Sunrise Medical (US) LLC
Sunrise Medical (US) LLC appears in FDA public data with 10 recalls, 5 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2158-2021, Class II) was initiated on July 8, 2021. Its most recent 510(k) clearance was granted on March 30, 2022.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 5
- Inspections
- 7
- Compliance Actions
- 0
Known Names
sunrise medical (us), sunrise medical us
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2158-2021 | Class II | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for | July 8, 2021 |
| Z-2157-2021 | Class II | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for | July 8, 2021 |
| Z-1947-2020 | Class II | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is | February 13, 2020 |
| Z-2290-2016 | Class II | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's inten | July 1, 2016 |
| Z-2466-2015 | Class II | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system wi | July 27, 2015 |
| Z-2467-2015 | Class II | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system | July 27, 2015 |
| Z-1019-2015 | Class II | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | December 19, 2014 |
| Z-1020-2015 | Class II | Quickie Q7 Adult Rigid Wheelchair Model EIR4. | December 19, 2014 |
| Z-0453-2014 | Class II | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ1 | November 11, 2013 |
| Z-2113-2012 | Class II | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), | June 26, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K220213 | Empulse R90 | March 30, 2022 |
| K172384 | Quickie(r) Q700-UP M | January 16, 2018 |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) | July 14, 2016 |
| K142457 | Quickie, Zippie | December 18, 2014 |
| K133855 | BREEZY ELEGANCE | January 31, 2014 |