Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008656885

FEI Number

3008656885

Entity Name

Fludra Sp. z.o.o.

City/State/Country

Sroda Wielkopolska Wielkopolskie, PL

Establishment Address

ul. Harcerska 18E, Sroda Wielkopolska Wielkopolskie 63-000, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

THOMASHILFEN (Owner Number: 9034645)

Owner / Operator Contact Address

WALKMUEHLENSTRASSE 1, --, BREMERVOERDE, DE-NI 27432, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swifty 3 ThevoTherapy Swifty 2 EASyS Advantage Swifty EASyS Modular S tRide ThevoSiiS ThevoTwist Simplex bath chair Seat depth reducer under seat storage basket Seat width reducer Chin support Lateral trunk support, swing away Drum brake kit Rain cape, poncho Crotch pad incl. magnetic lock Pelvic belt Hi/low indoor base Arm rest Crotch strap Head pillow Pneumatic wheels Design package tRide Headrest standard Adapter Q-chassis Sun/Rain cover Straps - wrist "runaway" tether Advantage chassis Sleeping bag Tip assist Calf strap canopy for legs Vent tray Chest Harness Mouting hardware special headrest Lateral head support Headrest shell Straps - secure folded seat/frame Footrest tube upholstery Hip belt Rain shield Medical necessity pack Q-chassis Rain canopy Lateral trunk support Push bar Seat minimizer upholstery Leg blanket Head rest front wheels Impulse sensors, lateral back wheels Bus tie-downs Cargo basket Headrest adjustable winged Frame padding Soft pelvic harness Belt bow Footrest pad Trunk pads Foot strap Side paddings basket Headrest neck support Abduction block Grab bar Umbrella Sun and rain canopy Tray EASyS adapter Q-chassis Butterfly chest harness Pelvis support Z-chassis Incontinence seat pad 5-point harness under seat storage bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2005-06-01
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2021-05-19
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2005-06-01

Official Correspondent

Hans-Georg Hoeft

US Agent Details

Darlene Hawthorne Business: EXOMOTION LLC. Email: hans-georg.hoeft@thomashilfen.de Phone: (866) 8702122

Related Public Records

Same Entity

THOMASHILFEN

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615019	THOMASHILFEN	BREMERVOERDE Lower Saxony, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008656885. Last updated year: 2026. Please use registration number 3008656885 when referencing this establishment in official correspondence.