Empulse R90
Sunrise Medical (US) LLC
SUNRISE MEDICAL (US) LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2937137 | 2937137 | SUNRISE MEDICAL (US) LLC | 1 | N | 2026-01-01 | 3 E River Park Pl E FRESNO CA US 93720 |
| 3019677893 | 3019677893 | Sunrise Medical (US) LLC | 1 | Y | 2026-01-01 | 12002 Volunteer Blvd Mount Juliet TN US 37122 |
| 1720745 | 1720745 | SUNRISE MEDICAL (US) LLC | 1 | N | 2020-04-25 | 6899 Winchester Cir Ste 200 Boulder CO US 80301 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296575 | 1913253426 | K983639 | ZIPPIE GS, MODEL # EIZGS | IOR | 1998-10-25 |
| 15783 | 1913253426 | K983639 | ZIPPIE GS, MODEL # EIZGS | IOR | 1998-10-25 |
| 15783 | 1290450657 | K983520 | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD | ITI | 1998-11-06 |
| 15783 | 1543905458 | K982989 | QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR | IOR | 1998-10-05 |
| 15783 | 1380684028 | K981462 | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 | ITI | 1998-11-06 |
| 15783 | 1742548509 | K974820 | BREEZY SERIES | IOR | 1998-01-27 |
| 15783 | 2063379258 | K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES | IOR | 1997-11-20 |
| 296575 | 2063379258 | K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES | IOR | 1997-11-20 |
| 15783 | 1927402302 | K952641 | QUICKIE TSR | IOR | 1995-07-06 |
| 296575 | 1927402302 | K952641 | QUICKIE TSR | IOR | 1995-07-06 |
| 15783 | 1037498612 | K242327 | Empulse M90 | ITI | 2024-12-10 |
| 296575 | 1037498612 | K242327 | Empulse M90 | ITI | 2024-12-10 |
| 15783 | 1063245786 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | ITI | 2024-03-04 |
| 296575 | 1063245786 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | ITI | 2024-03-04 |
| 15783 | 2033338499 | K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | ITI | 2022-05-12 |
| 296575 | 2033338499 | K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | ITI | 2022-05-12 |
| 296575 | 1411187402 | K220213 | Empulse R90 | ITI | 2022-03-30 |
| 15783 | 1411187402 | K220213 | Empulse R90 | ITI | 2022-03-30 |
| 296575 | 1370092761 | K213090 | Frontier Series Power Wheelchairs | ITI | 2021-11-19 |
| 15783 | 1370092761 | K213090 | Frontier Series Power Wheelchairs | ITI | 2021-11-19 |
| 296575 | 1416539063 | K211574 | Extreme X8 | ITI | 2021-07-09 |
| 15783 | 1416539063 | K211574 | Extreme X8 | ITI | 2021-07-09 |
| 15783 | 1486116288 | K203083 | Magic 360 Power Wheelchair | ITI | 2021-03-17 |
| 296575 | 1486116288 | K203083 | Magic 360 Power Wheelchair | ITI | 2021-03-17 |
| 15783 | 1718538539 | K200135 | RGK Daily Range Wheelchairs | IOR | 2020-09-10 |
| 15783 | 1805935546 | K172384 | Quickie(r) Q700-UP M | IPL | 2018-01-16 |
| 296575 | 1805935546 | K172384 | Quickie(r) Q700-UP M | IPL | 2018-01-16 |
| 15783 | 1625454464 | K142457 | Quickie, Zippie | ITI | 2014-12-18 |
| 296575 | 1625454464 | K142457 | Quickie, Zippie | ITI | 2014-12-18 |
| 15783 | 1612003167 | K123975 | QUICKIE & ZIPPIE SERIES | IOR | 2013-08-16 |
| 296575 | 1612003167 | K123975 | QUICKIE & ZIPPIE SERIES | IOR | 2013-08-16 |
| 296575 | 1191116611 | K090350 | EXTREME 4X4-X8 POWER WHEELCHAIR | ITI | 2009-04-10 |
| 15783 | 1191116611 | K090350 | EXTREME 4X4-X8 POWER WHEELCHAIR | ITI | 2009-04-10 |
| 15783 | 1860170252 | K083249 | QUICKIE RHYTHM | ITI | 2008-12-23 |
| 15783 | 1107226323 | K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | 2007-09-10 |
| 296575 | 1107226323 | K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | 2007-09-10 |
| 15783 | 1711242871 | K062701 | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR | ITI | 2006-09-25 |
| 15783 | 1182320017 | K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS | ITI | 2006-03-17 |
| 15783 | 1697058213 | K031289 | QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 | ITI | 2003-05-09 |
| 15783 | 1778049878 | K010917 | POWER TILT AND RECLINE SYSTEM | ITI | 2001-05-15 |
| 15783 | 1280754085 | K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | ITI | 2000-12-15 |
| 296575 | 1280754085 | K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | ITI | 2000-12-15 |
| 15771 | 1039665599 | ||||
| 15771 | 1327880876 | ||||
| 15771 | 1684364696 | ||||
| 15771 | 1866463150 | ||||
| 15771 | 1954559356 | ||||
| 15783 | 1039665599 | ||||
| 296575 | 1039665599 | ||||
| 15783 | 1048305773 | ||||
| 296575 | 1048305773 | ||||
| 296575 | 1078834290 | ||||
| 15783 | 1078834290 | ||||
| 296575 | 1082000471 | ||||
| 15783 | 1082000471 | ||||
| 15783 | 1220251387 | ||||
| 296575 | 1220251387 | ||||
| 15783 | 1327880876 | ||||
| 296575 | 1327880876 | ||||
| 15783 | 1465291111 | ||||
| 296575 | 1465291111 | ||||
| 15783 | 1549453843 | ||||
| 296575 | 1549453843 | ||||
| 296575 | 1612219782 | ||||
| 15783 | 1612219782 | ||||
| 15783 | 1676125530 | ||||
| 296575 | 1676125530 | ||||
| 15783 | 1684364696 | ||||
| 296575 | 1684364696 | ||||
| 296575 | 1718538539 | ||||
| 15783 | 1736872177 | ||||
| 296575 | 1736872177 | ||||
| 15783 | 1747692784 | ||||
| 296575 | 1747692784 | ||||
| 15783 | 1866463150 | ||||
| 296575 | 1866463150 | ||||
| 296575 | 1954559356 | ||||
| 15783 | 1954559356 | ||||
| 15783 | 1964861528 | ||||
| 296575 | 1964861528 | ||||
| 15783 | 2011546331 | ||||
| 296575 | 2011546331 | ||||
| 15783 | 2027812307 | ||||
| 296575 | 2027812307 |
Product Codes Associated With Registrations#
PMN#
Quickie(r) Q700-UP M
Sunrise Medical (US) LLC
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) And Zippie ZM-310 (Models BC, SC)
SUNRISE MEDICAL (US) LLC
Quickie, Zippie
Sunrise Medical (US) LLC
BREEZY ELEGANCE
SUNRISE MEDICAL (US) LLC
GUDID#
JAY LITEPRO CUSHION - Lightweight, low-profile, adjustable pressure-relieving cushion that offers a balance of skin protection and postural stability. Utilizing the latest 3D printing technology, paired with a multi-layered closed-cell foam base to create a cushion optimized for the active user. The perfect pairing for a Quickie, Sopur, or RGK ultralight wheelchair.
2026-03-05
RGK - RGK’s Octane is a completely bespoke ultra-light weight titanium wheelchair for experienced users which is tailored to your unique requirements, offering exceptional energy efficiency with eye catching design.
2023-09-05
RGK Octane Sub4 - The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - Titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about.
2023-09-05
RGK Octane FX - The RGK Octane FX is a made-to-measure chair unlike any other. Imagine a wheelchair that folds down so small you can store it in most airplane overhead luggage compartments. Imagine a wheelchair that is as lightweight and performance-oriented as a rigid sports chair.
2023-09-05
Quickie QX/QXi - The QUICKIE QXi is a durable, low-maintenance lightweight folding wheelchair that's perfect for the person looking for simplicity at the right price.
2021-05-04
Quickie SR45 - The QUICKIE® SR45 manual tilt wheelchair features 45° of Intelligent Rotation in Space Technology and a simplified mix of options for an outstanding value.
2021-05-04
Quickie Xtender - The Quickie® Xtender® electric assist wheelchair accessory expands the range of mobility for manual wheelchair users by adding power assisted wheels to a manual frame. The Xtender increases your travel distance and propulsion efficiency and reduces overall fatigue while allowing you to maintain the look, control, and functionality of a manual wheelchair.
2021-05-03
Cool Cube / TouchDrive 2 - The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions.The Switch-It TouchDrive2 (currently not in distribution) uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control.
2021-05-12
CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick - "Alternative drive controls for users who cannot use standard power wheelchair controls. Update: CTRL+5, Dual Pro and the MicroGuide will no longer use this UDI number. MicoPilot is no longer in distribution. The ""Brand Name"" section of this form cannot be edited after the initial publishing. "
2021-05-12
Jay Easy - The JAY® Easy® is a skin protection and positioning wheelchair cushion featuring a hi-resiliency, contoured foam base that accommodates a curved or flat seating surface and JAY Flow® fluid tripad.
2023-09-12
Jay Basic Back - The JAY® Basic wheelchair back is designed to increase sitting tolerance and stability by adding a rigid component to the wheelchair that provides long-term postural support.
2023-09-12
Jay Focus Point Back - "The JAY® Focus Point wheelchair back is a three-piece contoured backrest featuring a reinforced contoured aluminum shell, multi-adjustable lateral ""wings,"" and a pelvic wedge for additional posterior pelvic support."
2023-09-12
Jay Encompass Back - The JAY® Encompass is a fully configurable wheelchair back that offers a wide range of sizes and specifications, including made-to-order three-piece laterals and foam selections.
2023-09-12
Zippie Voyage - The Zippie Voyage® is a lightweight highly adjustable early intervention stroller. In addition to adjustable tilt and recline, the Voyage also features adjustable head supports, upper body supports and positioning straps. Comes with or without seating.
2023-09-12
Jay Fusion - The JAY Fusion® is an adjustable wheelchair cushion engineered to protect against pressure injuries that features the choice of JAY Flow® Fluid, JAY® Air™, or JAY Fluid with Cryo™ Technology insert options for optimal comfort and support.
2023-09-12
Switch-It - Alternative drive controls for users who cannot use standard power wheelchair controls.
2023-09-12
Xtreme X8 4WD - Through sand or snow and up or down curbs, the Extreme X8 is a true all-terrain power wheelchair. Unrivaled 4x4 off-road performance and reliability make it the perfect outdoor wheelchair for adventurers, explorers, and rural workers alike.
2023-09-12
Empluse - A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which the handlebar can steer. The device is attached to the wheelchair by a hook-and-latched subframe and a permanently installed wheelchair frame clamp.
2025-04-21
Quickie - A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or less.
2024-12-02
Empluse - The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over interior and exterior terrain.
2024-07-24
Empulse - The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
2024-06-26
Zippie GS - The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame wheelchair options to keep up with children's ever-changing lives.
2024-01-25
Zippie X'Cape - The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a rigid frame and the convenience of a folding frame.
2024-01-25
Quickie 5R - The Quickie® 5R is designed to deliver superior rigid wheelchair performance day after day. As you and your environment evolve, or as you refine your riding capabilities, the 5R's frame and components adjust to elevate your mobility.
2024-01-25
Zippie TS SE - The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, built-in growth, and compatible with many seating and positioning solutions, the TS has the widest variety of options in the tilt-in-space market.
2023-11-14
Switch-it - "The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggles, this box can be programmed to control up to 10 separate power seating functions! The Ctrl+5 is equipped with the R-NET bus connector, making setup a snap. Features a 4'8"" (150 cm) cable with R-NET male bus connector."
2023-11-14
Jay - "JAY® Fit Seating simplifies the world of made-to-order seating by offering a ""semi-personalized"" solution. A great option for individuals who require more complex seating than off-the-shelf options can provide that still allows for adjustments and growth."
2023-11-10
Jay - "JAY® Fit Seating simplifies the world of made-to-order seating by offering a ""semi-personalized"" solution. A great option for individuals who require more complex seating than off-the-shelf options can provide that still allows for adjustments and growth."
2023-11-10
Jay - The Jay Easy Back is designed to provide the important benefits of a proper back support for a wide variety of wheelchair users.It is designed to provide simple, comfortable and effective support to help maximise function and increase sitting tolerance. In addition, it is light-weight, durable and easy to use. The back can be installed onto a wide range of wheelchairs.
2023-11-10
Jay - Combining the high skin protection qualities of the JAY J2 wheelchair cushion with the stability and positioning capability of the J3, the JAY Balance wheelchair cushion adds exceptional comfort to ensure that there are no compromises.
2023-11-10
Jay - The JAY Xtreme Active is a lightweight and low profile wheelchair cushion for active performance and easy transfers. Designed to provide both pressure relief and stability to active users, the JAY fluid pad insert maximises skin protection and reduces shear on the active user. The dual cover system promotes air flow and dissipates heat and moisture effectively. Thigh positioning can be achieved through retrofittable leg support components.
2023-11-10
Jay - The J3 Back now offers a Carbon Fiber shell option for the ultimate in lightweight performance. Weighing as little as 2.2 lbs. when combined with RH hardware, the J3 Carbon Fiber Back is the perfect addition to any Quickie ultra lightweight wheelchair.
2023-11-10
Jay - For individuals who require a more complex seating solution, the JAY FIT 2U Back can be used when an off-the-shelf back cannot accommodate an individual’s orthopedic asymmetries or unique shape. For example, a client with a pronounced trunk rotation or fixed scoliosis requires multidimensional support. Unlike molded back supports, FIT 2U allows for adjustments to be made upon delivery and over time.
2023-11-10
Zippie X'Cape - The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a rigid frame and the convenience of a folding frame.
2023-10-09
Switch-It MicroGuide - The MicroGuide is a light-touch proportional power wheelchair drive control: the farther you push, the faster the chair will go. The device gives the user the ability to operate their wheelchair with 360° of control as well as the full range of the wheelchair's drive parameters (speed, acceleration, etc.).
2023-10-06
Switch-it MicroPilot - The MicroPilot is a proportional drive power wheelchair control. The device gives the user the ability to operate their power wheelchair with 360° of control as well as the full range of the wheelchair's drive parameters (speed, acceleration, etc.). Force-based technology enables users with minimal strength and without range of motion to drive their power wheelchair. Sensitivity adjustments allow control to be fine-tuned to each individual. Metal construction offers a significant durability advantage.
2023-10-06
Switch-It VersaGuide - The VersaGuide is a fully proportional and durable compact joystick that can be mounted virtually anywhere. Its unlimited mounting options are what give the versatile VersaGuide its name. The VersaGuide provides for proportional control (forward, reverse, left, and right). The VersaGuide EZ provides two built-in connections for mode and on/off on the underside of the joystick. Unique to the VersaGuide EZ is the SmartJack sensor input which will automatically adapt to both proximity and mechanical switches.
2023-10-06
Leckey Sleepform - Strong, durable, practical and adjustable sleeping system for kids aged 0-18 years.
2023-10-07
Leckey Squiggles Stander - Versatile, supportive, compact stander which gives children a whole new view of the world.
2023-10-07
Leckey Ealy Activity System - The Leckey Early Activity System is a Colorful, comfortable, supportive activity system for children aged 0-36 months.
2023-10-07