Mechanical Wheelchair 890.3850
FDA 510(k) K945175 · Lumex, Inc.
510(k) numberK945175
Submission
- Device name
- Mechanical Wheelchair 890.3850
- Applicant
- Lumex, Inc.
Bay Shore, NY, US - Received
- October 21, 1994
- Decision date
- May 12, 1995
- 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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| K252370 | GEN 4 JOY WheelchairIOR · Traditional | Free Wheelchair Mission | 07/24/2026SE |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| 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 |
More from Zhenjiang Assure Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K963674 | Lumex AirFNM · Traditional | 01/10/1997SE |
| K962123 | Akrotech 4000T Kinetic Turning Low Air Loss SystemFNM · Traditional | 07/18/1996SE |
| K953675 | AltadyneFNM · Traditional | 09/28/1995SE |
| K945257 | 577ES (Ergosense)INO · Traditional | 04/26/1995SE |
| K944574 | Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-In-Space, 6000, MRI)IOR · Traditional | 10/17/1994SE |
| K923977 | Akrotech 4000IOQ · Traditional | 02/12/1993SE |
| K895740 | Shower Chairs;Bed/Stretcher;Linen & Utility CartFPO · Traditional | 02/22/1990SE |
Questions and answers
When was Mechanical Wheelchair 890.3850 cleared by the FDA?
Mechanical Wheelchair 890.3850 (K945175) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 203 days after the submission was received.
What is the product code of K945175?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.