FDA.reportPublic FDA data

Remote Wave Electrode

Primary DI
08057971594801
Brand
Remote Wave Electrode
Company
BIONIT LABS SRL
Model
AE03-60
Device description
Remote Wave Electrode, 60 Hz with accessories - cable length 60 cm
Published
2026-03-20
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
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
K260453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260453000Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl2026-03-12GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057971594801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057971594801080579715948018057971594801

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
+1 (877)4246648na_support@bionitlabs.com

Regulatory Flags#

DUNS number
439080477
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057971595792Adam's Hand PlusAH03-LS1-W1-012026-08-07
08057971595808Adam's Hand PlusAH03-RS1-W1-012026-08-07
08057971595815Adam's Hand PlusAH03-LS1-B1-012026-08-07
08057971595822Adam's Hand PlusAH03-RS1-B1-012026-08-07
08057971596416Adam's Hand PlusAH03-LS1-W1-01-D2026-08-07
08057971596423Adam's Hand PlusAH03-RS1-W1-01-D2026-08-07
08057971595785Pulse PackVF012026-07-06
08057971594702Analog Amplifier with accessoriesAA03-602026-03-20
08057971594795Remote 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08057971595792Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971595808Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971595815Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971595822Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971596416Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08057971596423Adam's Hand PlusBIONIT LABS SRLIQZ2026-08-07
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
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
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08