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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Regulatory Flags#

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040402029FRAME RUNNERFRAME RUNNER SMALL 2R24’’ 1R20’’2025-10-15
08055715701171BIRILLOBIRILLO-12025-01-31
08055715701188BIRILLOBIRILLO-22025-01-31
08055715701195BIRILLOBIRILLO-32025-01-31
08055715701201BIRILLOBIRILLO-42025-01-31
08055715704820CLIPCLIP-12025-01-31
08055715704837CLIPCLIP-22025-01-31
08055715704844CLIPCLIP-32025-01-31
08055715704851CLIPCLIP-42025-01-31
08055715708569BIKOBIKO MINI BLU PIGN. FISSO2025-01-31
08055715708576BIKOBIKO MINI BLU RUOTA LIBERA2025-01-31
08055715708606BIKOBIKO MINI ROSSO PIGN. FISSO2025-01-31
08055715708613BIKOBIKO MINI ROSSO RUOTA LIBERA2025-01-31
08055715708620BIKOBIKO SMALL BLU DIFF.PIGN.FISSO2025-01-31
08055715708637BIKOBIKO SMALL BLU DIFF.RUOTA LIBERA2025-01-31
08055715708644BIKOBIKO SMALL BLU PIGN.FISSO2025-01-31
08055715708651BIKOBIKO SMALL BLU RUOTA LIBERA2025-01-31
08055715708705BIKOBIKO SMALL ROSSO DIFF.PIGN.FISS02025-01-31
08055715708712BIKOBIKO SMALL ROSSO DIFF.RUOTA LIBERA2025-01-31
08055715708729BIKOBIKO SMALL ROSSO PIGN. FISSO2025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408784ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408791ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408807ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00841447116479Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116486Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116493Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116509Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116516Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116523Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00193489028754GUARDIANMEDLINE INDUSTRIES, INC.INM2026-04-02
00884389150835MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150802MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150819MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408357ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408364ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408371ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408388ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408395ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408401ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408418ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408425ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408432ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408449ConvaidCONVAID PRODUCTS, INC.INM2026-02-05