FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G0648317270046640PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
847-328-9540info@positionhealthusa.com

Regulatory Flags

DUNS number
116685742
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DIBrandModelCatalogPublished
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
G0648317270064770HEELIFT GLIDE® 8317270064778317270064772022-12-09

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