TSA Device Description.pdf
The Cionic Neural Sleeve is bionic clothing that combines the diagnostic power of a gait lab with the therapeutic power of Functional Electrical Stimulation (FES) into a lightweight, durable (and stylish) garment that can be worn anywhere and work everywhere.
Cionic Neural Sleeve TM Can Assist With:
• Improved walking for individuals with:
− Multiple Sclerosis
− Cerebral Palsy
− Stroke
− Incomplete Spinal Cord Injury
− Traumatic Brain Injury, or
− Other neuromuscular diagnoses
• Exercise and muscle conditioning for individuals with leg weakness
through the Cionic app
Combines Function & Form
• First-of-its-kind Read + Write Neural Interface for measuring and activating
• Easy-to-don sleeve and software-steerable stimulation provide
Advanced Technology:
• Coordinated FES activation
quadriceps, hamstrings during gait
• Algorithms that continuously measure user movement and adapt to individual needs
The Cionic Neural Sleeve is an FDA
cleared Class II Medical device
FDA Clearance K213622
Rigorously Tested in Trials
94% of participants
90% of participants inversion during swing
9° average improvement to dorsi+inversion across all participants
Technical Specifications
Neural Sleeve
| Clonic Neural Sleeve NS-100 | |
|---|---|
| Classification | Internally powered, continuous operation with Type BF applied parts |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh |
| Controls | Single button |
| Indicators | Single LED indicator |
| Operating Modes | Exercise & Assist |
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive output channels and 15 virtual Negative output channels |
| Number of EMG (input) Channels | 8 |
| EMG Sampling Rate | 2kHz |
| EMG detection(Bipolar/Monopolar) | Bipolar |
| Waveform(e.g., pulsed monophasic,biphasic) | Pulsed Monophasic with hybrid stimulation |
| Regulated Current or Regulated Voltage | Regulated Current |
| Charging System | Medical Class II Power Adapter Input:100-240V~50/60HzOutput:5V2Ausing USB-C cable |
| Weight | Control unit(DC-100):145gSleeve(SL-100):S2230g,S4240g,S6250g |
| Dimensions[W×H×D] | Control unit(DC-100):137x53x24mmSleeve(SL-100)S252x61cm,S458x63cm,S669x68cm |
| Waveform | Pulsed Monophasic with hybrid stimulation |
| Shape | Rectangular |
| Maximum Output Voltage | 135V |
| Maximum Output Current | 100mA@500Ω,65mA@2kΩ,13mA@10kΩ |
| Current | 0 to 100mA at 5mA increments |
| Pulse Width | 100 to 400μs at 100μs increments |
| Frequency | 5-100Hz at 5Hz increments |
| Maximum Intensity | 24.6mA(rms) |
| Maximum Load | Maximum load:300Ω |
| Minimum Load | Minimum load:22kΩ |
| Sizes | 52,54,56 |
| Materials | Control Unit(DC-100):Injection Molded Plastic(medical grade polycarbonate(Makrolon))with encased electrical componentsSleeve(SL-100):84%Polyester16%LycraSleeve(SL-100) Sensors:Injection Molded Plastic(medical grade polycarbonate(Makrolon))with encased electrical components |
| Environmental Ranges | Transport and storage temperature:-4°Fto+140°F(-20℃to+45℃)Operating conditions temperature:41°Fto104°F(5°Cto40°C)Charging temperature:41°Fto104°F(5°Cto40°C)Relative humidity:10%to75%Operating humidity:15%to93%Shipping pressure:20kPa to106kPaOperating pressure:70kPa to106kPa |
CIONIC, Inc.
1606 Stockton St. Suite #1 San
fax: +1 (510) 426-7572