FDA.reportPublic FDA data

Zwim

Primary DI
00628758009009
Brand
Zwim
Company
Raz Design Inc
Model
Zwim
Catalog number
EP900
Device description
Individually configured, mobile and stationary commode chairs for use during showering and toileting. Zwim is a Self-Propel Mobile Shower / Pool (Commode) Chair with an aluminum frame.
Published
2024-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628758009009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628758009009006287580090096287580090090628758009009

GMDN Terms#

Term, Definition table
TermDefinition
Commode, manualA non-active, manually-operated transportable device in the form of a chair with a receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4167515678npang@razdesigninc.com
4167515678arahat@razdesigninc.com

Regulatory Flags#

DUNS number
206941366
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628758002000RazRaz-SP2023-08-01
00628758004448RazRaze2025-05-28
00062875800444RazRazeZ4442025-03-11
00628758001881TrakzTrakz-AP2024-04-02
00628758003885TrakzTrakz-AT2024-04-02
00628758001003RazRaz-AP2023-08-01
00628758001058EZPZEZPZ-AP2023-08-01
00628758001119RazRaz ZÜM-AP2023-08-01
00628758001607RazRaz-AP6002023-08-01
00628758002055EZPZEZPZ-SP2023-08-01
00628758002222RazRaz ZÜM-SP2023-08-01
00628758002604RazRaz-SP6002023-08-01
00628758003007RazRaz-AT2023-08-01
00628758003038RazRaz-CAT2023-08-01
00628758003052EZPZEZPZ-AT2023-08-01
00628758003335RazRaz-ART2023-08-01
00628758003601RazRaz-AT6002023-08-01
00628758001027JazJaz-AP2024-06-12
00628758002024JazJaz-SP2024-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
05715393055838R82R82 A/SINN2026-03-26
05715393078868R82R82 A/SINN2026-03-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00860014545825Peri-Chair LLCPERI-CHAIR, LLCINN2025-10-15
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
05707581000751Shower SeatRopox A/SINN2022-12-08
05707581000768Shower SeatRopox A/SINN2022-12-08
05707581000775Shower SeatRopox A/SINN2022-12-08
05707581000782Shower SeatRopox A/SINN2022-12-08
07320451321794Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451321817Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451351173Etac Supply Center ABEtac Supply Center ABINN2022-12-08
00850001752169Compass Chair Size 1RIFTON EQUIPMENTINN2022-09-16
00850001752176Compass Chair Size 2RIFTON EQUIPMENTINN2022-09-16