Galaxy Series Wheelchair
FDA 510(k) K023993 · Evermed Corp.
510(k) numberK023993
Submission
- Device name
- Galaxy Series Wheelchair
- Applicant
- Evermed Corp.
Anaheim, CA, US - Received
- December 3, 2002
- Decision date
- December 27, 2002
- 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 |
|---|---|---|
| K024030 | Millennium Series Manual WheelchairsIOR · Traditional | 12/12/2002SE |
| K023485 | Explorer Powered WheelchairITI · Traditional | 12/02/2002SE |
| K840846 | Sterile Hichman/Broviac Injection CapLJS · Traditional | 07/06/1984SE |
| K840529 | Steiger Tunneling Instrument 285DRC · Traditional | 03/12/1984SE |
| K830406 | Non-Sterile Catheter Repair KitsLJS · Traditional | 03/01/1983SE |
| K830256 | Non-Sterile Broviac Parenteral Alimi-LJS · Traditional | 03/01/1983SE |
| K830233 | Non-Sterile,Single/Souble Lumen-CathLJS · Traditional | 02/28/1983SE |
| K830257 | Non-Sterile Peritoneal Access Cathet-FKX · Traditional | 02/24/1983SE |
Questions and answers
When was Galaxy Series Wheelchair cleared by the FDA?
Galaxy Series Wheelchair (K023993) received a 510(k) decision of Substantially Equivalent on December 27, 2002, 24 days after the submission was received.
What is the product code of K023993?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.