Rascal We Go 250 Powered Wheelchair
FDA 510(k) K092130 · Electric Mobility, LLC
510(k) numberK092130
Submission
- Device name
- Rascal We Go 250 Powered Wheelchair
- Applicant
- Electric Mobility, LLC
Cherry Hill, NJ, US - Received
- July 15, 2009
- Decision date
- September 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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|---|---|---|
| K002616 | Electric Mobility Rascal and Chauffer ScootersINI · Special | 12/11/2000SE |
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| K924515 | Electric Mobility RascalINI · Traditional | 03/28/1994SN |
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| K874739 | Electric Mobility's SparkyITI · Traditional | 04/22/1988SE |
Questions and answers
When was Rascal We Go 250 Powered Wheelchair cleared by the FDA?
Rascal We Go 250 Powered Wheelchair (K092130) received a 510(k) decision of Substantially Equivalent on September 21, 2009, 68 days after the submission was received.
What is the product code of K092130?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.