Aether Digital Platform

Primary DI
05904569152253
Brand
Aether Digital Platform
Company
AETHER BIOMEDICAL SP Z O O
Model
W-ADP
Device description
The W-ADP software is an online platform to monitor Zeus V1 hand, monitor the usage of the device for the purpose of the settings and includes module to remotely connect with the patient.
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NHFMonitor, Orthotic/Prosthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHFMonitor, Orthotic/ProstheticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05904569152253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904569152253059045691522535904569152253

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, powered-support, upper-limbAn assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
850705379
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05904569152291ZEUSA-01-L-T2023-03-24
05905515340014ZEUSA-01-R-T2023-03-19
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
00860013109806OPSB SensorBoston Brace International, Inc.NHF2025-02-21
05904569152260Aether Digital PlatformAETHER BIOMEDICAL SP Z O ONHF2023-10-31