Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sunrise Medical and its 1 subsidiaries with 48 510(k) clearances and 10 device recalls. The most recent is a 510(k) clearance dated Mar 30, 2022: Empulse R90.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sunrise Medical and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 30, 2022 | Empulse R90K220213 · ITI | 510(k) clearances |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person Class II · The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. | Device recalls |
| Jul 8, 2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person Class II · The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. | Device recalls |
| Feb 13, 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A ExClass II · Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond | Device recalls |
| Jan 16, 2018 | Quickie(r) Q700-UP MK172384 · IPL | 510(k) clearances |
| Jul 14, 2016 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)K160031 · ITI | 510(k) clearances |
| Jul 1, 2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to personClass II · There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occu | Device recalls |
| Jul 27, 2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobClass II · Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over ti | Device recalls |
| Jul 27, 2015 | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mClass II · Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over ti | Device recalls |
| Dec 19, 2014 | Quickie Q7 Adult Rigid Wheelchair Model EIR4.Class II · There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identi | Device recalls |
| Dec 19, 2014 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.Class II · There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identi | Device recalls |
| Dec 18, 2014 | Quickie, ZippieK142457 · ITI | 510(k) clearances |
| Jan 31, 2014 | BREEZY ELEGANCEK133855 · IOR | 510(k) clearances |
| Aug 16, 2013 | QUICKIE & ZIPPIE SERIESK123975 · IOR | 510(k) clearances |
| Jan 26, 2010 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIESK093070 · MNS | 510(k) clearances |
| Sep 28, 2009 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/STK091919 · BZD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
