Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006750942

FEI Number

3006750942

Entity Name

MOTEK MEDICAL B.V.

City/State/Country

Houten Noord-Brabant, NL

Establishment Address

Vleugelboot 14,, Houten Noord-Brabant 3991 CL, NL

Establishment Type(s)

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

Owner / Operator

MOTEK MEDICAL B.V. (Owner Number: 9105520)

Owner / Operator Contact Address

Vleugelboot 14,, --, Houten, NL-NOTA 3991 CL, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GRAIL CAREN SYSTEM M-Gait C-Mill Monitored Rehab Systems "Functional Squat" Monitored Rehab System "Cable Column" RYSEN MR Cube Body Weight Support Light

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOL	Treadmill, Powered	Physical Medicine	Class 1	890.5380	2007-08-08
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2020-12-02
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2017-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

MOTEK MEDICAL B.V.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006750942. Last updated year: 2026. Please use registration number 3006750942 when referencing this establishment in official correspondence.