Action Wizard Pediatric Manual Wheelchair
FDA 510(k) K934646 · Invacare Corp.
510(k) numberK934646
Submission
- Device name
- Action Wizard Pediatric Manual Wheelchair
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- September 21, 1993
- Decision date
- December 15, 1993
- 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 |
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| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | 12/11/2018SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | 11/14/2018SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | 07/12/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | 04/17/2017SE |
| K162696 | Kuschall Advance Manual WheelchairIOR · Traditional | 12/28/2016SE |
Questions and answers
When was Action Wizard Pediatric Manual Wheelchair cleared by the FDA?
Action Wizard Pediatric Manual Wheelchair (K934646) received a 510(k) decision of Substantially Equivalent on December 15, 1993, 85 days after the submission was received.
What is the product code of K934646?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.