-2 was cleared under the traditional 510(k) pathway, as indicated by its authorization under FDA 510(k) K093946 and classification as substantially equivalent to a predicate device.
What are the key identifiers for the Hoveround Hoverglide MK-2?
The device is identified by its name HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2, manufacturer Hoveround Corp., FDA 510(k) number K093946, product code ILK, and regulation number 890.5150.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093946 | Class II | Active |
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Manufacturer
- Manufacturer
- Hoveround Corp.
Sources (1)
- FDA 510(k) K093946 24 fields · synced Sep 23, 2026