FDA.reportPublic FDA data

ZEUS

Primary DI
05904569152246
Brand
ZEUS
Company
AETHER BIOMEDICAL SP Z O O
Model
Zeus V1
Catalog number
A-01-R
Device description
ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand intended to be used with other appropriate upper limb components to form a complete arm prosthesis, to be fitted only by qualified and certified clinicians. It should be used only by upper limb (forearm). Zeus V1 is suitable for 3 amputation levels: below-elbow, above-elbow and shoulder. For right hand.
Published
2022-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05904569152246PackageGS11In Commercial Distribution
05904569152239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904569152246059045691522465904569152246
05904569152239059045691522395904569152239

GMDN Terms#

Term, Definition table
TermDefinition
Electrical hand prosthesisAn 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 moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. The control of the motor is through an electromechanical switch operated by body movement using straps or cables.

Sterilization Methods#

Method table
Method

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
true
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
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
05904569152215ZEUSZeus V1A-01-L2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08057971594702Analog Amplifier with accessoriesBIONIT LABS SRLIQZ2026-03-20
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 SRLIQZ2026-03-18
09421037390413TASKA PowerCore System, BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421037390420TASKA PowerCore System, SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785005TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785012TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785029TASKA HandGen2 Myoelectric Hand - 8 1/4 RH LP SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785036TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785043TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785050TASKA HandGen2 Myoelectric Hand - 8 1/4 RH QWD SandTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785067TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP WhiteTASKA PROSTHETICS LIMITEDIQZ2026-01-07
09421906785074TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP BlackTASKA PROSTHETICS LIMITEDIQZ2026-01-07