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510(k) Data Aggregation
K Number
K220002Device Name
Dexus Prosthetics System (Model: MSL1, MSR1)
Manufacturer
Zhejiang Qiangnao Technology Co.,Ltd
Date Cleared
2022-09-09
(248 days)
Product Code
GXY, IQZ
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Qiangnao Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.
Device Description
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies the surface electromyography (sEMG) signal to realize the control of the upper limb prosthetic device. The collected EMG signals are processed through specific algorithms to achieve the delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.
The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.
The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.
The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.
The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:
- Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
- Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
- Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.
In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the hand.
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