Champ Champ Transit
FDA 510(k) K120501 · Convaid Products, Inc.
510(k) numberK120501
Submission
- Device name
- Champ Champ Transit
- Applicant
- Convaid Products, Inc.
Torrance, CA, US - Received
- February 21, 2012
- Decision date
- September 20, 2012
- 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 |
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| 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 |
| K032402 | Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,IOR · Traditional | 09/24/2003SE |
| 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 Champ Champ Transit cleared by the FDA?
Champ Champ Transit (K120501) received a 510(k) decision of Substantially Equivalent on September 20, 2012, 212 days after the submission was received.
What is the product code of K120501?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.