FDA.reportPublic FDA data

EMYS

Primary DI
08055774710695
Brand
EMYS
Company
TARTA DESIGN SRL
Model
E3XL-S
Device description
Emys- Backrest 3 vert – Size XL – Standard*
Published
2021-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMSSupport, Head And Trunk, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055774710695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055774710695080557747106958055774710695

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430766724
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055774710985TARTA KIDTKID01-G2021-05-01
08055774711012TARTA KID PROKP012021-05-01
08055774711029TARTA KID PROKP022021-05-01
08055774710954TARTA KIDTKWHCAS2021-05-01
08055774710961TARTA KIDTKSGAS2021-05-01
08055774711036TARTA KID PROKPSGAS2021-05-01
08055774710657EMYSE3M-S2021-05-01
08055774710664EMYSE3M-C2021-05-01
08055774710671EMYSE3L-S2021-05-01
08055774710688EMYSE3L-C2021-05-01
08055774710701EMYSE3XL-C2021-05-01
08055774710718EMYSE4M-S2021-05-01
08055774710725EMYSE4M-C2021-05-01
08055774710732EMYSE4M-D2021-05-01
08055774710749EMYSE4L-S2021-05-01
08055774710756EMYSE4L-C2021-05-01
08055774710763EMYSE4L-D2021-05-01
08055774710770EMYSE4XL-S2021-05-01
08055774710787EMYSEX4L-C2021-05-01
08055774710794EMYSE4XL-D2021-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004033Side Mount Headrest Interface PlateMotion Concepts IncIMS2026-05-19
10194484321953CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322059CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322073CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322080CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322097CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322103CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322110CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322127CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322134CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322141CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322158CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322165CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322189CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322196CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322202CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322219CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322226CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322233CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322240CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322257CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22