FDA.reportPublic FDA data

ZEUS

Primary DI
05905515340717
Brand
ZEUS
Company
AETHER BIOMEDICAL SP Z O O
Model
A02L-MF0B
Device description
Zeus V2 is a multi-action bionic limb. The fingers and thumb provide a firm grasp to perform everyday tasks with ease. The fingers stall individually, allowing them to conform to the shape of the object, regardless of shape or size. The bionic upper limb fills its functions and helps to perform all required tasks thanks to compatible Software
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQZHand, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQZHand, External Limb Component, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05905515340717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05905515340717059055153407175905515340717

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
850705379
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05905515340793MyoSenseAET-SEN-2NM2026-10-08
05905515340618ZEUSA02L-SF0B2026-10-07
05905515340632ZEUSA02R-SF0B2026-10-07
05905515340731ZEUSA02R-MF0B2026-10-07
05905515340755ZEUSA02L-SF1B2026-10-07
05905515340779ZEUSA02R-SF1B2026-10-07
05905515340816ZEUSA02L-MF1B2026-10-07
05905515340830ZEUSA02R-MF1B2026-10-07
05904569152291ZEUSA-01-L-T2023-03-24
05905515340014ZEUSA-01-R-T2023-03-19
05904569152253Aether Digital PlatformW-ADP2023-10-31
05904569152260Aether Digital PlatformM-ADP2023-10-31
05904569152208ZEUSZeus V1A-01-L2022-04-15
05904569152239ZEUSZeus V1A-01-R2022-04-19
05904569152222Aether Battery SystemAET-BAT-BS12023-01-31
05905515340007ZEUSA-01-L-T2023-03-24
05905515340021ZEUSA-01-R-T2023-03-19
05904569152246ZEUSZeus V1A-01-R2022-04-19
05904569152215ZEUSZeus V1A-01-L2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05905515340793MyoSenseAETHER BIOMEDICAL SP Z O OIQZ2026-10-08
05905515340618ZEUSAETHER BIOMEDICAL SP Z O OIQZ2026-10-07
05905515340632ZEUSAETHER 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
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
08057971595785Pulse PackBIONIT LABS SRLIQZ2026-07-06
04064411004343Myo PlusOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411004350Myo PlusOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411005524Myo Plus TROtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411005531Myo Plus TROtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411007672myosmart.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008105myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008112myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008129myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411008136myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009041myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411009058myosmart.cuffOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411010856myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013697myosmart trial kitOtto Bock Healthcare Products GmbHIQZ2026-05-04
04064411013772connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04
04064411014144connectgrip.Otto Bock Healthcare Products GmbHIQZ2026-05-04