FDA.reportPublic FDA data

Action®

Primary DI
00089904008817
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Seating System Cover
Catalog number
COBXSM1616
Device description
Xact® Soft SL Cover
Published
2021-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089904008817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904008817000899040088170899040088170089904008817

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

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
06972077026587EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-15
06972077026365EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026372EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026389EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026396EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026457EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026464EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026471EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026488EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026495EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026334EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026358EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082689077Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082695511Spex SeatingSPEX LIMITEDKNN2026-04-30
06934726614484Battery ChargerLongfian Scitech Co., Ltd.KNN2026-04-25
10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
05407008321222mo-vismo-VisKNN2025-11-19
05407008321239mo-vismo-VisKNN2025-11-19
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051725195Spex LimitedSPEX LIMITEDKNN2025-11-07