MyoSense

Primary DI
05905515340793
Brand
MyoSense
Company
AETHER BIOMEDICAL SP Z O O
Model
AET-SEN-2NM
Device description
Aether MyoSense is a device for integration into a prosthetic system, measuring the sEMG (surface Electromyography) signal, enabling control of the end device, e.g., a prosthetic hand. The device is equipped with two high-impedance differential inputs for measuring the sEMG signal using dry passive electrodes connected by connection cables terminated with ring terminal connectors. The device has 5 leads connected to dry passive electrodes (so-called dome electrodes) placed in the prosthetic socket (in contact with the skin), of which 4 leads constitute the input of two differential channels, and the fifth lead constitutes the DRL (Drive Right Leg) output, which sets the operating point of the measuring amplifier. The device is equipped with a BLE module that allows for sEMG signal monitoring and adjusting of the settings. The device has two analog outputs (so-called 3-pin kidney connectors) enabling control of the end device (prosthesis) movement in accordance with the range of 0-5 [V] adopted in prosthetics. At the same time, these connectors supply the device with power in accordance with the range of 6-8.4 [V] accepted in upper limb prosthetics. Aether MyoSense is provided without dome electrodes. Aether MyoSense should be used with compliant passive electrode domes, such as CoApt ControlSeal. The device is driven by the software version 1.0.3.
Published
2026-10-08
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
05905515340793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05905515340793059055153407935905515340793

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology/electromyographic sensor setA collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

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
05905515340618ZEUSA02L-SF0B2026-10-07
05905515340632ZEUSA02R-SF0B2026-10-07
05905515340717ZEUSA02L-MF0B2026-10-07
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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