Motion Concepts
FDA Regulatory Profile
Motion Concepts appears in FDA public data with 1 recall, 9 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2657-2014, Class II) was initiated on August 28, 2014. Its most recent 510(k) clearance was granted on August 13, 2019.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2657-2014 | Class II | TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. | August 28, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191376 | Modular Power Standing System | August 13, 2019 |
| K182995 | Bariatric Power Positioning System (BPPS) | March 8, 2019 |
| K150574 | Modular Power Positioning System | June 30, 2015 |
| K023426 | TRX VERTICAL POSITIONER | November 21, 2002 |
| K021264 | TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVA | July 30, 2002 |
| K994241 | TRX-CG POWER TILT AND RECLINE SYSTEM | January 13, 2000 |
| K990544 | TRX-CG POWER TILT AND RECLINE SYSTEM | April 8, 1999 |
| K981837 | TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS | July 9, 1998 |
| K970521 | TRX POWER TILT AND RECLINE SYSTEM | March 31, 1997 |