HANDBOOK (V
4.0)
COMPLETE CONTROL SYSTEM GEN2
8
Accessories to the
Complete Control
System Gen2 include the following:
1.
Complete Controller
Fabrication Aid (1:1 scale disposable model for use in prosthesis fabrication)
2.
Prosthesis socket cut-out template for the
Complete Calibrate
button
3.
Complete Communicator
USB Bluetooth Dongle
4.
Complete ControlRoom
Gen2 User Interface Application
COMPATIBLE DEVICES
Electrodes
The
Complete Control
System Gen2 can be used with commercially available non-filtering, passive EMG
electrode contacts. Coapt recommends the use of stainless-steel electrode domes as contacts. The compatible
electrodes are shown below. Please contact a Coapt representative with any questions about compatible
electrodes.
PRODUCT INFORMATION
RELATED PRODUCT REGISTRATION
510(K)
Manufacturer:
Coapt, LLC
Product Name:
Dome Electrodes
Part Number(s):
D37C13T4L50
Proprietary Name:
Dome Electrode
Registered Establishment Number:
Coapt, LLC, 3010605876
Product Code and Regulation Number:
GXY, 882.1320
K190416
Manufacturer:
Liberating Technologies, Inc.
Product Name:
Small Dome Metal Electrodes
Part Number(s):
EL03
Proprietary Name:
Joint, Elbow, External Limb
Establishment Number:
Liberating Technologies, Inc., 1220851
Product Code and Regulation Number:
IRE, 890.3420
none
Manufacturer:
Motion Control, Inc.
Product Name:
Remote Electrode (Single)
Part Number(s):
1070001
Proprietary Name:
Electric Terminal Device; Motion Control Hand;
Motion Control Wrist; Procontrol 2
Registered Establishment Number:
Motion Control, Inc., 1723997
Product Code and Regulation Number:
IQZ, 890.3420
Proprietary Name:
NYElbow; Utah Arm
Registered Establishment Number:
Fillauer, LLC, 1022826
Product Code and Regulation Number:
IRE, 890.3420
none
Manufacturer:
RSLSteeper
Product Name:
Kit of 6 (High/Medium/Small)
Dome Metal Electrodes
Part Number(s):
NEL11, NEL12, NEL13
Proprietary Name: bebionic:
ELEC 60; Prosthesis
Registered Establishment Number:
Steeper Group LTD, 9612243
Product Code and Regulation Number:
IQZ, 890.3420
none
Manufacturer:
Touch Bionics
Product Name:
Remote Electrode kit
Part Number(s):
PL441012, PL069466,
PL06947, PL069468, PL069469
Proprietary Name:
Remote Electrode kit
Registered Establishment Number:
Touch Bionics, 3008018840
Product Code and Regulation Number:
IQZ, 890.3420
none
Skin irritation.
Use of non-biocompatible materials (or materials to which the user is allergic)
for electrode contacts may cause skin rash or skin irritation. Ensure electrode contacts are
made of biocompatible material and do not cause an allergic reaction.