FDA.report

SuperPole™ FRS Floor Receptacle

Primary DI
00689281005050
Brand
SuperPole™ FRS Floor Receptacle
Company
Healthcraft Products Inc.
Model
FRS-FR
Catalog number
00505
Device description
The SuperPole FRS is a high quality, commercial grade support receptacle that is permanently embedded into a structural concrete floor to be used exclusively with the SuperPole FRS-Pole. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, 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. The SuperPole F.R.S. is not to be used in any other way than described
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00689281005050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281005050006892810050506892810050500689281005050

GMDN Terms

TermDefinition
Fixed-rail armrestA wall and/or floor fixed-rail system designed to provide arm support for a disabled person to facilitate their movement/mobility. It is permanently-fixed to the wall and/or floor at strategic points in a building or in the home.

Sterilization Methods

Method

Regulatory Flags

DUNS number
252468293
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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