FDA.report

Star Lock

Primary DI
00840363367415
Brand
Star Lock
Company
KI MOBILITY, LLC
Model
Star Lock Cushion
Catalog number
ESSL51620-1IC
Device description
Star Lock Cushion 16" x 20" x 5" with Incontinent Cover
Published
2024-01-02
Public version status
New
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

Product Codes

CodeName
KICCUSHION, FLOTATION

Product Code Classifications

CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840363367415PrimaryGS10

GMDN Terms

TermDefinition
Air-filled chair cushionA static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)981-1540sales@kimobility.com

Regulatory Flags

DUNS number
609305656
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
00840363365404AxiomPXPLPXPL10102024-01-08
00840363365411AxiomPXPLPXPL10122024-01-08
00840363365428AxiomPXPLPXPL10142024-01-08
00840363365435AxiomPXPLPXPL12122024-01-08
00840363365442AxiomPXPLPXPL12142024-01-08
00840363365459AxiomPXPLPXPL12162024-01-08
00840363365466AxiomPXPLPXPL14122024-01-08
00840363365473AxiomPXPLPXPL14142024-01-08
00840363365480AxiomPXPLPXPL14162024-01-08
00840363365497AxiomPXPLPXPL16142024-01-08
00840363365503AxiomPXPLPXPL16162024-01-08
00840363365510AxiomPXPLPXPL16182024-01-08
00840363365527AxiomPXALPXAL10102024-01-08
00840363365534AxiomPXALPXAL10122024-01-08
00840363365541AxiomPXALPXAL10142024-01-08
00840363365558AxiomPXALPXAL12122024-01-08
00840363365565AxiomPXALPXAL12142024-01-08
00840363365572AxiomPXALPXAL12162024-01-08
00840363365589AxiomPXALPXAL14122024-01-08
00840363365596AxiomPXALPXAL14142024-01-08

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Primary DIBrandCompanyProduct codePublished
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00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114992ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115005ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115012ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115029ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115036ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115043ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115050ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115067ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115074ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115081ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115098ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115104ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732115111ROHO LOW PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09