Quickie & Zippie Series
FDA 510(k) K123975 · Sunrise Medical
510(k) numberK123975
Submission
- Device name
- Quickie & Zippie Series
- Applicant
- Sunrise Medical
Fresno, CA, US - Received
- December 26, 2012
- Decision date
- August 16, 2013
- 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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| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
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| K260849 | Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional | Rehasense USA, Inc. | 06/11/2026SE |
| K260642 | Manual Wheelchair (LW01108)IOR · Traditional | Anhui Longway Medical Technology Co., Ltd. | 06/02/2026SE |
| K260295 | Helio Kids; Apex PIOR · Traditional | Motion Composites | 05/28/2026SE |
| K254141 | Manual Wheelchair (DY01903(2))IOR · Traditional | Guangdong Dayang Medical Technology Co., Ltd. | 05/21/2026SE |
| K260121 | Manual Wheelchair (7101L, 7102LHD)IOR · Traditional | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 04/28/2026SE |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 03/31/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K093070 | Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesMNS · Traditional | 01/26/2010SE |
| K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/StBZD · Traditional | 09/28/2009SE |
| K082209 | Devilbiss DV5M Smartlink SystemBZD · Traditional | 10/28/2008SE |
| K081468 | Devilbiss Portable Oxygen Concentrator, 306 SeriesCAW · Traditional | 08/25/2008SE |
| K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesCAW · Special | 10/01/2007SE |
| K072153 | Quickie QX Manual Folding WheelchairIOR · Traditional | 09/10/2007SE |
| K071689 | Devilbiss Intellipap Model DV 5 SeriesBZD · Traditional | 09/07/2007SE |
| 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 |
| K053240 | Devilbiss Oxygen Cylinder Filling System, 535 SeriesCAW · Traditional | 02/03/2006SE |
Questions and answers
When was Quickie & Zippie Series cleared by the FDA?
Quickie & Zippie Series (K123975) received a 510(k) decision of Substantially Equivalent on August 16, 2013, 233 days after the submission was received.
What is the product code of K123975?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.