FDA.reportPublic FDA data

Myo Unit

Primary DI
08057971591053
Brand
Myo Unit
Company
BIONIT LABS SRL
Model
MU01-01
Device description
Device for displaying surface EMG signal intensity from active electrodes
Published
2024-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCJDevice, Skin Potential Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCJDevice, Skin Potential MeasurementNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057971592739PackageGS11In Commercial Distribution
08057971591053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057971592739080579715927398057971592739
08057971591053080579715910538057971591053

GMDN Terms#

Term, Definition table
TermDefinition
ElectromyographAn electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+3908361946903support@bionitlabs.com

Regulatory Flags#

DUNS number
439080477
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057971594702Analog Amplifier with accessoriesAA03-602026-03-20
08057971594795Remote Wave ElectrodeAE03-602026-03-20
08057971594801Remote Wave ElectrodeAE03-602026-03-20
08057971594818Remote Wave ElectrodeAE03-602026-03-20
08057971594733Remote Wave ElectrodeAE03-602026-03-18
08057971594085Analog Amplifier with accessoriesAA03-602025-08-25
08057971594689Analog Amplifier with accessoriesAA03-602025-08-06
08057971594696Analog Amplifier with accessoriesAA03-602025-08-06
08057971594603Adam's HandAH02-RS3-B1-012025-12-17
08057971594566Adam's HandAH02-RS3-B1-012025-12-17
08057971593897Adam's SkinAS02-LS1-N12025-12-02
08057971593903Adam's SkinAS02-RS1-N12025-12-02
08057971592463Adam's HandAH02-RM3-B1-012025-11-21
08057971593989Adam's SkinAS02-RS1-N52025-11-21
08057971594870Adam's HandAH02-RM3-W1-01-L2025-11-05
08057971591442Adam's SkinAS02-LM1-N52025-10-28
08057971593781Adam's SkinAS02-LS1-A02025-10-28
08057971595358MyoLogicML02-012025-09-26
08057971595365MyoLogic ProML01-012025-09-26
08057971594009Adam's SkinAS02-RS1-N62025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971592739Myo UnitBIONIT LABS SRLHCJ2024-11-13
06975980570000MEICETShanghai May Skin Information Technology Co., Ltd.HCJ2023-01-30
06975980570017MEICETShanghai May Skin Information Technology Co., Ltd.HCJ2023-01-28