Hoveround E100 Power Chair
FDA 510(k) K043069 · Hoveround Corp.
510(k) numberK043069
Submission
- Device name
- Hoveround E100 Power Chair
- Applicant
- Hoveround Corp.
Sarasota, FL, US - Received
- November 8, 2004
- Decision date
- December 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K042545 | Hoveround MPV-5 PowerchairITI · Traditional | 10/21/2004SE |
| K042033 | Hoveround Power Wheelchair, Model HD700ITI · Traditional | 09/29/2004SE |
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Questions and answers
When was Hoveround E100 Power Chair cleared by the FDA?
Hoveround E100 Power Chair (K043069) received a 510(k) decision of Substantially Equivalent on December 3, 2004, 25 days after the submission was received.
What is the product code of K043069?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.