Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027241818

FEI Number

3027241818

Entity Name

Kimball Electronics - Mexico SA de CV

City/State/Country

Reynosa Tamaulipas, MX

Establishment Address

Ave. Los Robles No. 200 Parque Industrial Center, Ciudad, Reynosa Tamaulipas 88780, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KIMBALL SOLUTIONS GROUP, LLC (Owner Number: 9071700)

Owner / Operator Contact Address

1205 Kimball Blvd., Jasper, IN 47546, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HomeFill Oxygen System PreciseRX Pediatric Flowmeter HomeFill Oxygen System Platinum 5NXG Oxygen Concentrator Platinum Mobile Oxygen Concentrator Platinum Oxygen Concentrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2024-02-22
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-04-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-05-12
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-05-12
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-05-11
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

LOLA STEWARD Business: KIMBALL ELECTRONICS GROUP, LLC Email: Lola.Steward@Kimballelectronics.com Phone: (812) 6344172

Related Public Records

Same Entity

KIMBALL SOLUTIONS GROUP, 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
3008253300	Kimball Solutions Jasper, Inc.	Jasper, IN, US
3008058135	Kimball Electronics Poland Sp.z o.o	Tarnowo Podgorne Wielkopolskie, PL
3003660459	Kimball Electronics - Thailand LTD	Thungsukhla Sriracha Chon Buri, TH
3004598644	Kimball Electronics - Indianapolis	Indianapolis, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027241818. Last updated year: 2026. Please use registration number 3027241818 when referencing this establishment in official correspondence.