FDA.report

Raizer

Primary DI
05060572010369
Brand
Raizer
Company
THE KIRTON HEALTHCARE GROUP LIMITED
Model
II
Catalog number
105029
Device description
A battery powered device to raise a person from the floor to a seated position.
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060572010369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060572010369050605720103695060572010369

GMDN Terms

TermDefinition
Patient fall-recovery chair, electricAn electrically-powered device designed to enable one person to lift an incapacitated or disabled patient safely and with minimal physical effort from a supine position on the floor (e.g., following a fall) to a seated position. Sometimes referred to as an emergency lifting chair, it consists of a motorized seat with detachable legs and back supports, and a seatbelt, intended to be assembled beneath the patient like a scoop stretcher, prior to lifting them to a seated position using an electronic controller. It is intended for use in both the home and clinical setting.

Sterilization Methods

Method

Regulatory Flags

DUNS number
291031631
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060407340005Mercury Advance Control Unit StandardPUM122024-07-12
05060572010352RaizerM1050402024-07-12
05060572019928Mercury Advance MattressStandardMAT122024-07-12

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