FDA.reportPublic FDA data

Action®

Primary DI
00089904006677
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Seating System
Catalog number
X1515S
Device description
Xact® Classic
Published
2021-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCushion, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089904006677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904006677000899040066770899040066770089904006677

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in clean, dry environment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301.797.1414service@actionproducts.com

Regulatory Flags#

DUNS number
067543058
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089904002297Action®Mattress Overlay6400H2021-02-03
00089904002310Action®Mattress Overlay6405H2021-02-03
00089904002280Action®Mattress Overlay64002021-01-21
00089904002303Action®Mattress Overlay64052021-01-21
00089904011374Action®OR Table Replacement Pad70915A2026-01-08
00089904011381Action®OR Table Replacement Pad779102026-01-08
00089904011398Action®OR Table Replacement Pad55915C2026-01-08
00089904011367Action®OR Table Replacement Pad75910D2025-11-18
00089904000958Action®Arm Pad403122021-01-11
00089904011350Action®OR Table Replacement Pad57140C2025-08-28
00089904011343Action®OR Table Replacement Pad721402025-01-06
00089904011336Action®OR Table Replacement Pad57310C2024-09-10
00089904009531Action®Disposable Cover40616DC2021-01-14
00089904009548Action®Disposable Cover40617DC2021-01-14
00089904009555Action®Disposable Cover40618DC2021-01-14
00089904009562Action®Disposable Cover40619DC2021-01-14
00089904009579Action®Disposable Cover40620DC2021-01-14
00089904009586Action®Disposable Cover40621DC2021-01-14
00089904000231Action®Disposable Cover40102I2021-01-14
00089904000422Action®Disposable Cover401022021-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
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09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07