FDA.reportPublic FDA data

myosmart.cuff

Primary DI
04064411009041
Brand
myosmart.cuff
Company
Otto Bock Healthcare Products GmbH
Model
757M20-2=50-S
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064411009041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064411009041040644110090414064411009041

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.

Regulatory Flags#

DUNS number
300802068
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064411004343Myo Plus560X18-1=ANDR2026-05-04
04064411004350Myo Plus560X18-1=IOS2026-05-04
04064411005524Myo Plus TR13E5202026-05-04
04064411005531Myo Plus TR13E520=OB2026-05-04
04064411007672myosmart.13E522=12026-05-04
04064411008105myosmart.cuff757M20-2=502026-05-04
04064411008112myosmart.cuff757M20-2=50-OB2026-05-04
04064411008129myosmart.cuff757M20-2=602026-05-04
04064411008136myosmart.cuff757M20-2=60-OB2026-05-04
04064411009058myosmart.cuff757M20-2=60-S2026-05-04
04064411010856myosmart trial kit642V64=T-SMART-OB2026-05-04
04064411013697myosmart trial kit642V64=T-SMART-S2026-05-04
04064411013772connectgrip.560X27-1=ANDR2026-05-04
04064411014144connectgrip.560X27-1=IOS2026-05-04
04064411004800Electrode13E200=502020-03-19
04064411004824Electrode13E200=602020-03-19
04064411004848Suction Socket Electrode13E202=502020-03-19
04064411004879Suction Socket Electrode13E202=602020-03-19
04064411005159Remote Electrode13E400=G140-502020-03-19
04064411005166Remote Electrode13E400=G140-50-OB2020-03-19

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