TSA Device Description.pdf
TM
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:
TM Cionic Neural Sleeve 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)rechargeable7.4V1900mAh |
| 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~50/60HZ Output: 5V 2A using USB-C cable |
| Weight | Control unit(DC-100): 145g Sleeve(SL-100): S2 230g, S4 240g, S6 250g |
| Dimensions[WxHxD] | Control unit(DC-100) 137x53x24mm Sleeve(SL-100) S2 52x61cm, S4 58x63cm, S6 69x68cm |
| 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 | S2, S4, S6 |
| Materials | Control Unit(DC-100): Injection Molded Plastic (medical grade polycarbonate (Makrolon)) with encased electrical components Sleeve(SL-100): 84% Polyester 16% Lycra Sleeve(SL-100) Sensors: Injection Molded Plastic (medical grade polycarbonate (Makrolon)) with encased electrical components |
| Environmental Ranges | Transport and storage temperature: -4°F to +140°F (-20℃ to +45℃) Operating conditions temperature: 41°F to 104°F (5°C to 40°C) Charging temperature: 41°F to 104°F (5°C to 40°C) Relative humidity: 10% to 75% Operating humidity: 15% to 93% Shipping pressure: 20kPa to 106kPa Operating pressure: 70kPa to 106kPa |
CIONIC, Inc.
email: info@cionic.com
1500 Green Hills Rd. STE#109
tel: +1 (888) 237-1715
Scotts Valley, CA 95066
fax: +1 (510) 426-7572