FDA.reportPublic FDA data

KNEE SEPARATOR

Primary DI
G0648317270046640
Brand
KNEE SEPARATOR
Company
POSITION HEALTH, LLC
Model
831727004664
Catalog number
831727004664
Device description
KNEE SEPARATOR, Leg/Knee Cushion (One Size)
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0648317270046640PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Leg/knee cushionA soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-328-9540info@positionhealthusa.com

Regulatory Flags#

DUNS number
116685742
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0648317270013971TurnAssist®8317270013978317270013972022-12-09
G064108317270090000ELBOWLIFT®10831727009000108317270090002022-12-09
G064108317270093210HEELIFT® TRACTION10831727009321108317270093212022-12-09
G064208317270091511CastWedge™20831727009151208317270091512022-12-09
G064208317270092051CastWedge™20831727009205208317270092052022-12-09
G064208317270092501CastWedge™ 20831727009250208317270092502022-12-09
G064208317270093041CastWedge™20831727009304208317270093042022-12-09
G064208317270097860HEELIFT® 20831727009786208317270097862022-12-09
G0648317270013731TurnAssist®8317270013738317270013732022-12-09
G0648317270013970TurnAssist®8317270013978317270013972022-12-09
G0648317270016631ULNAR NERVE PROTECTOR8317270016638317270016632022-12-09
G0648317270038580HEELIFT GLIDE® 8317270038588317270038582022-12-09
G0648317270041140HEEL/ELBOW PROTECTOR8317270041148317270041142022-12-09
G0648317270052030HEELIFT GLIDE® Ultra8317270052038317270052032022-12-09
G0648317270053020HEELIFT AFO® Ultra 8317270053028317270053022022-12-09
G0648317270054010HEELIFT GLIDE® Ultra8317270054018317270054012022-12-09
G0648317270055000HEELIFT GLIDE® Ultra8317270055008317270055002022-12-09
G0648317270062790HEELIFT GLIDE® 8317270062798317270062792022-12-09
G0648317270064530HEELIFT GLIDE® 8317270064538317270064532022-12-09
G0648317270064600HEELIFT GLIDE® 8317270064608317270064602022-12-09

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07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
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00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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