FDA.reportPublic FDA data

Myo Plus

Primary DI
04064411004350
Brand
Myo Plus
Company
Otto Bock Healthcare Products GmbH
Model
560X18-1=IOS
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04064411004350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064411004350040644110043504064411004350

GMDN Terms#

Term, Definition table
TermDefinition
External limb prosthesis adjustment softwareA software program designed for use with an electronic external limb prosthesis intended to enable the amputee and clinician to adjust the prosthesis settings (e.g., motion control preferences, programming of pre-set modes for different activities). It is intended to be used on a non-medical computerized device (e.g., smartphone, tablet) for wireless communication with the prosthesis.

Regulatory Flags#

DUNS number
300802068
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064411004343Myo Plus560X18-1=ANDR2026-05-04
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
04064411009041myosmart.cuff757M20-2=50-S2026-05-04
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
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
05905515340793MyoSenseAETHER BIOMEDICAL SP Z O OIQZ2026-10-08
05905515340618ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340632ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340717ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340731ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340755ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340779ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340816ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340830ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
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