FDA.reportPublic FDA data

Action®

Primary DI
00089904003997
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Wheelchair Back Rest
Catalog number
TCMT
Device description
Twister® Wheelchair Back - Tall
Published
2021-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00089904003997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904003997000899040039970899040039970089904003997

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

Storage And Handling#

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

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089904003966Action®Wheelchair Back RestTCAS2021-02-09
00089904003973Action®Wheelchair Back RestTCAT2021-02-09
00089904003980Action®Wheelchair Back RestTCMS2021-02-09
00089904004000Action®Wheelchair Back RestTCNS2021-02-09
00089904004017Action®Wheelchair Back RestTCNT2021-02-09
00089904004024Action®Wheelchair Back RestTCWS2021-02-09
00089904004031Action®Wheelchair Back RestTCWT2021-02-09
00089904004468Action®Seating SystemXL16182021-02-09
00089904008169Action®Wheelchair Back RestPHT19202021-02-09
00089904008183Action®Wheelchair Back RestPHS17182021-02-09
00089904008190Action®Wheelchair Back RestPHS19202021-02-09
00089904008206Action®Wheelchair Back RestPHS21232021-02-09
00089904008213Action®Wheelchair Back RestPHT15162021-02-09
00089904008220Action®Wheelchair Back RestPHT17182021-02-09
00089904008237Action®Wheelchair Back RestPHT21232021-02-09
00089904008244Action®Wheelchair Back RestTCAS17182021-02-09
00089904008251Action®Wheelchair Back RestTCAT17182021-02-09
00089904008268Action®Wheelchair Back RestTCMS19202021-02-09
00089904008275Action®Wheelchair Back RestTCMT19202021-02-09
00089904008282Action®Wheelchair Back RestTCNS15162021-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147004040Matrx MAC BackMotion Concepts IncIMP2026-07-03
07540147004057Matrx MAC-HUG BackMotion Concepts IncIMP2026-07-03
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
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