FDA.reportPublic FDA data

Assista-Rail

Primary DI
00689281001472
Brand
Assista-Rail
Company
Healthcraft Products Inc.
Model
AST-S
Catalog number
00147
Device description
The Assista-Rail is a fixed bed rail. The Assista-Rail is intended ONLY for minimal vertical load bearing to provide bed positioning and seating support for people with reduced mobility. The Assista-Rail is intended for home use. The Assista-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. The Assista-Rail is height adjustable to accommodate the thickness of the mattress. The maximum user weight for this product is 300lbs / 136kgs. Product is not intended to support full body weight.
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10689281001479PackageGS14In Commercial Distribution
00689281001472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068928100147910689281001479
00689281001472006892810014726892810014720689281001472

GMDN Terms#

Term, Definition table
TermDefinition
Bedrail"A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an ""up"" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint."

Regulatory Flags#

DUNS number
252468293
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00689281037396Wave Grab Bar, 18" Length, Left and Right, Matte Black (2 pk)WGB-18-LR-BLK037392026-10-13
00689281037402Wave Grab Bar, 18" Length, Left and Right, Brushed Stainless (2 pk)WGB-18-LR-BS037402026-10-13
00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)WGB-18-LR-CP037412026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackWGB-18-L-BLK038062026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessWGB-18-L-BS038072026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldWGB-18-L-GD038082026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeWGB-18-L-CP038092026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)WGB-18-LR-GD038342026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeWGB-18-L-ORB039412026-10-13
00689281039604Easy Mount™ Grab Bar, Modular L-Shape, 1.25x16x16", KnurledMLGB-16x16-SK039602026-10-08
00689281039611Easy Mount™ Grab Bar, Modular L-Shape, 1.25x24x16", KnurledMLGB-24x16-SK039612026-10-08
00689281039628Easy Mount™ Grab Bar, Modular L-Shape, 1.25x30x30", KnurledMLGB-30x30-SK039622026-10-08
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)GB-12-SK-BAG038412026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)GB-18-SK-BAG038422026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)GB-24-SK-BAG038432026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)GB-32-SK-BAG038442026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)GB-12-BLK-T039252026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)GB-24-BLK-T039262026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackGB-18-BLK008002026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackGB-24-BLK008012026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281037396Wave Grab Bar, 18" Length, Left and Right, Matte Black (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281037402Wave Grab Bar, 18" Length, Left and Right, Brushed Stainless (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackHealthcraft Products Inc.IKX2026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessHealthcraft Products Inc.IKX2026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldHealthcraft Products Inc.IKX2026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeHealthcraft Products Inc.IKX2026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-10-13
00810226442962ViveVIVE HEALTH LLCIKX2026-10-12
00689281039604Easy Mount™ Grab Bar, Modular L-Shape, 1.25x16x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039611Easy Mount™ Grab Bar, Modular L-Shape, 1.25x24x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039628Easy Mount™ Grab Bar, Modular L-Shape, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledHealthcraft Products Inc.IKX2026-09-30