FDA.reportPublic FDA data

Wave Electrode with accessories

Primary DI
08057971592876
Brand
Wave Electrode with accessories
Company
BIONIT LABS SRL
Model
AE02-60
Device description
Wave Electrode, 60 Hz with accessories - cable length 100 cm
Published
2025-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08057971592876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057971592876080579715928768057971592876

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 moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. 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
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3908361946903support@bionitlabs.com
+1 (877)4246648na_support@bionitlabs.com

Regulatory Flags#

DUNS number
439080477
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057971595785Pulse PackVF012026-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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