Data / Medical devices / United States / Sunrise Medical (us) LLC
Sunrise Medical (us) LLC: FDA-registered device maker in Fresno, CA, United States, 17 510(k) clearances
Sunrise Medical (us) LLC is registered with the FDA (registration 2937137) in Fresno, CA, United States. It lists 21 device types. The FDA files 17 510(k) clearances under its listings, the newest dated December 10, 2024. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2937137
- Address
- 3 E River Park Pl E, Fresno, CA, United States, 93720
- Owner or operator
- Sunrise Medical (US) LLC (9019832)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 7, 1992
- Registered through
- 2026
- Brand names listed
- Advance Bath Chair, BeMe Seating System, CTRL+5, Cool Cube, Dual Pro, Early Activity System, Empulse F35, Empulse M90 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Complaint file establishment | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Belt, Wheelchair | IQB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Board, Lap, Wheelchair | IMX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Brake, Extension, Wheelchair | IMW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Handrim, Wheelchair | IMO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Crutch And Cane, Wheelchair | IMZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Support, Head And Trunk, Wheelchair | IMS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wheelchair, Standup | IPL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2024 | K242327 | Empulse M90 | ITI | Substantially Equivalent | Concourse Assistive Technology Pty, Ltd. | accessdata.fda.gov |
| March 4, 2024 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| May 12, 2022 | K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | ITI | Substantially Equivalent | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | accessdata.fda.gov |
| March 30, 2022 | K220213 | Empulse R90 | ITI | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| November 19, 2021 | K213090 | Frontier Series Power Wheelchairs | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| July 9, 2021 | K211574 | Extreme X8 | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| March 17, 2021 | K203083 | Magic 360 Power Wheelchair | ITI | Substantially Equivalent | Magic Mobility | accessdata.fda.gov |
| September 10, 2020 | K200135 | RGK Daily Range Wheelchairs | IOR | Substantially Equivalent | Rgk Wheelchairs, Ltd. | accessdata.fda.gov |
| January 16, 2018 | K172384 | Quickie(r) Q700-UP M | IPL | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| December 18, 2014 | K142457 | Quickie, Zippie | ITI | Substantially Equivalent | Sunrise Medical (Us), LLC | accessdata.fda.gov |
| August 16, 2013 | K123975 | QUICKIE & ZIPPIE SERIES | IOR | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| April 10, 2009 | K090350 | EXTREME 4X4-X8 POWER WHEELCHAIR | ITI | Substantially Equivalent | Vestil Manufacturing Corp. | accessdata.fda.gov |
| September 10, 2007 | K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| December 15, 2000 | K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | ITI | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| October 25, 1998 | K983639 | ZIPPIE GS, MODEL # EIZGS | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| November 20, 1997 | K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
| July 6, 1995 | K952641 | QUICKIE TSR | IOR | Substantially Equivalent | Sunrise Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 8, 2021 | 88257 | Class II | Terminated | 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 transportation and seating for | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. | accessdata.fda.gov |
| February 13, 2020 | 85431 | Class II | Terminated | 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). | Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits. | accessdata.fda.gov |
| July 1, 2016 | 74596 | Class II | Terminated | 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. | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. | accessdata.fda.gov |
| July 27, 2015 | 71829 | Class II | Terminated | 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. | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. | accessdata.fda.gov |
| December 19, 2014 | 70141 | Class II | Terminated | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. | accessdata.fda.gov |
| November 11, 2013 | 66896 | Class II | Terminated | 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 person to move from one pla | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury. | accessdata.fda.gov |
| June 26, 2012 | 62493 | Class II | Terminated | 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 providing a means of mobil | Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm. | accessdata.fda.gov |
| January 13, 2012 | 61082 | Not yet classified | Terminated | Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility. | One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use. | accessdata.fda.gov |
| February 2, 2009 | 51260 | Not yet classified | Terminated | Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting posit | The stabilizer bar was inadvertently omitted during the manufacturing process. | accessdata.fda.gov |
| January 11, 2008 | 46908 | Not yet classified | Terminated | Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10 | Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself. | accessdata.fda.gov |
| April 23, 2007 | 38309 | Not yet classified | Terminated | Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays) | The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit. | accessdata.fda.gov |
| November 13, 2006 | 48662 | Not yet classified | Terminated | Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use. | Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash. | accessdata.fda.gov |
| November 15, 2005 | 34155 | Not yet classified | Terminated | Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727 | While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Mechanical
- All makers of Components, Wheelchair
- All makers of Walker, Mechanical
- All makers of Wheelchair, Powered
- All makers of Board, Lap, Wheelchair
- All makers of Adaptor, Hygiene
Updated December 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.