FDA.report

Oakworks Medical

Primary DI
00817463020007
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
CFPM401 Standard
Device description
CFPM401 Standard
Published
2019-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IXRTable, Radiographic, Tilting

Product Code Classifications

CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817463020007PrimaryGS10

GMDN Terms

TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods

Method

Regulatory Flags

DUNS number
130256837
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
true
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 DIBrandModelCatalogPublished
00817463026719Physical Therapy SeriesPT100 Table2023-08-08
00817463027242Procedure Chair -Acccessory871082023-12-13
00817463027235Procedure Chair-Accessory862412023-12-07
00817463026405Imaging and Pain ManagementCFPM Series Accessory2023-12-06
00817463026412Imaging and Pain ManagementCFPM Series Accessory2023-12-06
00817463026429Imaging and Pain ManagementCFPM Series Accessory2023-12-06
00817463026436Imaging and Pain ManagementCFPM Series Accessory2023-12-06
00817463027082Oakworks Accccessory747582023-12-06
00817463027105Oakworks Accessory871142023-12-06
00817463027112Ultrasound Product Line Accessory634872023-12-06
00817463027129Oakworks Acccessoory849432023-12-06
00817463027136 Powerline Acessory44677 2023-12-06
00817463027143Powerline Series Accessory519102023-12-06
00817463027150Ultrasound Product Line Acccessory831392023-12-06
00817463027167Oakworks Accessory734552023-12-06
00817463027174Oakworks Portable series Accessory635302023-12-06
00817463027198100 series Acessory71976 2023-12-06
00817463027204Physical Therapy (PT) product line Accessory721782023-12-06
00817463027211Physical Therapy (PT) product line722032023-12-06
00817463027228Physical Therapy (PT) product line Accessory180762023-12-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00817463026405Imaging and Pain ManagementOAKWORKS, INC.IXR2023-12-06
00817463026412Imaging and Pain ManagementOAKWORKS, INC.IXR2023-12-06
00817463026429Imaging and Pain ManagementOAKWORKS, INC.IXR2023-12-06
00817463026436Imaging and Pain ManagementOAKWORKS, INC.IXR2023-12-06
00817463026184Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026214Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026221Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026238Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026252Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026276Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026306Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026313Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463026320Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-17
00817463025941Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-11
00817463025972Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463025989Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026054Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026061Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026092Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026177Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026245Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026269Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026283Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026290Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10
00817463026337Imaging and Pain ManagementOAKWORKS, INC.IXR2023-07-10