Bravoracer Pediatric Manual Wheelchair
FDA 510(k) K082314 · Otto Bock Healthcare LP
510(k) numberK082314
Submission
- Device name
- Bravoracer Pediatric Manual Wheelchair
- Applicant
- Otto Bock Healthcare LP
St Paul, MN, US - Received
- August 13, 2008
- Decision date
- October 28, 2008
- 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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| 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 |
|---|---|---|
| K213587 | MyCRO BandMVA · Traditional | 06/09/2022SE |
| K201426 | MyCRO BandMVA · Traditional | 03/26/2021SE |
| K113164 | Discovery Tmax Manual WheelchairIOR · Traditional | 03/11/2013SE |
| K111278 | Z10 Wheelchair Push and Brake Assist DeviceITI · Traditional | 09/16/2011SE |
| K111045 | Centro Family of Manual WheelchairsIOR · Traditional | 07/15/2011SE |
| K101524 | C2000 Powered WheelchairITI · Traditional | 09/29/2010SE |
| K073512 | Start JuniorIOR · Traditional | 01/14/2008SE |
| K070318 | Skippi Powered Wheelchair for ChildrenITI · Traditional | 05/11/2007SE |
| K052771 | Sensor WalkIQI · Traditional | 05/03/2006SE |
| K052706 | A-200 Powered WheelchairITI · Traditional | 12/27/2005SE |
Questions and answers
When was Bravoracer Pediatric Manual Wheelchair cleared by the FDA?
Bravoracer Pediatric Manual Wheelchair (K082314) received a 510(k) decision of Substantially Equivalent on October 28, 2008, 76 days after the submission was received.
What is the product code of K082314?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.