FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463025576
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
EA Vascular Table with Fowler (V2 Model)
Device description
"Vascular Table with Fowler Backrest, Cardio with Right back Support; 30"" Width; 240V Electric Ultrasound (EA) Ergonomics Advantage Series "
Published
2023-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463025576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463025576008174630255768174630255760817463025576

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130256837
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
00817463026412Oakworks Medical Adjustable T-Rail Clamp Accessory-12in2023-12-06
00817463026870Oakworks Medical PT300 Table2023-10-03
00817463026887Oakworks Medical PT300 Table2023-10-03
00817463025361Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
00817463025378Oakworks Medical Ultrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks Medical Ultrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks Medical Ultrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks Medical Ultrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks Medical PT300 Table2023-10-02
00817463026931Oakworks Medical PT400 Table2023-10-02
00817463026948Oakworks Medical PT400 Table2023-10-02
00817463026955Oakworks Medical PT400 Table2023-10-02
00817463026979Oakworks Medical PT400M Table2023-10-02
00817463025484Oakworks Medical Ultrasound EA General 3 Section Table or Multi-Spe2023-09-29
00817463025491Oakworks Medical Ultrasound EA General 3 Section Table or Women's (2023-09-29
00817463025507Oakworks Medical Ultrasound EA General 3 Section Table2023-09-28
00817463025569Oakworks Medical Ultrasound EA Vascular Table2023-09-28
00817463025606Oakworks Medical Ultrasound EA Vascular Table2023-09-28
00817463026634Oakworks Medical Powerline Backrest Top Exam Table2023-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
00728564057000Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564057017Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058007Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058014Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060000Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065005Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065012Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068006Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068013Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564157007Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564157014Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
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00728564165019Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564168003Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564168010Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10