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510(k) Data Aggregation
K Number
K123795Device Name
AXON-BUS PROSTHETIC SYSTEM
Manufacturer
OTTO BOCK AUSTRIA
Date Cleared
2014-06-03
(540 days)
Product Code
GXY, IQZ
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
OTTO BOCK AUSTRIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Device Description
The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings. The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. The prosthesis is intended exclusively for use on one patient. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course.
System Components:
- Michelangelo Hand (terminal device)
- AxonFlexion Adapter (passive flexion)
- AxonRotation Adapter (passive rotation)
- AxonArm (passive elbow joint with mechanical and/or electrical lock)
- AxonEnergy Integral (battery)
- AxonCharge (charger)
- AxonMaster (control unit)
- Electrode (detecting EMG Input signals)
- AxonSoft (adjustment software)
- AxonSkin (prosthetic glove)
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