Modular Power Standing System
FDA 510(k) K191376 · Motion Concepts
510(k) numberK191376
Submission
- Device name
- Modular Power Standing System
- Applicant
- Motion Concepts
Concord, CA - Received
- May 23, 2019
- Decision date
- August 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPL – Wheelchair, Standup
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3900
- Specialty
- Physical Medicine
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More from Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
| 510(k) | Device | Decision |
|---|---|---|
| K182995 | Bariatric Power Positioning System (BPPS)ITI · Traditional | 03/08/2019SE |
| K150574 | Modular Power Positioning SystemITI · Traditional | 06/30/2015SE |
| K023426 | TRX Vertical PositionerITI · Traditional | 11/21/2002SE |
| 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 Modular Power Standing System cleared by the FDA?
Modular Power Standing System (K191376) received a 510(k) decision of Substantially Equivalent on August 13, 2019, 82 days after the submission was received.
What is the product code of K191376?
The FDA product code is IPL – Wheelchair, Standup, a Class II (moderate risk) device regulated under 21 CFR 890.3900.