FDA.reportPublic FDA data

EMYS

Primary DI
08055774710916
Brand
EMYS
Company
TARTA DESIGN SRL
Model
AH/PGV-LB
Device description
Emys- High adjustable clamp for folding wheelchair with rigidizer bar - Size L BLACK COLOUR
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
08055774710916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055774710916080557747109168055774710916

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back rest positionerA bracket-like device intended to be attached to the back canes of a wheelchair to accept the wheelchair back rest (not included) and allow for the adjustment of the back rest position (e.g., angle, depth, height). It is typically in the form of a clamp with hooks of adjustable position/orientation; pins intended to secure positioning may also be included. This is a reusable device.

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
08055774710695EMYSE3XL-S2021-05-01
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

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
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10194484322240CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322257CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22