Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,
FDA 510(k) K032402 · Convaid Products, Inc.
510(k) numberK032402
Submission
- Device name
- Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,
- Applicant
- Convaid Products, Inc.
Torrance, CA, US - Received
- August 4, 2003
- Decision date
- September 24, 2003
- 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.
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| 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 |
|---|---|---|
| K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T…IOR · Traditional | 10/18/2017SE |
| K140416 | Trekker, Trekker TransitIOR · Traditional | 09/17/2014SE |
| K120501 | Champ Champ TransitIOR · Traditional | 09/20/2012SE |
| K840250 | CarrierLBE · Traditional | 02/09/1984SE |
| K833195 | Umbrella WalkerITJ · Traditional | 10/27/1983SE |
| K822992 | People MoverINM · Traditional | 10/27/1982SE |
| K810676 | Convaid Cruiser CP4MLBE · Traditional | 03/26/1981SE |
| K781947 | Stroller, TherapyLBE · Traditional | 12/04/1978SE |
Questions and answers
When was Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T, cleared by the FDA?
Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T, (K032402) received a 510(k) decision of Substantially Equivalent on September 24, 2003, 51 days after the submission was received.
What is the product code of K032402?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.