Navajo Model 103A Wheelchair
FDA 510(k) K870293 · Redman, Inc.
510(k) numberK870293
Submission
- Device name
- Navajo Model 103A Wheelchair
- Applicant
- Redman, Inc.
Bloomington, MN, US - Received
- January 28, 1987
- Decision date
- February 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
|---|---|---|
| K940920 | Road SavageITI · Traditional | 02/03/1995SN |
| K940919 | Chief SRIPL · Traditional | 02/03/1995SN |
| K940852 | Chief Standup WheelchairIPL · Traditional | 02/03/1995SN |
| K940851 | Red Pack Manlual Power Wheelchair Conversion KitITI · Traditional | 02/03/1995SN |
| K935751 | Geronimo PRITI · Traditional | 02/03/1995SN |
| K935750 | GeronimoITI · Traditional | 02/03/1995SN |
| K935749 | Road WarriorITI · Traditional | 01/13/1995SN |
| K870298 | Redman AccessoriesKNO · Traditional | 02/26/1987SE |
| K870299 | Redman Upholstery Series for WheelchairsKNN · Traditional | 02/10/1987SE |
| K870297 | Dakota Model 102C WheelchairITI · Traditional | 02/10/1987SE |
Questions and answers
When was Navajo Model 103A Wheelchair cleared by the FDA?
Navajo Model 103A Wheelchair (K870293) received a 510(k) decision of Substantially Equivalent on February 10, 1987, 13 days after the submission was received.
What is the product code of K870293?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.