Quickie QX Manual Folding Wheelchair
FDA 510(k) K072153 · Sunrise Medical, Inc.
510(k) numberK072153
Submission
- Device name
- Quickie QX Manual Folding Wheelchair
- Applicant
- Sunrise Medical, Inc.
Fresno, CA, US - Received
- August 3, 2007
- Decision date
- September 10, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IOR – Wheelchair, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3850
- Specialty
- Physical Medicine
A mechanical wheelchair is a manually 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/or require an assistive device for mobility.
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| K123975 | Quickie & Zippie SeriesIOR · Traditional | 08/16/2013SE |
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| K062701 | Quickie Rhapsody, MWD Series II Power WheelchairITI · Special | 09/25/2006SE |
| K060531 | Quickie Rhythm & Groove Series Power Wheelchairs W/Quickie Delphi ControlsITI · Special | 03/17/2006SE |
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Questions and answers
When was Quickie QX Manual Folding Wheelchair cleared by the FDA?
Quickie QX Manual Folding Wheelchair (K072153) received a 510(k) decision of Substantially Equivalent on September 10, 2007, 38 days after the submission was received.
What is the product code of K072153?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.