Manual Wheelchair (W47)
FDA 510(k) K252828 · Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
510(k) numberK252828
Submission
- Device name
- Manual Wheelchair (W47)
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
Danyang, CN - Received
- September 5, 2025
- Decision date
- December 5, 2025
- 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 |
|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01)JCX · Traditional | 05/11/2026SE |
| K253632 | Manual Wheelchair (W50)IOR · Traditional | 01/29/2026SE |
| K252825 | Manual Wheelchair (W45)IOR · Traditional | 12/05/2025SE |
| K251130 | Portable Oxygen Concentrator (JM-P50A)CAW · Traditional | 08/21/2025SE |
| K232783 | Power wheelchair (Model: JMPW-01W)ITI · Traditional | 01/19/2024SE |
| K230969 | Oxygen ConcentratorCAW · Traditional | 11/09/2023SE |
| K200466 | Manual Wheelchair (Model W28)IOR · Traditional | 06/14/2021SE |
Questions and answers
When was Manual Wheelchair (W47) cleared by the FDA?
Manual Wheelchair (W47) (K252828) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 91 days after the submission was received.
What is the product code of K252828?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.