FDA.report

Action®

Primary DI
00089904002471
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Wheelchair Cushion
Catalog number
9000I
Device description
The Pilot™
Published
2021-02-03
Public version status
New
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

Contact Domains

Product Codes

CodeName
KICCushion, Flotation

Product Code Classifications

CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00089904002471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904002471000899040024710899040024710089904002471

GMDN Terms

TermDefinition
Gel-filled chair cushionA gel-filled 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Minimal UV exposure
Special Storage Condition, Specify00Store in clean, dry environment

Sterilization Methods

Method

Contacts

PhoneEmail
301.797.1414service@actionproducts.com

Regulatory Flags

DUNS number
067543058
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00089904004109Action®Seating SystemX12122021-02-09
00089904004130Action®Seating SystemX1214R2021-02-09
00089904004208Action®Seating SystemX1416R2021-02-09
00089904004215Action®Seating SystemX1416S2021-02-09
00089904004253Action®Seating SystemX1616R2021-02-09
00089904004277Action®Seating SystemX1618R2021-02-09
00089904004345Action®Seating SystemX18182021-02-09
00089904004413Action®Seating SystemX2018R2021-02-09
00089904004550Action®Seating SystemXS18202021-02-09
00089904004567Action®Seating SystemXS20162021-02-09
00089904004710Action®Seating SystemXL20182021-02-09
00089904004727Action®Seating SystemXSM16182021-02-09
00089904004734Action®Seating SystemXSM16162021-02-09
00089904004772Action®Seating SystemX2018D2021-02-09
00089904004840Action®Seating SystemXS2020R2021-02-09
00089904005014Action®Seating SystemXS1818R2021-02-09
00089904006646Action®Seating SystemX1414R2021-02-09
00089904006691Action®Seating SystemX1614R2021-02-09
00089904006714Action®Seating SystemX1616D2021-02-09
00089904006837Action®Seating SystemX2018S2021-02-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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