FDA.reportPublic FDA data

203-5 SHOWER CHAIR

Primary DI
08055715702833
Brand
203-5 SHOWER CHAIR
Company
ORMESA SRL
Model
203-5 SHOWER CHAIR
Device description
Push wheelchair intended for the personal hygiene operations of users with disabilities, , semi-self-sufficient or non-self-sufficient users with poor head and trunk control, tending to lose contact with the surface of the backrest and slide with the pelvis forward and who assistance assistance in the care and hygiene of their own person to maintain stability and safety for the user and the assistant.
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715702833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715702833080557157028338055715702833

GMDN Terms#

Term, Definition table
TermDefinition
Shower seat, non-poweredA non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432070019
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040402029FRAME RUNNERFRAME RUNNER SMALL 2R24’’ 1R20’’2025-10-15
08054040402036FRAME RUNNERFRAME RUNNER SMALL 3R20’’2025-10-15
08054040401275FRAME RUNNER"FRAME RUNNER MEDIUM FISS.3R24"""2025-09-20
08054040401282FRAME RUNNER"FRAME RUNNER LARGE FISS.3R26"" "2025-09-20
08054040401299FRAME RUNNERFRAME RUNNER MEDIUM RIBALT.3R24 2025-09-20
08054040401305FRAME RUNNERFRAME RUNNER LARGE RIBALT.3R262025-09-20
08054040401312FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R24""1R20"""2025-09-20
08054040401329FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R24""1R20"""2025-09-20
08054040401336FRAME RUNNER"FRAME RUNNER MEDIUM FISS.2R26""1R24"""2025-09-20
08054040401343FRAME RUNNER"FRAME RUNNER MEDIUM RIB.2R26""1R24"""2025-09-20
08054040401350FRAME RUNNERFRAME RUNNER LARGE FISS.3R242025-09-20
08054040401367FRAME RUNNERFRAME RUNNER LARGE RIB.3R242025-09-20
08054040401374FRAME RUNNER"FRAME RUNNER LARGE FISS.2R26""1R24"""2025-09-20
08054040401381FRAME RUNNER"FRAME RUNNER LARGE RIB.2R26""1R24"""2025-09-20
08054040401398FRAME RUNNER"FRAME RUNNER LARGE FISS.2R24""1R26"""2025-09-20
08054040401404FRAME RUNNER"FRAME RUNNER LARGE RIB.2R24""1R26"""2025-09-20
08054040401411FRAME RUNNER"FRAME RUNNER LARGE FISS.2R28""1R26"""2025-09-20
08054040401428FRAME RUNNER"FRAME RUNNER LARGE RIB.2R28""1R26"""2025-09-20
08054040401435FRAME RUNNERFRAME RUNNER LARGE FISS.3R282025-09-20
08054040401442FRAME RUNNERFRAME RUNNER LARGE RIB.3R282025-09-20

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