Astrotilt Manual Wheelchair
FDA 510(k) K061475 · Pdg Product Design Group, Inc.
510(k) numberK061475
Submission
- Device name
- Astrotilt Manual Wheelchair
- Applicant
- Pdg Product Design Group, Inc.
Vancouver, Bc, CA - Received
- May 30, 2006
- Decision date
- June 14, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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.
Other 510(k)s with product code IOR
| 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 |
|---|---|---|
| K163432 | Stellar LEAPIOR · Traditional | 06/27/2017SE |
| K140023 | ElevationIOR · Traditional | 10/16/2014SE |
| K063736 | Fuze Mechanical Wheelchair, Models T20 and T50IOR · Traditional | 01/17/2007SE |
| K990557 | The Stellar Tilt, Manually Operated WheelchairIOR · Traditional | 03/22/1999SE |
| K971389 | Eclipse 400 Manually Operated WheelcairIOR · Traditional | 05/09/1997SE |
| K970311 | Bentley Manually Operated WheelchairIOR · Traditional | 02/14/1997SE |
| K961743 | Eclipse 600 Manually Operated WheelchairIOR · Traditional | 05/29/1996SE |
Questions and answers
When was Astrotilt Manual Wheelchair cleared by the FDA?
Astrotilt Manual Wheelchair (K061475) received a 510(k) decision of Substantially Equivalent on June 14, 2006, 15 days after the submission was received.
What is the product code of K061475?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.