FDA.reportPublic FDA data

R82

Primary DI
05707292794024
Brand
R82
Company
R82 A/S
Model
Meerkat SIZE-1
Catalog number
870011-2
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INWTABLE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INWTable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707292794024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707292794024057072927940245707292794024

GMDN Terms#

Term, Definition table
TermDefinition
Manual standerA manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
308022169
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05715393055838R82x:panda shape infant L, w/belt91020000111042026-03-26
05715393078868R82x:panda shape infant L, no belt90020000030042026-03-26
05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05707292610744R82Cricket SIZE-1870431002022-10-12
05707292610751R82Cricket SIZE-2870432002022-10-12
05715393012275R82Flamingo Curo SIZE-18820012025-09-01
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05707292620989R82Scallop 1991051-1CR21F2022-10-12
05707292620996R82Scallop 1991051-1CR43F2022-10-12
05707292621009R82Scallop 2991051-2CR21F2022-10-12
05707292621016R82Scallop 2991051-2CR43F2022-10-12
05707292621047R82Scallop 3991051-3R21F2022-10-12
05707292621054R82Scallop 3991051-3R43F2022-10-12
05707292621085R82Scallop 4991051-4R21F2022-10-12
05707292621092R82Scallop 4991051-4R43F2022-10-12
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077026532PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026563PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026570PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026594SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026600SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026617SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026624SPECIALTYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026631CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026648CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026655JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
06972077026662JOYXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-15
00815235022617UMF MedicalUNITED METAL FABRICATORS, INC.INW2026-05-14
06972077026433ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026440ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026549ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026556PROHEALXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-07
06972077026259EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026280EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026297EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026303EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026761EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026778EmeraldXIAMEN TAFT MEDICAL CO.,LTD.INW2026-05-06
06972077026174CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026181CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026211CostcareXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
06972077026310ProactiveXIAMEN TAFT MEDICAL CO.,LTD.INW2026-04-24
05715393022809R82R82 A/SINW2026-01-20
05715393022816R82R82 A/SINW2026-01-20
05715393022823R82R82 A/SINW2026-01-20
05715393022830R82R82 A/SINW2026-01-20