FDA.reportPublic FDA data

Myo Plus

Primary DI
04064411004343
Brand
Myo Plus
Company
Otto Bock Healthcare Products GmbH
Model
560X18-1=ANDR
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
04064411004343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064411004343040644110043434064411004343

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
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
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
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
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08