FDA.reportPublic FDA data

VELA Samba

Primary DI
05714339016599
Brand
VELA Samba
Company
Vermund Larsen A/S
Model
410
Device description
Stool, 5 wheels, upholstered seat
Published
2024-01-24
Public version status
New
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
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714339016599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714339016599057143390165995714339016599

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose stool/chairA seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305793176
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
05714339121033VELA Rumba87214 Treatment chair2025-06-10
05714339123358VELA Rumba87215 Treatment chair2025-06-10
05714339126410VELA Tango5108 VELA Bariatric chair2025-06-10
05714339918169VELA MW4MS011200 Meywalk Medium2025-06-10
05714339918237VELA MW4MS011250 Meywalk 4 Large2025-06-10
05714339918244VELA MW4MS013000 Meywalk 4 Small2025-06-10
05714339918251VELA MW4MS014000 Meywalk 4 Micro2025-06-10
05714339918268VELA MW2000MS104173 Meywalk 2000 Large2025-06-10
05714339918275VELA MW2000MS104175 Meywalk 2000 Medium2025-06-10
05714339918282VELA MW2000MS104500 Meywalk 2000 Small2025-06-10
05714339918299VELA MiniwalkMS106061 Miniwalk size 12025-06-10
05714339918305VELA MiniwalkMS106062 Miniwalk size 22025-06-10
05714339026017VELA Rumba872112024-01-24
05714339056748VELA Tango300E2024-01-24
05714339057066VELA Samba80141 Samba 1102024-01-24
05714339057257VELA Rumba872122024-01-24
05714339058537VELA Tango310E2024-01-24
05714339062008VELA Tango70030 X-ray Chair2024-01-24
05714339062206VELA Tango70031 'Turn+' Thorax Chair2024-01-24
05714339062220VELA Tango70033 'Basic+' Ophthalmology Chair2024-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
00628758009009ZwimRaz Design IncINN2024-11-06
00850010988702Mor-Medical New EraMoroles Investments, LLCINN2024-07-16
10197344018840MEDLINEMEDLINE INDUSTRIES, INC.INN2024-06-26
00628758001027JazRaz Design IncINN2024-06-12
00628758002024JazRaz Design IncINN2024-06-12
05056235203858Jenx JENX LIMITEDINN2024-05-10
05056235203865Jenx JENX LIMITEDINN2024-05-10
05056235203872Jenx JENX LIMITEDINN2024-05-10
05056235203889Jenx JENX LIMITEDINN2024-05-10
05056235203896Jenx JENX LIMITEDINN2024-05-10
05056235203902Jenx JENX LIMITEDINN2024-05-10
05056235203919Jenx JENX LIMITEDINN2024-05-10