203-5 SHOWER CHAIR

GUDID 08055715702833

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.

ORMESA SRL

Shower seat, non-powered
Primary Device ID08055715702833
NIH Device Record Key61ef57d4-7653-4eac-bbb3-8196c2c89f63
Commercial Distribution StatusIn Commercial Distribution
Brand Name203-5 SHOWER CHAIR
Version Model Number203-5 SHOWER CHAIR
Company DUNS432070019
Company NameORMESA SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108055715702833 [Primary]

FDA Product Code

INMChair, With Casters

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31

Devices Manufactured by ORMESA SRL

08055715700006 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700013 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700020 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700037 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700044 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700051 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700068 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin
08055715700075 - GRILLO 2025-02-10 Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and settin

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