Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005150489

FEI Number

3005150489

Entity Name

Huka B.V.

City/State/Country

Oldenzaal Overijssel, NL

Establishment Address

Munsterstraat 13, Oldenzaal Overijssel 7575 ED, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huka B.V. (Owner Number: 9072816)

Owner / Operator Contact Address

Munsterstraat 13, --, Oldenzaal, NL-OV 7575 ED, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K913759

PMA Number

N/A

All Registered Proprietary Names

huka

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2007-11-14

Official Correspondent

Rogier Halink

US Agent Details

Werner Frank Business: Mobility & Access, Inc. Email: wfrank@mobilityaccess.com Phone: (724) 6951590

Related Public Records

Same Entity

Huka B.V.

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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005150489. Last updated year: 2026. Please use registration number 3005150489 when referencing this establishment in official correspondence.