FDA.reportPublic FDA data

Traction frame

Primary DI
04527799700387
Brand
Traction frame
Company
PARAMOUNT BED CO., LTD.
Model
KA-86U
Device description
Electrical Hospital Bed Accessory to be used for patient traction at medical institutions.
Published
2020-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04527799700387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04527799700387045277997003874527799700387

GMDN Terms#

Term, Definition table
TermDefinition
Bed traction frameAn adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690552500
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04527799706549A6 Electrical Hospital Bed with Digital ScalePA-H6D582025-12-01
04527799706556A6 Electrical Hospital Bed with Digital ScalePA-H6D5C2025-12-01
04527799706563A6 Electrical Hospital Bed with Digital ScalePA-H6D5A2025-12-01
04527799706570A6 Electrical Hospital Bed with Digital ScalePA-H6D5B2025-12-01
04527799706624A6 Electrical Hospital Bed with Digital ScalePA-H6D682025-12-01
04527799706631A6 Electrical Hospital Bed with Digital ScalePA-H6D6C2025-12-01
04527799706648A6 Electrical Hospital Bed with Digital ScalePA-H6D6A2025-12-01
04527799706655A6 Electrical Hospital Bed with Digital ScalePA-H6D6B2025-12-01
04527799706709A6 Electrical Hospital Bed with Digital ScalePA-H6D58X2025-12-01
04527799706716A6 Electrical Hospital Bed with Digital ScalePA-H6D5CX2025-12-01
04527799706723A6 Electrical Hospital Bed with Digital ScalePA-H6D5AX2025-12-01
04527799706730A6 Electrical Hospital Bed with Digital ScalePA-H6D5BX2025-12-01
04527799706785A6 Electrical Hospital Bed with Digital ScalePA-H6D68X2025-12-01
04527799706792A6 Electrical Hospital Bed with Digital ScalePA-H6D6CX2025-12-01
04527799706808A6 Electrical Hospital Bed with Digital ScalePA-H6D6AX2025-12-01
04527799706815A6 Electrical Hospital Bed with Digital ScalePA-H6D6BX2025-12-01
04527799707188A6 Electrical Hospital BedPA-H6C182025-12-01
04527799707195A6 Electrical Hospital BedPA-H6C1C2025-12-01
04527799707201A6 Electrical Hospital BedPA-H6C1A2025-12-01
04527799707218A6 Electrical Hospital BedPA-H6C1B2025-12-01

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