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510(k) Data Aggregation
K Number
K991590Device Name
C-LEG (3C100)
Manufacturer
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
Date Cleared
1999-07-08
(62 days)
Product Code
ISW
Regulation Number
890.3500Why did this record match?
Product Code :
ISW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fitting of lower limb prosthesis .
Highly mobile individuals and/or individuals who need stance stability .
Device Description
C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability.
The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of:
- Carbon Fiber Frame ●
- Hydraulics with Servo Motor ●
- Electronics .
- Distal Tube Clamp ●
- . Upper Joint
- Shin Tube Adapter
Components of the C-LEG (3C100) are the following:
- Electronic Knee Joint 3C87 ●
- 2R90 Tube Adapter or .
- Tube Adapter with Torsion Adapter 2R91 .
- Rotation Adapter 4R57 .
Accessories are the following:
• 757L17 Charging Device
- Power Unit ● 757L16
- Prosthetic Foot 1D10, 1D25, 1A30 .
- Foam Cover ● 3826
- . 4X70 Slider Software
- Extension Cable . 4X72
- 4X71 PC Interface .
- 4R302 Transportation Case ●
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