Company ยท US
Sunrise Medical (US) LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2022. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2022 | K220213 | Empulse R90 Sunrise Medical (Us), LLC | ITI |
| Jan 16, 2018 | K172384 | Quickie(r) Q700-UP M Sunrise Medical (Us), LLC | IPL |
| Jul 14, 2016 | K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) Sunrise Medical (Us), LLC | ITI |
| Dec 18, 2014 | K142457 | Quickie, Zippie Sunrise Medical (Us), LLC | ITI |
| Jan 31, 2014 | K133855 | BREEZY ELEGANCE Sunrise Medical (Us), LLC | IOR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2021 | Sunrise Medical (US) LLC Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportat Terminated |
INM | None listed |
| Jul 8, 2021 | Sunrise Medical (US) LLC Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportat Terminated |
INM | None listed |
| May 11, 2020 | Sunrise Medical (US) LLC Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Terminated |
ITI | K142457 |
| Jul 25, 2016 | Sunrise Medical (US) LLC Quickie Q7 wheelchair. Model EIR4
Physical Medicine.
The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. Terminated |
IOR | K123975 |
| Aug 26, 2015 | Sunrise Medical (US) LLC Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option.
Provide mobility to persons limited to a sitting position. Terminated |
IOR | K123975 |
| Aug 26, 2015 | Sunrise Medical (US) LLC Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option.
Provide mobility to persons limited to a sitting position. Terminated |
IOR | K123975 |
| Jan 27, 2015 | Sunrise Medical (US) LLC Quickie Q7 Adult Rigid Wheelchair Model EIR4. Terminated |
IOR | K123975 |
| Jan 27, 2015 | Sunrise Medical (US) LLC Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. Terminated |
IOR | K973673 |
| Dec 5, 2013 | Sunrise Medical (US) LLC Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA.
Used by a pers Terminated |
IOR | K123975 |
| Jul 31, 2012 | Sunrise Medical (US) LLC Padded Swing Away Arm Rest with Receiver;
Uses on wheelchair models:
Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1).
Product Usage:
To empower physically challenged persons by provi Terminated |
IOR | K973673 |
| Feb 24, 2012 | Sunrise Medical (US) LLC Sunrise Medical Zippie TS wheelchair
To empower physically challenged person by providing a means or mobility. Terminated |
IOR | K973673 |