Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019677893

FEI Number

3019677893

Entity Name

Sunrise Medical (US) LLC

City/State/Country

Mount Juliet, TN, US

Establishment Address

12002 Volunteer Blvd, Mount Juliet, TN 37122, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Sunrise Medical (US) LLC (Owner Number: 9019832)

Owner / Operator Contact Address

12002 Volunteer Blvd, Mount Juliet, TN 37122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983639

PMA Number

N/A

All Registered Proprietary Names

Quickie Quickie Quickie Zippie Magic Mobility Quickie Zippie LUCI Switch-It Leckey MyWay MyWay+ Whitmyer Jay Octane Octane FX Octane SUB4 Tiga FX Tiga SUB4 Tiga Hilite Veypr SUB4 Quickie Xtender Empulse M90 Quickie Quickie Q500 M Quickie Q300 M Quickie Q200 R Quickie Q500 H Quickie Q700-UP M Quickie Q700 M Quickie Zippie Zippie Quickie Ride Custom Back Ride Custom Cushion Pre-Sewn Forward Cushion Cover, outer Ride Java Cushion Ride Decaf Java Back BeMe Seating System Dual Pro Joystick In A Can Cool Cube MyGo Seating System LUCI Squiggles Seating System CTRL+5 VersaGuide Empulse R20 Switch-It Switch-It Vigo MyGo Seat Ride Forward Cushion, Inner Ride Java Back Q50 R Carbon X8 Extreme 4x4 VOYAGE MIGHTY LITE STROLLER MyGo Stander Squiggles Seat Horizon Stander Pronestander Freestander Squiggles Stander Squiggles TT Stander Squiggles Plus Stander Totstander Everyday Activity Seat KID KART STROLLER Frontier V6 Frontier V4 RWD Frontier V4 FWD Frontier Zippie Quickie QXi Sleepform Pal Early Activity System Advance Bath Chair Extreme X8 ZIPPIE GS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2007-08-15
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2004-01-05
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2007-08-15
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2007-08-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	1992-12-07
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2005-09-19
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2004-01-05
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-08-11
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2008-07-23
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-08-22
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2005-09-19
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2015-12-04
IPL	Wheelchair, Standup	Physical Medicine	Class 2	890.3900	2018-08-08
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2007-08-15
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2007-08-01
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	1992-10-07
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2023-11-07
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-08-22
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2005-09-14
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-11-24
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2007-08-01
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2008-07-23
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-01-05
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-11-24
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2007-08-15

Official Correspondent

Neeraj Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sunrise Medical (US) LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681189	James Leckey Design Ltd	Lisburn Lisburn and Castlereagh, GB
3039359026	Sunrise Medical Tecnologias, S.A. de CV	Tijuana Baja California, MX
2937137	SUNRISE MEDICAL (US) LLC	FRESNO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

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2937137	SUNRISE MEDICAL (US) LLC	FRESNO, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019677893. Last updated year: 2026. Please use registration number 3019677893 when referencing this establishment in official correspondence.