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Sign in to claim this brandSunrise Medical (US) LLC
United States·US-MF-000007254
Last updated September 17, 2026
About
Sunrise Medical designs and manufactures mobility products including lightweight wheelchairs, power wheelchairs, pediatric wheelchairs, wheelchair cushions and positioning supports.
From the manufacturer's own website. Source
What Sunrise Medical (US) LLC makes
Sunrise Medical (US) LLC makes a range of mobility products, including manual and electric wheelchairs, wheelchair cushions, and steering/control units. Their products include push-rim manual wheelchairs, gel-filled and foam-filled chair cushions, and electric-motor-driven wheelchairs. They also manufacture hands-free disability-assistive walkers and wheelchair recliners. Example devices include the Quickie 500H, Jay Encompass Back, and Zippie GS.
The company's portfolio is regulated under Class I and Class II devices and is listed in the eudamed, fda_510k, and fda_udi registries. Sunrise Medical (US) LLC is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does Sunrise Medical make?
Sunrise Medical makes mobility products, including manual and electric wheelchairs, wheelchair cushions, and steering/control units, because their product range includes these items as stated in the device categories.
Where is Sunrise Medical based?
Sunrise Medical is based in the US, as indicated by the country listed in the company information.
Which registries list Sunrise Medical's devices?
Sunrise Medical's devices are listed in the eudamed, fda_510k, and fda_udi registries, as these are the registries mentioned in the device data.
How are Sunrise Medical's devices classified?
Sunrise Medical's devices are classified as Class I and Class II devices, because these are the device classes specified in the device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 12002, Volunteer Blvd, Mount Juliet, United States
- Website
- www.sunrisemedical.com
- —
- facebook.com/sunrisemedical.us
- [email protected]
- Phone
- +18035717205
- PRRC Contact
- Neeraj Patel
- EUDAMED SRN
- US-MF-000007254
- FDA FEI Number
- 2937137
- DUNS Number
- —
Catalogue (117)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Switch-It CTRL+5 | CTRL+5 | EUDAMEDFDA UDI | Class I | Active |
| Switch-It Dual Pro | Dual Pro | EUDAMEDFDA UDI | Class I | Active |
| JAY Easy | Easy Back | EUDAMEDFDA UDI | Class I | Active |
| JAY J2 Plus Back | J2 Plus Back | EUDAMEDFDA UDI | Class I | Active |
| Whitmyer | Whitmyer | EUDAMEDFDA UDI | Class I | Active |
| J2 Plus | J2 Plus Cushion | EUDAMEDFDA UDI | Class I | Active |
| Zippie TS | Zippie TS Rigid | EUDAMEDFDA UDI | Class I | Active |
| Jay Fit 2u | FIT 2U Back | EUDAMEDFDA UDI | Class I | Active |
| Zippie TS SE | Zippie TS Folding | EUDAMEDFDA UDI | Class I | Active |
| Quickie Iris | Quickie Iris | EUDAMEDFDA UDI | Class I | Active |
| JAY Care | Care Cushion | EUDAMEDFDA UDI | Class I | Active |
| Jay Lite | Lite Cushion | EUDAMEDFDA UDI | Class I | Active |
| Jay Gs | GS Cushion | EUDAMEDFDA UDI | Class I | Active |
| Switch-It MicroPilot | MicroPilot | EUDAMEDFDA UDI | Class I | Active |
| Zippie Voyage | Voyage | EUDAMEDFDA UDI | Class I | Active |
| Jay J3 Carbon | J3 Carbon Back | EUDAMEDFDA UDI | Class I | Active |
| JAY Fit | Fit Back | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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FDA Recalls (11)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
The FDA recall records for Sunrise Medical (US) LLC show 11 recall records, with the earliest initiated on 2012-01-13 and the most recent on 2021-07-08. All recalls are recorded as terminated. The reasons given for the recalls include issues with product configuration, material deformation, component failure, and programming errors. The records list various specific problems, such as a wheelchair not being configured for motor vehicle use, a plastic latch deforming, and a backrest bracket failing. The reasons provided are based on the company's filings and are stated as given.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 8, 2021 | Z-2158-2021 | — | terminated | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| Jul 8, 2021 | Z-2157-2021 | — | terminated | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| Feb 13, 2020 | Z-1947-2020 | — | terminated | 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. |
| Jul 1, 2016 | Z-2290-2016 | — | terminated | 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. |
| Jul 27, 2015 | Z-2466-2015 | — | terminated | 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. |
| Jul 27, 2015 | Z-2467-2015 | — | terminated | 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. |
| Dec 19, 2014 | Z-1020-2015 | — | terminated | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| Dec 19, 2014 | Z-1019-2015 | — | terminated | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| Nov 11, 2013 | Z-0453-2014 | — | terminated | 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. |
| Jun 26, 2012 | Z-2113-2012 | — | terminated | 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. |
| Jan 13, 2012 | Z-1103-2012 | — | terminated | 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. |