FDA.reportPublic FDA data

Analog Amplifier with accessories

Primary DI
08057971594641
Brand
Analog Amplifier with accessories
Company
BIONIT LABS SRL
Model
AA03-60
Device description
Analog Amplifier, 60 Hz
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
IQZHand, External Limb Component, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242326000Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl2025-01-02GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057971594641PackageGS11In Commercial Distribution
08057971594085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057971594641080579715946418057971594641
08057971594085080579715940858057971594085

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric hand prosthesisA powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
439080477
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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
08057971594795Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594801Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594818Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-20
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08057971594733Remote Wave ElectrodeBIONIT LABS SRLIQZ2026-03-18
08057971594603Adam's HandBIONIT LABS SRLIQZ2025-12-17
08057971592463Adam's HandBIONIT LABS SRLIQZ2025-11-21
08057971593989Adam's SkinBIONIT LABS SRLIQZ2025-11-21
08057971594870Adam's HandBIONIT LABS SRLIQZ2025-11-05
08057971591442Adam's SkinBIONIT LABS SRLIQZ2025-10-28
08057971593781Adam's SkinBIONIT LABS SRLIQZ2025-10-28
08057971594085Analog Amplifier with accessoriesBIONIT LABS SRLIQZ2025-08-25
08057971594856Adam's HandBIONIT LABS SRLIQZ2025-07-11
08057971593804Adam's HandBIONIT LABS SRLIQZ2025-05-08
08057971593774Adam's HandBIONIT LABS SRLIQZ2025-04-03
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08057971592685Wave ElectrodeBIONIT LABS SRLIQZ2025-01-21
08057971590964Wave Electrode with accessoriesBIONIT LABS SRLIQZ2025-01-21
08057971590971Wave Electrode with accessoriesBIONIT LABS SRLIQZ2025-01-21
08057971592692Wave ElectrodeBIONIT LABS SRLIQZ2025-01-21
08057971592876Wave Electrode with accessoriesBIONIT LABS SRLIQZ2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08057971592449Adam's HandBIONIT LABS SRLIQZ2024-09-06