FDA.reportPublic FDA data

LEON Multifunctional shower chair

Primary DI
04260681890253
Brand
LEON Multifunctional shower chair
Company
BEKA Hospitec GmbH
Model
920124500
Device description
Multifunctional shower chair
Published
2025-03-31
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
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260681890253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260681890253042606818902534260681890253

GMDN Terms#

Term, Definition table
TermDefinition
Shower seat, power-adjustedAn electrically-powered device designed to be sat upon by a patient (adult or child) while washing in a bath, shower, or other washing facility. The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device is typically in the form of a fixed seat (e.g., wall-mounted) with powered controls to adjust position (typically height), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials. It may be used in a hospital, institution, or home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342212273
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260681890161MILO Multifunctional shower chair9201240002025-03-31
04260681890192JAMES Multifunctional shower chair 9201250002025-03-31
04260681890222Nora Pro Stand Aid 9210780002025-03-31
04260735020001EVE! Bathing Lift9201070002025-03-31
04260735020025EVE! Bathing Lift9201080002025-03-31
04260735020063Senta Bathing Lift9201010082025-03-31
04260735020070Senta Bathing Lift920101008R2025-03-31
04260735020087Senta Bathing Lift920101008RS2025-03-31
04260735020094Senta Bathing Lift920101008S2025-03-31
04260735020315Nora ALU Stand Aid 9210710082025-03-31
04260735020322Nora ALU Stand Aid9210710182025-03-31
04260735020346Nora ALU Stand Aid9210740082025-03-31
04260735020407Nora Pro Stand Aid 9210770002025-03-31
04260735020490Carlo Classic ALU Patient Lift9240032082025-03-31
04260735020506Carlo Classic ALU Patient Lift924003208S2025-03-31
04260735020605Carlo Classic ALU Patient Lift9240015082025-03-31
04260735020629Carlo Classic ALU Patient Lift9240030082025-03-31
04260735020636Carlo Classic ALU Patient Lift924003008S2025-03-31
04260735020742Carlo Alu Comfort EP Patient Lift9250060082025-03-31
04260735020759Carlo Alu Comfort EP Patient Lift925006008S2025-03-31

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