A-200 Powered Wheelchair
FDA 510(k) K052706 · Otto Bock Healthcare LP
510(k) numberK052706
Submission
- Device name
- A-200 Powered Wheelchair
- Applicant
- Otto Bock Healthcare LP
Minneapolis, MN, US - Received
- September 28, 2005
- Decision date
- December 27, 2005
- 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 A-200 Powered Wheelchair cleared by the FDA?
A-200 Powered Wheelchair (K052706) received a 510(k) decision of Substantially Equivalent on December 27, 2005, 90 days after the submission was received.
What is the product code of K052706?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.