Data / Medical devices / Mexico / Sunrise Medical Tecnologias, S.A. de CV

Sunrise Medical Tecnologias, S.A. de CV: FDA-registered device maker in Tijuana Baja California, Mexico, 1 510(k) clearance

Name: Sunrise Medical Tecnologias, S.A. de CV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sunrise Medical Tecnologias, S.A. de CV is registered with the FDA (registration 3039359026) in Tijuana Baja California, Mexico. It lists 18 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2000. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3039359026
Address: 22260 Sin Calle El Realito, Tijuana Baja California, Mexico, 22250
Owner or operator: Sunrise Medical (US) LLC (9019832)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: October 7, 1992
Registered through: 2026
Brand names listed: BeMe Seating System, CTRL+5, Cool Cube, Dual Pro, Empulse R20, Everyday Activity Seat, Forward Cushion Cover, outer, Freestander and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Contract manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Contract manufacturer	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Contract manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Contract manufacturer	accessdata.fda.gov
Board, Lap, Wheelchair	IMX	1	Contract manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Contract manufacturer	accessdata.fda.gov
Chair, With Casters	INM	1	Contract manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Contract manufacturer	accessdata.fda.gov
Cushion, Flotation	KIC	1	Contract manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Contract manufacturer	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Contract manufacturer	accessdata.fda.gov
Handrim, Wheelchair	IMO	1	Contract manufacturer	accessdata.fda.gov
Holder, Crutch And Cane, Wheelchair	IMZ	1	Contract manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Contract manufacturer	accessdata.fda.gov
Support, Head And Trunk, Wheelchair	IMS	1	Contract manufacturer	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Contract manufacturer	accessdata.fda.gov
Wheelchair, Powered	ITI	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 15, 2000	K001491	QUICKIE 2 POWER ASSIST WHEELCHAIR	ITI	Substantially Equivalent	Sunrise Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 15, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.