Explorer Powered Wheelchair
FDA 510(k) K023485 · Evermed Corp.
510(k) numberK023485
Submission
- Device name
- Explorer Powered Wheelchair
- Applicant
- Evermed Corp.
Phoenix, AZ, US - Received
- October 17, 2002
- Decision date
- December 2, 2002
- 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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Questions and answers
When was Explorer Powered Wheelchair cleared by the FDA?
Explorer Powered Wheelchair (K023485) received a 510(k) decision of Substantially Equivalent on December 2, 2002, 46 days after the submission was received.
What is the product code of K023485?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.