FDA.reportPublic FDA data

SuperPole FRS with SuperBar

Primary DI
00689281035866
Brand
SuperPole FRS with SuperBar
Company
Healthcraft Products Inc.
Model
FRS-SPB
Catalog number
03596
Device description
The SuperPole F.R.S. (floor receptacle system) with SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole F.R.S. (a support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor). The horizontal bar can be lifted, pivoted, and lowered to the next locking position around the F.R.S. pole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole F.R.S. by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves strong enough for the SuperBar to support the user. When the SuperPole F.R.S. is removed from the concrete receptacle, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00689281035866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281035866006892810358666892810358660689281035866

GMDN Terms#

Term, Definition table
TermDefinition
Hand railA device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.

Sterilization Methods#

Method table
Method

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
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"GB-12-BS037342026-04-14
00689281010382e2™ Ceiling Mount Trapeze with 24 in. Grab BarSTP-CM-24010382021-08-25
00689281010450e2™ Ceiling Mount Trapeze with 32 in. Grab BarSTP-CM-32010452021-08-25
00689281037204PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037228PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
00689281037235PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
00689281037242PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
00689281037259PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
00689281037266PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
00689281037303"Easy Mount™ Grab Bar, 1.25x12"", Oil Rubbed Bronze"GB-12-ORB 037302024-01-29
00689281037310"Easy Mount™ Grab Bar, 1.25x18"", Oil Rubbed Bronze"GB-18-ORB037312024-01-29
00689281037327"Easy Mount™ Grab Bar, 1.25x24"", Oil Rubbed Bronze"GB-24-ORB037322024-01-29
10689281037201PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037211PLUS Shampoo Shelf + Grab Bar, Oil Rubbed BronzePLUS-SHS-ORB037212024-01-29
10689281037225PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
10689281037232PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
10689281037249PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
10689281037256PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
10689281037263PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
10689281037300Easy Mount™ Grab Bar, 1.25x12", Oil Rubbed BronzeGB-12-ORB 037302024-01-29

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