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Sunrise 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
LinkedIn: —
Facebook: facebook.com/sunrisemedical.us
Email: [email protected]
Phone: +18035717205
PRRC Contact: Neeraj Patel
EUDAMED SRN: US-MF-000007254
FDA FEI Number: 2937137
DUNS Number: —

Catalogue (117)

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Device	Model / Reference	Registries	Class	Status
Quickie Q700-UP M / Q700M	Q700-UP M / Q700M	FDA UDI	Class II	Active
Quickie Q400M/ Q500M Series Power Chair	5871	FDA UDI	Class II	Unknown
Jay Focus Point Back	Focus Point Back	FDA UDI	Class I	Active
Zippie Sphynx	Sphynx	FDA UDI	Class I	Active
Empluse	R20	FDA UDI	Class I	Active
Zippie GS	GS	FDA UDI	Class I	Unknown
Zippie Zone	Zone	FDA UDI	Class I	Active
Leckey MyWay Size 1	MyWay Size 1	FDA UDI	Class I	Active
Quickie Frontier V6	Frontier V6	FDA UDI	Class II	Active
Quickie	QS5 X	FDA UDI	Class I	Active
Jay Zip Cushion	Jay Zip Cushion	FDA UDI	Class I	Active
Switch-It	MicroGuide, MicroPilot, VersaGuide, VersaGuideEZ, Cool Cube	FDA UDI	Class I	Active
Quickie 2	Quickie 2, Quickie 2 Lite, Quickie 2 Lite 2.0	FDA UDI	Class I	Active
Quickie Xtender	Quickie Xtender	FDA UDI	Class II	Active
Quickie Q700H Series Power Chair	5891	FDA UDI	Class II	Unknown
Xtreme X8 4WD	Xtreme X8	FDA UDI	Class II	Active
Quickie GP	GP; GPV	FDA UDI	Class I	Active
Quickie Pulse	Pulse	FDA UDI	Class II	Active
Quickie Q700F Series Power Chair	5860	FDA UDI	Class II	Unknown
Jay Syncra Back	Syncra Back	FDA UDI	Class I	Active
Jay Union Cushion	Jay Union Cushion	FDA UDI	Class I	Active
Jay Syncra Cushion	Syncra Cushion	FDA UDI	Class I	Active
Leckey MyWay Size 3	MyWay Size 3	FDA UDI	Class I	Active
Zippie® Series Manual Wheelchair	ElZ5A	FDA UDI	Class I	Unknown
Sopur M6	M6	EUDAMEDFDA UDI	Class I	Active
Jay Zip	Zip Cushion	EUDAMEDFDA UDI	Class I	Active
Jay Xtreme Active	Xtreme Active Cushion	EUDAMEDFDA UDI	Class I	Active
JAY Balance	Balance Cushion	EUDAMEDFDA UDI	Class I	Active
Jay J2	J2 Cushion	EUDAMEDFDA UDI	Class I	Active
JAY Protector	Protector	EUDAMEDFDA UDI	Class I	Active
Quickie, Zippie	K142457	FDA 510(k)	Class II	Active
Breezy Elegance	K133855	FDA 510(k)	Class I	Active
Quickie(r) Q700-UP M	K172384	FDA 510(k)	Class II	Active
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)	K160031	FDA 510(k)	Class II	Active
Empulse R90	R90	EUDAMEDFDA UDI	Class I	Active
JAY Basic	Basic Cushion	EUDAMEDFDA UDI	Class I	Active
Sopur SR45	SR45	EUDAMEDFDA UDI	Class I	Active
Soft Combi P	Soft Combi P Cushion	EUDAMEDFDA UDI	Class I	Active
Jay J3	J3 Back	EUDAMEDFDA UDI	Class I	Active
Zippie Iris	Zippie Iris	EUDAMEDFDA UDI	Class I	Active
JAY Easy	Easy Fluid Cushion	EUDAMEDFDA UDI	Class I	Active
Switch-It MicroGuide	MicroGuide	EUDAMEDFDA UDI	Class I	Active
Jay Fit	Fit Cushion	EUDAMEDFDA UDI	Class I	Active
JAY Easy Visco	Easy Visco Cushion	EUDAMEDFDA UDI	Class I	Active
J3	J3 Cushion	EUDAMEDFDA UDI	Class I	Active
JAY LitePro Cushion	LitePro Cushion	EUDAMED	Class I	Active
Jay Zip	Zip Back	EUDAMEDFDA UDI	Class I	Active
JAY Care	Care Back	EUDAMEDFDA UDI	Class I	Active
JAY Adjustable Solid Seat	Adjustable Solid Seat	EUDAMEDFDA UDI	Class I	Active
Switch-It VersaGuide	VersaGuide	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Sunrise Medical GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.