TRX Vertical Positioner
FDA 510(k) K023426 · Motion Concepts
510(k) numberK023426
Submission
- Device name
- TRX Vertical Positioner
- Applicant
- Motion Concepts
Concord, Ontario, CA - Received
- October 11, 2002
- Decision date
- November 21, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type…
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More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191376 | Modular Power Standing SystemIPL · Traditional | 08/13/2019SE |
| K182995 | Bariatric Power Positioning System (BPPS)ITI · Traditional | 03/08/2019SE |
| K150574 | Modular Power Positioning SystemITI · Traditional | 06/30/2015SE |
| K021264 | Trz-Cg Power Positioning System with Center-Of-Gravity Shifting Power Tilt, Recline, and…ITI · Traditional | 07/30/2002SE |
| K994241 | Trx-Cg Power Tilt and Recline SystemITI · Traditional | 01/13/2000SE |
| K990544 | Trx-Cg Power Tilt and Recline SystemITI · Traditional | 04/08/1999SE |
| K981837 | Trx-Cg Center-Of-Gravity Shifting Power Tilt and Recline SystemsITI · Traditional | 07/09/1998SE |
| K970521 | TRX Power Tilt and Recline SystemITI · Traditional | 03/31/1997SE |
Questions and answers
When was TRX Vertical Positioner cleared by the FDA?
TRX Vertical Positioner (K023426) received a 510(k) decision of Substantially Equivalent on November 21, 2002, 41 days after the submission was received.
What is the product code of K023426?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.