Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003947878

FEI Number

3003947878

Entity Name

PRESSALIT

City/State/Country

Ry Midtjylland, DK

Establishment Address

Pressalitvej 1, Ry Midtjylland 8680, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pressalit (Owner Number: 10036566)

Owner / Operator Contact Address

Pressalitvej 1, Ry, DK-82 8680, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCT 1000 / SCT 2000 / SCT 2100 / SCT 3000 CT 4000 / CT 4100 MCT 2 MSCT 1 MCT 3 MSCT 4 MCT 5 SCT 1000 SCT 3000 SCT 2000 CT 5000 SELECT TL1 toilet lifter SELECT TL2 toilet lifter SELECT TL4 toilet lifter SELECT TL3 toilet lifter Grab bar (support arm), foldable, 700 mm Grab bar (support arm), foldable, 850 mm Shower seat 450, manually height adjustable, with and without back and arm rest, seat with and without aperture. Shower seat 310, fixed height/manually height adjustable, with and without back and armrest. Backrest, 300 mm, soft feel, fixed height/sideways adjustable/height adjustable. Folding seat, fixed height/height adjustable Shower seat 450, powered incl. wired hand control/remote control, height adjustable 500 mm, with back- and armrests, sea

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2011-06-01
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2024-10-30
INT	Plinth	Physical Medicine	Class 1	890.3520	2011-06-01
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2018-04-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2011-11-18
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2011-11-18

Official Correspondent

Dorthe Rask Jensen

US Agent Details

Darrell Burnette Email: darrell@max-ability.com Phone: (202) 2710166

Related Public Records

Same Entity

Pressalit

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Similar Registrations

Registration Number	Establishment Name	Location
3008899703	HAVEN MEDICAL, LLC	Grand Haven, MI, US
3008887767	TYROMOTION GMBH	Graz Steiermark, AT
3016678044	ETAC POLAND SP. Z O.O.	Tczew Pomorskie, PL
2510425	Hill Laboratories	Frazer, PA, US
3008261413	DJO CANADA INC.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003947878. Last updated year: 2026. Please use registration number 3003947878 when referencing this establishment in official correspondence.