Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038189190

FEI Number

3038189190

Entity Name

CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD

City/State/Country

Wetherill Park New South Wales, AU

Establishment Address

11 Daniel Street, Wetherill Park New South Wales 2164, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Concourse Assistive Technology PTY LTD (Owner Number: 10092945)

Owner / Operator Contact Address

11 Daniel Street, Wetherill Park, AU-NSW 2164, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242327

PMA Number

N/A

All Registered Proprietary Names

Sunrise medical (US)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-03-09

Official Correspondent

Alex Suen

US Agent Details

Neeraj Patel Business: SUNRISE MEDICAL (US) LLC Email: tanisha.gregory@sunmed.com Phone: (803) 5717205

Related Public Records

Same Entity

Concourse Assistive Technology PTY LTD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

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.

Similar Registrations

Registration Number	Establishment Name	Location
3045076265	BEIJING ORIONSTAR TECHNOLOGY CO., LTD.	Beijing, CN
3006160539	LOH ENTERPRISES, LLC	Clarks Summit, PA, US
3002667030	TUNG KENG ENTERPRISE CO., LTD.	Taichung City, TW
3043165991	HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.	SHIJIAZHUANG Hebei, CN
3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038189190. Last updated year: 2026. Please use registration number 3038189190 when referencing this establishment in official correspondence.