FDA.reportPublic FDA data

Malem

Primary DI
05060049630144
Brand
Malem
Company
MALEM MEDICAL LIMITED
Model
PC9S
Device description
Queen's Square Bladder Stimulator - Selectable (PC9S)
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060049630144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060049630144050600496301445060049630144

GMDN Terms#

Term, Definition table
TermDefinition
Bladder-emptying vibratory stimulatorA battery-powered, hand-held device intended to be used in the home or healthcare facility by a patient to help initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. It is an electronic unit with a handle and massaging head held against the skin surface that is typically used by patients who have problems voiding due to disorders of neuromuscular origin (e.g., multiple sclerosis).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
291490076
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060049630038MalemMO3S12016-08-31
05060049630045MalemMO48T2016-08-31
05060049630052MalemMO5M2016-08-31
05060049630069MalemMO62016-08-31
05060049630076MalemMO72016-08-31
05060049630120MalemMO4SB2016-08-31
05060049630151MalemMO122016-08-31
05060049630168MalemMO152016-08-31
05060049630182MalemMO172016-08-31
05060049630205MalemMO38T2016-08-31
05060049630212MalemMO3S22016-08-31
05060049630229MalemMO3S32016-08-31
05060049630236MalemMO38TC2016-08-31
05060049630243MalemMO3V2016-08-31
05060049630250MalemMO4S12016-08-31
05060049630267MalemMO4S22016-08-31
05060049630274MalemMO4S32016-08-31
05060049630281MalemMO5B2016-08-31
05060049630298MalemMO4SM2016-08-31
05060049630304MalemMO4SC2016-08-31

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