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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

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)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Quickie 500H	500H	FDA UDI	Class II	Active
Jwx-2	XT	FDA UDI	Class II	Unknown
Quickie® Mid-Wheel Drive Power Wheelchair	EIPW11	FDA UDI	Class II	Unknown
Jay Encompass Back	Encompass	FDA UDI	Class I	Active
Quickie S-646	S-646	FDA UDI	Class II	Active
JayFit Back	Fit Back	FDA UDI	Class I	Unknown
Quickie Xenon	Xenon2, Xenon2 FF, Xenon2 Hybrid, Xenon2 SA	FDA UDI	Class I	Active
Zippie GS	GS, GS SE	FDA UDI	Class I	Active
Jay Fusion	Jay Flow Fluid/Jay Air/ Jay Fluid w/Cryo	FDA UDI	Class I	Active
Leckey Sleepform	Sleepform	FDA UDI	Class I	Unknown
Jay	Ion	FDA UDI	Class I	Active
Cool Cube / TouchDrive 2	CCB / TD2	FDA UDI	Class I	Active
Jay GO Cushion	Jay GO Cushion	FDA UDI	Class I	Active
Quickie Access	Access	FDA UDI	Class I	Active
Quickie Nitrum	Nitrum	FDA UDI	Class I	Active
CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick	Switch-It	FDA UDI	Class I	Active
Quickie QX/QXi	QX/QXi	FDA UDI	Class I	Active
Quickie® Rear Wheel Drive Power Wheelchair	EIS62	FDA UDI	Class II	Unknown
Frontier V4	Frontier V4 AWD or FWD	FDA UDI	Class II	Active
Leckey Shower Trolley	Shower Trolley	FDA UDI	Class I	Active
RGK Octane Sub4	Sub 4	FDA UDI	Class I	Active
Quickie 5R	5R	FDA UDI	Class I	Active
Zippie Kid Kart Xpress	Xpress	FDA UDI	Class I	Unknown
Quickie Q500/Q400 Series	Q500/Q400	FDA UDI	Class II	Active
Quickie Q500H Series Power Chair	5870	FDA UDI	Class II	Unknown
Empluse	F35	FDA UDI	Class II	Active
RGK Octane FX	FX	FDA UDI	Class I	Active
Jay	Duo	FDA UDI	Class I	Active
Rgk	Octane	FDA UDI	Class I	Active
Jay Basic Back	Basic Back	FDA UDI	Class I	Active
Switch-It Head Controls-External	Head Control	FDA UDI	Class I	Active
Quickie Q700M Series Power Chair	5856	FDA UDI	Class II	Unknown
Quickie® Rear Wheel Drive Power Wheelchair	EIPW2	FDA UDI	Class II	Unknown
Quickie 200R	200R	FDA UDI	Class II	Active
Quickie 5R	5R	FDA UDI	Class I	Unknown
Quickie Q500F Series Power Chair	5869	FDA UDI	Class II	Unknown
Quickie® Series Manual Wheelchair	ElZ4-2	FDA UDI	Class I	Unknown
Jay GO Back	Jay GO	FDA UDI	Class I	Active
Leckey MyWay Size 2	MyWay Size 2	FDA UDI	Class I	Active
Remote Stop Switch	SWI	FDA UDI	Class I	Active
Quickie 7 Series	7	FDA UDI	Class I	Active
Quickie P-222	P222	FDA UDI	Class II	Active
Zippie X'Cape	X'Cape	FDA UDI	Class I	Unknown
Quickie QRi	QRi	FDA UDI	Class I	Active
Quickie® Mid-Wheel Drive Power Wheelchair	EIPW22	FDA UDI	Class II	Unknown
Zippie® Series Manual Wheelchair	ElZ1A	FDA UDI	Class I	Unknown
Jay X2	X2	FDA UDI	Class I	Active
Quickie Q300M	Q300M	FDA UDI	Class II	Active
Zippie X'Cape	X'Cape	FDA UDI	Class I	Active
Zippie Kid Kart Xpress	Xpress	FDA 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.

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.