Mechanical Wheelchair - L-Frame Series
FDA 510(k) K071444 · Colours 'N Motion
510(k) numberK071444
Submission
- Device name
- Mechanical Wheelchair - L-Frame Series
- Applicant
- Colours 'N Motion
Corona, CA, US - Received
- May 24, 2007
- Decision date
- July 27, 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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| 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 |
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| 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 |
More from Zhenjiang Assure Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K030017 | ChumpIOR · Traditional | 05/01/2003SE |
| K010823 | SpazzIOR · Traditional | 04/27/2001SE |
| K984354 | Mechanical WheelchairIOR · Traditional | 01/28/1999SE |
| K945153 | Mechanical Wheelchair- Lil DipperIOR · Traditional | 05/12/1995SE |
| K945151 | Mechanical Wheelchair- G-ForceIOR · Traditional | 05/12/1995SE |
| K945150 | Mechanical Wheerchair- EclipseIOR · Traditional | 05/12/1995SE |
| K945149 | Mechanical Wheelchair- ChallengerIOR · Traditional | 05/12/1995SE |
| K945148 | Mechanical Wheelchair- AvengerIOR · Traditional | 05/12/1995SE |
| K945152 | Mechanical Wheelchair- ImpactIOR · Traditional | 05/01/1995SE |
| K945534 | Mechanical Wheelchair - BoingIOR · Traditional | 01/02/1995SE |
Questions and answers
When was Mechanical Wheelchair - L-Frame Series cleared by the FDA?
Mechanical Wheelchair - L-Frame Series (K071444) received a 510(k) decision of Substantially Equivalent on July 27, 2007, 64 days after the submission was received.
What is the product code of K071444?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.