Kuschall Advance Manual Wheelchair
FDA 510(k) K162696 · Invacare Corporation
510(k) numberK162696
Submission
- Device name
- Kuschall Advance Manual Wheelchair
- Applicant
- Invacare Corporation
Elyria, OH, US - Received
- September 27, 2016
- Decision date
- December 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
Other 510(k)s with product code IOR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7)IOR · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 08/06/2026SE |
| 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 |
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| K203210 | Invacare Platinum 5NXG Oxygen ConcentratorCAW · Traditional | 04/12/2021SE |
| K202379 | Invacare AVIVA Storm RX Power ChairITI · Traditional | 03/19/2021SE |
| K200890 | Invacare Perfecto2V Oxygen ConcentratorCAW · Traditional | 08/06/2020SE |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI · Traditional | 01/02/2020SE |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…CAW · Traditional | 08/29/2019SE |
| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | 12/11/2018SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | 11/14/2018SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | 07/12/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | 04/17/2017SE |
| K162692 | Kuschall K-Series Attract Manual WheelchairIOR · Traditional | 12/28/2016SE |
Questions and answers
When was Kuschall Advance Manual Wheelchair cleared by the FDA?
Kuschall Advance Manual Wheelchair (K162696) received a 510(k) decision of Substantially Equivalent on December 28, 2016, 92 days after the submission was received.
What is the product code of K162696?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.