Extreme 4X4-X8 Power Wheelchair
FDA 510(k) K090350 · Vestil Manufacturing Corp.
510(k) numberK090350
Submission
- Device name
- Extreme 4X4-X8 Power Wheelchair
- Applicant
- Vestil Manufacturing Corp.
Angola, IN, US - Received
- February 11, 2009
- Decision date
- April 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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|---|---|---|
| K030783 | Frontier Model X5ITI · Traditional | 04/04/2003SE |
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| K014127 | Karma Discovery, Model KP40ITI · Traditional | 03/15/2002SE |
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Questions and answers
When was Extreme 4X4-X8 Power Wheelchair cleared by the FDA?
Extreme 4X4-X8 Power Wheelchair (K090350) received a 510(k) decision of Substantially Equivalent on April 10, 2009, 58 days after the submission was received.
What is the product code of K090350?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.