FDA.report

Action®

Primary DI
00089904006622
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Seating System
Catalog number
X1212S
Device description
Xact® Classic
Published
2021-02-09
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
IMPCushion, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00089904006622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904006622000899040066220899040066220089904006622

GMDN Terms

TermDefinition
Wheelchair cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair. It may be used to improve posture, provide back and/or side support, compensate for seat height, relieve stress points, and provide pressure alleviation for the buttocks, lumbar region, and the legs, and/or to provide an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Storage And Handling

TypeLowHighCondition
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

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