Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004730053

FEI Number

3004730053

Entity Name

ETAC AB

City/State/Country

KISTA Stockholm, SE

Establishment Address

KISTA SCIENCE TOWER, KISTA Stockholm 164 51, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ETAC AB (Owner Number: 9065893)

Owner / Operator Contact Address

KISTA SCIENCE TOWER, --, KISTA, SE-NOTA 164 51, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Brake lever extension Beauty comb Beauty hair brush Beauty kit Handrim Cane holder Cross Headrest Safety belt Belt Butler buttoner Socky stocking aid Swift shower stool Swift freestanding toilet seat Easy shower stool Rufus bath chair Edge shower stool Rufus shower chair foldb recess Swift shower chair Swift commode Smart shower stool Relax shower stool wall mounted Components Clean Tripp Etac Swift Mobil Tilt-2 XL Etac Swift Mobil 24"-2 Etac Swift Mobil-2 Etac Swift Mobil Tilt-2 Etac Swift Mobil-2 XL Back Clean 24" Swift Mobil Swift Mobil 160 Widening kit Swift Mobil ri/le Attachment pan and bucket Cross bar Clean Seat cover Swift Mobil Head rest Tripp Soft seat Tripp Leg and calf support Tilter Swift Mobil Clean Comfort Kit Anti tip Swift Mobil Heightening spacers Clean Splash cover Swift Mobil Comfort seat Swift Mobil Chest harness belt Cushion Clean Protect Trunk support Swift Mob/Clean Positioning belt Heel straps Swift Mobil Castors Clean lockable 80 mm Hemiplegia armrest Safety belt Clean/Mobil/Tipp Comfort cover Clean Torkel toiletpaper tongs Support handle Fresh Armrest Swift Beauty back washer Pan incl lid with handle Pan and lid Clean Cross bar Pan holder Clean Backrest Swift Soft seat Clean Leg and calf support Clean Soap dish Lid with handle for pan Beauty hair washer Rear wheel adapter Clean Bathboard Fresh Pan holder Soft backrest Clean Pan Lid for seat Clean Toilet armrests Supporter Comfort seat Clean Wire kit Swift Mobil tilt-2 Toilet seat raiser Cloo Castor 125 lockable white pair front Extensions Clean for low pan Neckrest Swift Mobil Soft back Swift Extensions for low pan/bucket Footrest leg and calf support Soft back pad Swift Mobil Soft cushion Universal Comfort cover Swift Mobil Soft seat oval opening Soft back Tripp Adjustable Supporter Back cushion Tripp Footrest foldable Clean Bucket holder grey Soft seat cushion Tripp Armrest pad Clean pair Armrest lock Swift Mobil Bathboard Rufus 68 cm Rear wheel kit Swift Mobil Anti tip Cross Anti tip Star stabil-air StarLock Star standard air Aktiv reacher Beauty multi purpose grip Uni universal grip Tasty beaker Cut cutting aid Light spoon/knife Tasty plate Light dessertspoon Light knife Light fork Feed spoon Light spoon Relieve knife Fix preparation board Relieve cheese slicer Light knife/fork Feed fork Tasty goblet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
ILW	Adaptor, Grooming	Physical Medicine	Class 1	890.5050	2004-08-16
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2004-08-16
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2013-03-26
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2004-08-16
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2004-08-16
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2004-08-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-08-16
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2004-08-16
IKW	Utensil, Homemaking	Physical Medicine	Class 1	890.5050	2004-08-16
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2004-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

Dennis Lutz Business: D.T. DAVIS ENTERPRISES LTD. Email: spavelko@hovermatt.com Phone: (610) 4433414

Related Public Records

Same Entity

ETAC AB

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004730053. Last updated year: 2026. Please use registration number 3004730053 when referencing this establishment in official correspondence.