(140 days)
Not Found
No
The document does not explicitly mention the use of AI, DNN, or ML models within the device's description or functionality. The device uses embedded sensors and a control unit to generate stimulation for muscle activation and exercise, which is typically a rule-based or algorithmic control system rather than an AI model.
Yes
The device's intended use clearly states it is for therapeutic purposes, including assisting with foot drop and muscle weakness, facilitating muscle re-education, preventing disuse atrophy, maintaining joint range of motion, increasing local blood flow, and relaxing muscle spasms.
No
The device is described as providing electrical stimulation to muscles for purposes such as improving gait, facilitating muscle re-education, preventing disuse atrophy, maintaining joint range of motion, increasing local blood flow, and relaxing muscle spasms. While it has embedded sensors to measure limb movement and muscle activity (biofeedback), its primary function is therapeutic stimulation rather than diagnosis.
No
The device description clearly states it is composed of a "body-worn legging, a battery-powered electronic controller and a mobile application." It includes physical components like the sleeve with embedded sensors, a control and stimulation unit, and electrode pads, all of which are hardware. The modifications mentioned are also hardware/mechanical changes.
No.
The device is a powered muscle stimulator and biofeedback device that applies electrical stimulation and measures limb movement and muscle activity; it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-200 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Relaxation of muscle spasm
As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
Product codes
GZI, IPF, HCC
Device Description
Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.
The Cionic Neural Sleeve NS-200 system sales carton consists of the following components:
- SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large.
- DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").
- Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required.
- Adhesive, electrically conductive and replaceable electrode pads.
- Electrode cover sheets.
- Instructions for Use documents.
Components are available as accessories to the Cionic Neural Sleeve NS-200 system:
- Replacement electrode pads.
The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users.
The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.
The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200:
- Simplified Sleeve Electronics
By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users. - Enhanced Control Unit Grip
The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love. - More Secure Fit, All Day Comfort
Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.
New Functionality in NS-200
When compared to the primary predicate device, the Cionic NS-100 (K221823), while maintaining the same hardware architecture, the NS-200 introduces advanced biofeedback capabilities through software enhancements that leverage the existing surface electromyography (sEMG) functionality. This biofeedback implementation is delivered through two distinct training modes within the existing Exercise Programs:
- Visual Biofeedback Mode
This mode operates without electrical stimulation, providing real-time visual feedback through the mobile application interface. The user's muscle activation levels are displayed as dynamic intensity bars on the smartphone screen, allowing the user to visualize and modulate the muscle recruitment patterns. - Muscle Activated Stimulation Mode
This mode creates a closed loop feedback system where the user's voluntary muscle contractions, detected through sEMG, trigger electrical stimulation when reaching specific thresholds. The stimulation trigger is set at 20% of the maximum activation level recorded during the EMG calibration step.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb (affected leg), ankle, foot, knee, shin (Tibialis Anterior), Quadriceps, Calf (Gastrocnemius), Hamstrings
Indicated Patient Age Range
Adult individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Performance Testing:
The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve NS-200 performs as intended and is substantially equivalent to both predicate devices.
- Stimulation Output Waveforms
- Stimulation Output Specifications
- Stimulation Virtual Output Channels
- Stimulation Output Channel Isolation
- Hybrid Stimulation
- Stimulation Electrodes Short and/or Open Detection
- Wireless Coexistence
- Electrical Safety according to IEC 60601-1; IEC 60601-1-11
- Muscle and Nerve Stimulators according to IEC 60601-2-10
- Electromagnetic compatibility according to IEC 60601-1-2
- Software validation according to IEC 62304
The following non-clinical performance tests were leveraged from the predicate device submission because the addition of biofeedback and the minor software modifications did not affect the following testing areas for the subject device:
- Usability according to IEC 62366; IEC 60601-1-6 (Summative Evaluation)
Summary of Literature Clinical Data:
The Cionic Neural Sleeve NS-200 stimulates dorsiflexors and evertors of the leg to provide foot eversion. There is no new intended use when compared to the intended use of the primary predicate device, NS-100 (K221823). The new indication of providing foot eversion is supported by the article titled "Augmenting Gait in a Population Exhibiting Foot Drop with Adaptive Functional Electrical Stimulation" (https://www.medrxiv.org/content/10.1101/2022.04.27.22273623v2.full).
Conclusion:
The Cionic Neural Sleeve NS-200 has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware. Based on the result of the nonclinical testing, Cionic concludes that the device is substantially equivalent to both predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neural Sleeve NS-100 K221823, STIWELL med4 K080950
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - Cionic Neural Sleeve (NS-200)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 2, 2025
CIONIC Inc.
Mihai Ionescu
EVP Hardware and Manufacturing
1500 Green Hills Road Suite 109
Scotts Valley, California 95066
Re: K243828
Trade/Device Name: Cionic Neural Sleeve (NS-200)
Regulation Number: 21 CFR 882.5810
Regulation Name: External Functional Neuromuscular Stimulator
Regulatory Class: Class II
Product Code: GZI, IPF, HCC
Dated: March 31, 2025
Received: March 31, 2025
Dear Mihai Ionescu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K243828 - Mihai Ionescu Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243828 - Mihai Ionescu Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lauren E. Woodard -S
for Amber Ballard, PhD
Assistant Director
DHT5B: Division of Neuromodulation and Physical Medicine Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K243828
Device Name
Cionic Neural Sleeve NS-200
Indications for Use (Describe)
The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-200 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Relaxation of muscle spasm
As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(K) Summary
I SUBMITTER
Cionic, Inc.
1500 Green Hills Road
Suite 109
Scotts Valley, CA 950-66
Contact Person: Mihai Ionescu
Email: mihai@cionic.com
Phone Number: (831) 824-4051
Date Prepared: December 10, 2024
II PROPOSED DEVICE
Trade / Device Name: Neural Sleeve NS-200
Manufacturer: Cionic Inc.
Regulation Number: 21 CFR 882.5810
Regulation Name: External Functional Neuromuscular Stimulator
Regulatory Class: Class II
Product Code: GZI, IPF, HCC
510(k) Number: K243828
III PREDICATE DEVICES
Primary Predicate Device: Neural Sleeve NS-100
Manufacturer: Cionic Inc.
510(k) Number: K221823
Secondary Predicate Device: STIWELL med4
Manufacturer: Otto Bock Healthcare Product GmbH
510(k) Number: K080950
IV DEVICE DESCRIPTION
General Information
Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.
Page 6
The Cionic Neural Sleeve NS-200 system sales carton consists of the following components:
-
SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large.
-
DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").
-
Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required.
-
Adhesive, electrically conductive and replaceable electrode pads.
-
Electrode cover sheets.
-
Instructions for Use documents.
Components are available as accessories to the Cionic Neural Sleeve NS-200 system:
- Replacement electrode pads.
The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users.
The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.
The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200:
-
Simplified Sleeve Electronics
By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users. -
Enhanced Control Unit Grip
The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love. -
More Secure Fit, All Day Comfort
Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.
New Functionality in NS-200
When compared to the primary predicate device, the Cionic NS-100 (K221823), while maintaining the same hardware architecture, the NS-200 introduces advanced biofeedback
Page 7
capabilities through software enhancements that leverage the existing surface electromyography (sEMG) functionality. This biofeedback implementation is delivered through two distinct training modes within the existing Exercise Programs:
-
Visual Biofeedback Mode
This mode operates without electrical stimulation, providing real-time visual feedback through the mobile application interface. The user's muscle activation levels are displayed as dynamic intensity bars on the smartphone screen, allowing the user to visualize and modulate the muscle recruitment patterns. -
Muscle Activated Stimulation Mode
This mode creates a closed loop feedback system where the user's voluntary muscle contractions, detected through sEMG, trigger electrical stimulation when reaching specific thresholds. The stimulation trigger is set at 20% of the maximum activation level recorded during the EMG calibration step.
V INDICATIONS FOR USE
The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-200 may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Relaxation of muscle spasm
As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
VI COMPARISON OF INTENDED USE
Table 1. COMPARISON OF INDICATIONS FOR USE
| Characteristic | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE |
Page 8
| 510(k) Number | K243828 | K221823 | K080950 |
|---|---|---|---|
| Device Name, Model | Neural Sleeve NS-200 | Neural Sleeve NS-100 | STIWELL med4 |
| Manufacturer | Cionic Inc. | Cionic Inc. | Otto Bock Healthcare Product GmbH |
| Regulation | 21 CFR 882.5810 | 21 CFR 882.5810 | 21 CFR 890.5850 |
| Product codes | GZI, IPF, HCC | GZI, IPF | IPF, GZJ, HCC, GZI, KPI |
| Intended Use / Indications for Use | The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. |
The Cionic Neural Sleeve NS-200 may also:
• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow
As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
• Relaxation of muscle spasm
As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:
• Biofeedback, relaxation and muscle re-education purposes | The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
The Cionic Neural Sleeve NS-100 may also:
- Facilitate muscle re-education
- Precent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow | The STIWELL med4 is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator STIWELL med4 is indicated for the following conditions:
- Relaxation of muscle spasm
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term) intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator, the STIWELL med4 is indicated for the following conditions:
- Helps relearn voluntary motor |
Page 9
functions of the extremities
Note: Same as the secondary predicate device (STIWELL med4, K080950), Cionic Neural Sleeve NS-200 utilizes EMG biofeedback to achieve muscle relaxation and re-education.
VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Table 2. Functional Electrical Stimulation Modes
| Characteristic | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | SE Comparison |
|---|---|---|---|---|
| 510(k) Number | K243828 | K221823 | K080950 | |
| Device Name, Model | NS-200 | NS-100 | STIWELL med4 | |
| Manufacturer | Cionic Inc. | Cionic Inc. | Otto Bock Healthcare Product GmbH | |
| Regulation | 21 CFR 882.5810 | 21 CFR 882.5810 | 21 CFR 890.5850 | |
| Product codes | GZI, IPF, HCC | GZI, IPF | IPF, GZJ, HCC, GZI, KPI | |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Battery Pack Li-Ion 11.1V | The subject device's battery is identical to the battery of the primary predicate device and is very similar to the battery of the secondary predicate device. All three devices meet electrical safety standards. The battery of the proposed device meets IEC 62133-2, Edition 1.0, 2017-02 (also an FDA-recognized standard). Differences are considered minor with no impact on safety and effectiveness since all three devices adhere to recognized/consensus electrical/battery safety standards. |
| Method of Line Current Isolation | Medical Class II Power Adapter | |||
| Input: 100-240V 50/60Hz | ||||
| Output: 5V 2A using USB-C cable | not publicly available | Medical Class II Power Adapter – Mascot (12.6VDC-15.1W) | Differences when compared to the secondary predicate device are considered minor with no impact on safety and effectiveness | |
| Number of Output Modes | 1 mode: Monophasic with hybrid stimulation | 1 mode: Monophasic with hybrid stimulation | 1 | The subject device is identical to the primary predicate device. |
Page 10
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 3 | The subject device is identical to the primary predicate device. Compared to the secondary predicate device, the subject device includes fewer physical stimulation channels. However, it achieves the same therapeutic effects and delivers substantially equivalent stimulation by incorporating a 24-channel high-voltage multiplexer (MUX). This MUX functions as an electronic switch that time-shares a single stimulation output across multiple electrodes in rapid succession. Differences are considered minor with no impact on safety and effectiveness. |
|---|---|---|---|---|
| Stimulated Muscles | Shin (Tibialis Anterior) | |||
| Quadriceps | ||||
| Calf (Gastrocnemius) | ||||
| Hamstrings | not publicly available | FES 1 (Grasp/Release): Wrist extensors, Finger flexors, Thumb flexor |
FES 2 (Grasp/Release [EMG]): Wrist extensors, Finger flexors, Thumb flexor
FES 3 (Open/Close): Finger/thumb extensors, Finger flexors, Thumb flexor
FES 4 (Open/Close [EMG]): Finger/thumb extensors, Finger flexors, Thumb flexor | When compared to the secondary predicate device, although the subject device targets a different set of muscles, both utilize functional electrical stimulation to improve body movements. |
| Number of EMG (input) Channels | 8 | Not publicly available | FES 1 (Grasp/Release): 0
FES 2 (Grasp/Release [EMG]): 1
FES 3 (Open/Close): 0
FES 4 (Open/Close [EMG]): 1 | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
Differences when compared to the secondary predicate device are considered minor with no impact on safety and effectiveness
The subject device is identical to the primary predicate device.
Compared to the secondary predicate device, the subject device includes fewer physical stimulation channels. However, it achieves the same therapeutic effects and delivers substantially equivalent stimulation by incorporating a 24-channel high-voltage multiplexer (MUX). This MUX functions as an electronic switch that time-shares a single stimulation output across multiple electrodes in rapid succession. Differences are considered minor with no impact on safety and effectiveness.
Page 11
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 3 | Compared to the secondary predicate device, the subject device includes fewer physical stimulation channels. However, it achieves the same therapeutic effects and delivers substantially equivalent stimulation by incorporating a 24-channel high-voltage multiplexer (MUX). This MUX functions as an electronic switch that time-shares a single stimulation output across multiple electrodes in rapid succession. Differences are considered minor with no impact on safety and effectiveness. |
|---|---|---|---|---|
| Stimulated Muscles | Shin (Tibialis Anterior) | |||
| Quadriceps | ||||
| Calf (Gastrocnemius) | ||||
| Hamstrings | not publicly available | FES 1 (Grasp/Release): Wrist extensors, Finger flexors, Thumb flexor |
FES 2 (Grasp/Release [EMG]): Wrist extensors, Finger flexors, Thumb flexor
FES 3 (Open/Close): Finger/thumb extensors, Finger flexors, Thumb flexor
FES 4 (Open/Close [EMG]): Finger/thumb extensors, Finger flexors, Thumb flexor | When compared to the secondary predicate device, although the subject device targets a different set of muscles, both utilize functional electrical stimulation to improve body movements. |
| Number of EMG (input) Channels | 8 | Not publicly available | FES 1 (Grasp/Release): 0
FES 2 (Grasp/Release [EMG]): 1
FES 3 (Open/Close): 0
FES 4 (Open/Close [EMG]): 1 | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
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| EMG Sensitivity | 0.0298 μV | Not publicly available | FES 1 (Grasp/Release): N/A
FES 2 (Grasp/Release [EMG]): 1 μV
FES 3 (Open/Close): 0
FES 4 (Open/Close [EMG]): 1 μV | When compared to the FES 2 and FES 4 modes of the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
|---|---|---|---|---|
| EMG Sampling Rate | 2kHz | Not publicly available | FES 1 (Grasp/Release): N/A
FES 2 (Grasp/Release [EMG]): 3kHz
FES 3 (Open/Close): N/A
FES 4 (Open/Close [EMG]): 3kHz | When compared to the FES 2 and FES 4 modes of the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
| EMG detection (bipolar/monopolar) | Bipolar | Bipolar | FES 1 (Grasp/Release): N/A
FES 2 (Grasp/Release [EMG]): bipolar
FES 3 (Open/Close): N/A
FES 4 (Open/Close [EMG]): bipolar | Identical to the primary predicate device and the FES 2 and FES 4 modes of the secondary predicate device. |
| EMG range (μV) | +/-2.5*10⁶ μV | Not publicly available | FES 1 (Grasp/Release): N/A
FES 2 (Grasp/Release [EMG]): 1-2000 μV
FES 3 (Open/Close): N/A
FES 4 (Open/Close [EMG]): 1-2000 μV | When compared to the FES 2 and FES 4 modes of the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
| EMG bandwidth | 10-500 Hz | Not publicly available | FES 1 (Grasp/Release): N/A
FES 2 (Grasp/Release [EMG]): 70-480 Hz
FES 3 (Open/Close): N/A | When compared to the FES 2 and FES 4 modes of the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
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| FES 4 (Open/Close [EMG]): 70-480 Hz | ||||
|---|---|---|---|---|
| EMG signal processing (e.g. RMS) | RMS (Root Mean Square) | Not publicly available | FES 1 (Grasp/Release): N/A | |
| FES 2 (Grasp/Release [EMG]): AVR (Average Rectified Value) | ||||
| FES 3 (Open/Close): N/A | ||||
| FES 4 (Open/Close [EMG]): AVR | When compared to the FES 2 and FES 4 modes of the secondary predicate device, differences in EMG signal processing does not lead to questions of safety and effectiveness because both RMS and AVR can be used to quantify the amplitude or magnitude of the EMG signal, providing an estimate of muscle activity | |||
| Synchronous or Alternating | Alternating | Not publicly available | Alternating | Identical to the secondary predicate device |
| Method of Channel Isolation | The virtual output channels are multiplexed through a 24-channel high voltage analog switch with channel isolation of -33 dB (typical), Switch crosstalk of -70 dB (typical) and switch-off leakage current of 1 μA typical per switch | Not publicly available | Transformer, Inductive couplers | When compared to the secondary predicate device, both are using high voltage FET (field-effect transistor) switches. The secondary predicate device uses a different method of isolation, but both methods achieve the same result. This was based on the results of the channel isolation bench test, and the IC manufacturer datasheet |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Regulated Current | Identical to both predicate devices |
| Software/Firmware Microprocessor Control? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Automatic Overload Trip, No-Load Trip, Shut Off? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Patient Override Control? | Yes (Stop Button) | Not publicly available | Yes (Stop Button) | Identical to the secondary predicate device |
| Indicator Display On/Off Status? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Indicator Display: Low Batt? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Indicator Display: Voltage Current Level? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
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| Timer Range (minutes) | Gait mode: (dependent on length and speed of stride) 0-5sec max stimulation duration (user and technician selectable).
Exercise mode: 1-60 minutes.
EMG triggered stimulation: 1-60 minutes | Not publicly available | 15-60 min | When compared to the secondary predicate device, differences in timer range are considered minor since overall intended uses are the same and ultimately achieve the same result i.e., muscle stimulation |
|---|---|---|---|---|
| Compliance with voluntary Standards? | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | Not publicly available | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | Identical to the secondary predicate device |
| Compliance with 21 CFR 898 | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Weight | Control Unit (DC-200) 145g
Sleeve (SL-200 Left and Right)
X-Small (S0) 220g
Small (S2) 230g
Medium (S4) 240g
Large (S6) 250g | DC-100 145 g
SL-100 Medium 240g
SL-100 Small 230g | 440 g | The subject device is identical to the primary predicate device in the weight of the Control Unit, Medium Sleeve, and Small Sleeve. The subject device's sleeve is available in X-small and Large. This difference is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences are insignificant and do not raise any issues related to safety and effectiveness |
| Dimensions [W x H x D] | Control Unit (DC-200) 136 x 54 x 24 mm
Sleeve (SL-200 Left and Right)
X-Small (S0) 500 x 600 mm
Small (S2) 520 x 610 mm
Medium (S4) 580 x 630 mm
Large (S6) 690 x 680 mm | DC-100 137 x 53 x 24 mm
SL-100 Medium 613 x 602 mm
SL-100 Small 596 x 560 mm | Device: 175 x 95 x 30 mm | The subject device's dimension is very similar when compared to the primary predicate device. This difference in dimension is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences are insignificant and do not raise any issues related to safety and effectiveness |
| Waveform (e.g., pulsed monophasic, biphasic) | Monophasic with hybrid stimulation | Not publicly available | Biphasic Symmetrical | Although the stimulation waveform is different from that of the secondary predicate, the subject device has passed IEC 60601-1 and IEC 60601-2-10, |
Page 15
| so this difference should not affect safety and effectiveness | ||||
|---|---|---|---|---|
| Shape | Rectangular | Not publicly available | Rectangular | Identical to the secondary predicate |
| Maximum Output Voltage (+/- 10%) [V] | 50V @ 500 Ω | |||
| 125V @ 2 kΩ | ||||
| 130V @ 10 kΩ | not publicly available | 50V @ 500 Ω | ||
| 115V @ 2 kΩ | ||||
| N/A @ 10 kΩ | Differences between the subject and the secondary predicate devices have no impact on safety and effectiveness since all three devices adhere to recognized consensus and standards and the values are similar within range | |||
| Maximum Output Current (+/- 10%) [mA] | 100 mA @ 500 Ω | |||
| 62.5 mA @ 2 kΩ | ||||
| 13 mA @ 10 kΩ |
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
58 mA @ 2 kΩ
N/A @ 10 kΩ
Irms: N/A | Differences between the subject and the predicate devices are considered minor and have no impact on safety and effectiveness since all three devices adhere to recognized consensus and standards and the values are similar within range |
| Pulse width | 100, 200, 300, and 400μs
Default 300μs | not publicly available | 50 to 400 μs | very similar when compared to the secondary predicate device. Although the pulse width ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
| Frequency [Hz] | 5 – 125 Hz in 5Hz increment
Default 35Hz | not publicly available | 1 – 140 Hz
Default 35 Hz | very similar when compared to the secondary predicate device. Although the frequency ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
| Net Charge [µC/pulse] (500Ω) | 0 μC using Hybrid Stimulation | not publicly available | 0 µC Same positive and negative impulse | very similar when compared to the secondary predicate device. Although the method used to achieve 0 μC is different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness |
| Maximum Phase Charge[µC] @ 500Ω | 40 [μC] @ 500Ω
400 μs * 100 mA = 40 μC | not publicly available | 40 [μC] @ 500Ω | Identical to the secondary predicate device |
Page 16
| Maximum Current (RMS) Density [mA/cm²] | 1.24 mA/cm²]
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz electrode area of 19.8cm² | 0.98 mA/cm²
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz electrode area of 25cm² | 12.5 mA/cm² | The Maximum Current Density of the subject device is very similar when compared to that of the primary predicate device. Differences are considered minor and have no impact on safety and effectiveness since all three devices adhere to recognized consensus |
|---|---|---|---|---|
| Maximum Power Density [mW/cm²] | 12mW/cm²
(500 Ω, Irms=24.6 mA, electrode area of 19.8 cm²) | 12mW/cm²
(500 Ω, Irms=24.6 mA, electrode area of 25 cm²) | 7.9mW/cm2 | The subject device is identical to the primary predicate device and within the range of the secondary predicate device |
| ON Time (seconds) | Gait Mode: Maximum 5 seconds after triggering event
Exercise Mode: Maximum 20 seconds after triggering event.
Interleaved Afferent Stimulation: Pulse bursts are triggered at the start of gait mode or exercise mode and terminated at the end of the mode. Stimulation pulses of the afferent pulse train are interleaved with pulses from the FES pulse trains of gait and exercise mode. | not publicly available | 1-20 sec | The subject device and the secondary predicate device have equivalent stimulation ON times in Exercise Mode (up 20 seconds). When compared to the secondary predicate device, the subject device includes an additional feature—Interleaved Afferent Stimulation—where low-frequency pulse bursts are triggered at the start of each mode and terminate at the end of the mode. These afferent pulses are interleaved with the standard FES pulses and do not extend the total duration of stimulation. This implementation does not increase total stimulation time or intensity and remains within known safe and effective use parameters for neuromuscular stimulation. Therefore, this difference does not raise any issues related to safety or effectiveness since all three devices adhere to recognized/consensus electrical safety standards and are similar within the range |
| OFF Time (seconds) | Exercise Mode: maximum 60 seconds
Gait Mode: not limited | not publicly available | 1-30 sec | The subject device is similar to the secondary predicate device. Differences have no impact on safety and effectiveness since all three devices adhere to recognized/consensus electrical safety standards and are similar within the range |
Note: The FES functionality within the NS-200 and NS-100 can be subdivided into two broad categories:
- Gait Mode: Here, sEMG is used solely for monitoring the user's muscle activities but does not drive or trigger stimulation.
- Exercise Mode: In these protocols, sEMG has a closed-loop control role, where the user's muscle activation signals can directly impact stimulation timing and intensity. This approach synchronizes stimulation delivery with voluntary muscle activation to enhance neuromuscular reeducation and functional performance.
Page 17
Table 3. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Powered Muscle Stimulator
| Characteristic | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | SE Comparison |
|---|---|---|---|---|
| 510(k) Number | K243828 | K221823 | K080950 | |
| Device Name, Model | NS-200 | NS-100 | STIWELL med4 | |
| Manufacturer | Cionic Inc. | Cionic Inc. | Otto Bock Healthcare Product GmbH | |
| Regulation | 21 CFR 882.5810 | 21 CFR 882.5810 | 21 CFR 890.5850 | |
| Product codes | GZI, IPF, HCC | GZI, IPF | IPF, GZJ, HCC, GZI, KPI | |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Battery Pack Li-Ion 11.1V | The subject device's battery is identical to the battery of the primary predicate device and is very similar to the battery of the secondary predicate device. |
All three devices meet electrical safety standards. The battery of the proposed device meets IEC 62133-2, Edition 1.0, 2017-02 (also an FDA-recognized standard). Differences are considered minor with no impact on safety and effectiveness since all three devices adhere to recognized/consensus electrical/battery safety standards. |
| Method of Line Current Isolation | Medical Class II Power Adapter
Input: 100-240V 50/60Hz
Output: 5V 2A using SB-C cable | not publicly available | Medical Class II Power Adapter – Mascot (12.6VDC-15.1W) | Differences when compared to the secondary predicate device are considered minor with no impact on safety and effectiveness |
| Number of Output Modes | 1 mode: Monophasic with hybrid stimulation | 1 mode: Monophasic with hybrid stimulation | 1 | The subject device is identical to the primary predicate device.
Differences when compared to the secondary predicate device are considered minor |
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| with no impact on safety and effectiveness | ||||
|---|---|---|---|---|
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 4 | The subject device is identical to the primary predicate device. |
Compared to the secondary predicate device, the subject device includes fewer physical stimulation channels. However, it achieves the same therapeutic effects and delivers equivalent stimulation parameters by incorporating a 24-channel high-voltage multiplexer (MUX). This MUX functions as an electronic switch that time-shares a single stimulation output across multiple electrodes in rapid succession.
Differences are considered minor with no impact on safety and effectiveness. |
| Synchronous or Alternating | Alternating | Not publicly available | Alternating | Identical to the secondary predicate device |
| Method of Channel Isolation | The virtual output channels are multiplexed through a 24-channel high voltage analog switch with channel isolation of -33 dB (typical), Switch crosstalk of -70 dB (typical) and switch-off leakage current of 1 μA typical per switch | Not publicly available | Transformer, Inductive couplers | Both the subject and the secondary predicate devices are using high voltage FET switches. The secondary predicate device uses a different method of isolation, but both methods achieve the same result. This was based on the results of the channel isolation bench test, and the IC manufacturer datasheet. |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Regulated Current | Identical to both predicate devices |
| Software/Firmware Microprocessor Control? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Automatic Overload Trip, No-Load Trip, Shut Off? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Patient Override Control? | Yes (Stop Button) | Not publicly available | Yes (Stop Button) | Identical to the secondary predicate device |
| Indicator Display On/Off Status? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
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| Indicator Display: Low Batt? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
|---|---|---|---|---|
| Indicator Display: Voltage Current Level? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Timer Range (minutes) | Exercises 1-60 minutes | Not publicly available | 2-120 min | Differences between the subject and the secondary predicate devices in timer range are considered minor since overall intended uses are the same and ultimately achieve the same result i.e., muscle stimulation |
| Compliance with voluntary Standards? | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-10 | Not publicly available | IEC 60601-1 | ||
| IEC 60601-1-2 | ||||
| IEC 60601-2-10 | Identical to the secondary predicate device | |||
| Compliance with 21 CFR 898 | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Weight | Control Unit (DC-200) 145g |
Sleeve (SL-200 Left and Right)
X-Small (S0) 220g
Small (S2) 230g
Medium (S4) 240g
Large (S6) 250g | DC-100 145 g
SL-100 Medium 240g
SL-100 Small 230g | 440 g | The subject device is identical to the primary predicate device in the weight of the Control Unit, Medium Sleeve, and Small Sleeve. The subject device's sleeve has more options in size (i.e., X-small and Large). This difference is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences are insignificant and do not raise any issues related to safety and effectiveness |
| Dimensions [W x H x D] | Control Unit (DC-200) 136 x 54 x 24 mm
Sleeve (SL-200 Left and Right)
X-Small (S0) 500 x 600 mm
Small (S2) 520 x 610 mm
Medium (S4) 580 x 630 mm
Large (S6) 690 x 680 mm | DC-100 137 x 53 x 24 mm
SL-100 Medium 613 x 602 mm
SL-100 Small 596 x 560 mm | Device: 175 x 95 x 30 mm | The subject device's dimension is very similar when compared to the primary predicate device. This difference in dimension is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences are insignificant and do not raise any issues |
Page 20
| related to safety and effectiveness | ||||
|---|---|---|---|---|
| Waveform (e.g., pulsed monophasic, biphasic) | Monophasic with hybrid stimulation | Not publicly available | Biphasic Symmetrical | Although the stimulation waveform of the subject device is different from that of the secondary predicate, the subject device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness |
| Shape | Rectangular | Not publicly available | Rectangular | Identical to the secondary predicate device |
| Maximum Output Voltage (+/- 10%) [V] | 50V @ 500 Ω | |||
| 125V @ 2 kΩ | ||||
| 130V @ 10 kΩ | Not publicly available | 50V @ 500 Ω | ||
| 115V @ 2 kΩ | ||||
| N/A @ 10 kΩ | Differences between the subject and the secondary predicate devices are considered minor and have no impact on safety and effectiveness since they adhere to recognized consensus and standards and the values are similar within range | |||
| Maximum Output Current (+/- 10%) [mA] | 100 mA @ 500 Ω | |||
| 62.5 mA @ 2 kΩ | ||||
| 13 mA @ 10 kΩ |
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
58 mA @ 2 kΩ
N/A @ 10 kΩ
Irms N/A | The subject device is very similar to the predicate devices. Differences are considered minor and have no impact on safety and effectiveness since all three devices adhere to recognized consensus and standards and the values are similar within range |
| Pulse width | 100, 200, 300, and 400μs
Default 300μs | Not publicly available | 50 to 400 μs | Very similar when compared to the secondary predicate. Although the pulse width ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
| Frequency [Hz] | 5 – 125 Hz in 5Hz increment
Default 35Hz | Not publicly available | 1 – 140 Hz | Very similar when compared to the secondary predicate. Although the frequency ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
Page 21
| related to safety and effectiveness | ||||
|---|---|---|---|---|
| Waveform (e.g., pulsed monophasic, biphasic) | Monophasic with hybrid stimulation | Not publicly available | Biphasic Symmetrical | Although the stimulation waveform of the subject device is different from that of the secondary predicate, the subject device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness |
| Shape | Rectangular | Not publicly available | Rectangular | Identical to the secondary predicate device |
| Maximum Output Voltage (+/- 10%) [V] | 50V @ 500 Ω | |||
| 125V @ 2 kΩ | ||||
| 130V @ 10 kΩ | Not publicly available | 50V @ 500 Ω | ||
| 115V @ 2 kΩ | ||||
| N/A @ 10 kΩ | Differences between the subject and the secondary predicate devices are considered minor and have no impact on safety and effectiveness since they adhere to recognized consensus and standards and the values are similar within range | |||
| Maximum Output Current (+/- 10%) [mA] | 100 mA @ 500 Ω | |||
| 62.5 mA @ 2 kΩ | ||||
| 13 mA @ 10 kΩ |
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz | 100 mA @ 500 Ω
58 mA @ 2 kΩ
N/A @ 10 kΩ
Irms: N/A | The subject device is very similar to the predicate devices. Differences are considered minor and have no impact on safety and effectiveness since all three devices adhere to recognized consensus and standards and the values are similar within range |
| Pulse width | 100, 200, 300, and 400μs
Default 300μs | Not publicly available | 50 to 400 μs | Very similar when compared to the secondary predicate. Although the pulse width ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
| Frequency [Hz] | 5 – 125 Hz in 5Hz increment
Default 35Hz | Not publicly available | 1 – 140 Hz | Very similar when compared to the secondary predicate. Although the frequency ranges are different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness. |
| Net Charge [µC/pulse] (500Ω) | 0 μC using Hybrid Stimulation | Not publicly available | 0 µC Same positive and negative impulse | The subject device is very similar when compared to the secondary predicate. Although the method used to achieve 0 μC is different from that of the secondary predicate, the proposed device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness |
| Maximum Phase Charge[µC] @ 500Ω | 40 [μC] @ 500Ω
400 μs * 100 mA = 40 μC | Not publicly available | 40 [μC] @ 500Ω | Identical to the secondary predicate device |
| Maximum Current (RMS) Density [mA/cm²] | 1.24 mA/cm²]
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz electrode area of 19.8cm² | 0.98 mA/cm²
Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 μs 125 Hz electrode area of 25cm² | 12.5 mA/cm² | The Maximum Current Density of the subject device is very similar when compared to that of the primary predicate device. Differences are considered minor and have no impact on safety and effectiveness since all three devices adhere to recognized consensus |
| Maximum Power Density [mW/cm²] | 12mW/cm²
(500 Ω, Irms=24.6 mA, electrode area of 19.8 cm²) | 12mW/cm²
(500 Ω, Irms=24.6 mA, electrode area of 25 cm²) | 7.9mW/cm2 | The subject device is identical to the primary predicate device and within the range of the secondary predicate device |
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| ON Time (seconds) | Exercise Mode: Maximum 20 seconds after triggering event.
Interleaved Afferent Stimulation: Pulse bursts are triggered at the start of exercise mode and terminated at the end of the mode. Stimulation pulses of the afferent pulse train are interleaved with pulses from the stimulation pulse trains of exercise mode. | Not publicly available | 1-20 sec | The subject device and the secondary predicate device have equivalent stimulation ON times Exercise Mode. The subject device includes an additional feature—Interleaved Afferent Stimulation—where low-frequency pulse bursts are triggered at the start of each mode and terminate at the end of the mode. These afferent pulses are interleaved with the standard FES pulses and do not extend the total duration of stimulation. This implementation does not increase total stimulation time or intensity and remains within known safe and effective use parameters for neuromuscular stimulation. Therefore, this difference does not raise any issues related to safety or effectiveness. |
|---|---|---|---|---|
| OFF Time (seconds) | Exercise Mode: maximum 60 seconds | Not publicly available | 1-50 sec | The subject device is very similar to the secondary predicate device. Differences are considered minor and have no impact on safety and effectiveness since they all adhere to recognized/consensus electrical safety standards and are similar within the range |
Note: For the NS-200 and NS-100 devices, the sEMG functionality is not active in Powered Muscle Stimulator mode
Table 4. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Biofeedback
| Characteristic | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | SE Comparison |
|---|---|---|---|---|
| 510(k) Number | K243828 | K221823 | K080950 | |
| Device Name, Model | NS-200 | NS-100 | STIWELL med4 | |
| Manufacturer | Cionic Inc. | Cionic Inc. | Otto Bock Healthcare Product GmbH | |
| Regulation | 21 CFR 882.5810 | 21 CFR 882.5810 | 21 CFR 890.5850 | |
| Product codes | GZI, IPF, HCC | GZI, IPF | IPF, GZJ, HCC, GZI, KPI | |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Battery Pack Li-Ion 11.1V | The subject device's battery is identical to the battery of the primary predicate device and is very similar to the battery of the secondary predicate device. |
All three devices meet electrical safety standards. The battery of the proposed device meets IEC 62133-2, Edition 1.0, 2017-02 (also an FDA-recognized standard). Differences are considered minor with no impact on safety and effectiveness since all three devices adhere to recognized/consensus electrical/battery safety standards. |
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| Method of Line Current Isolation | Medical Class II Power Adapter
Input: 100-240V 50/60Hz
Output: 5V 2A using USB-C cable | not publicly available | Medical Class II Power Adapter – Mascot (12.6VDC-15.1W) | Differences when compared to the secondary predicate device are considered minor with no impact on safety and effectiveness since all three devices adhere to recognized/consensus electrical safety standards and all devices are similar within range |
|---|---|---|---|---|
| Number of Output Modes | 1 mode: Monophasic with hybrid stimulation | 1 mode: Monophasic with hybrid stimulation | 1 | The subject device is identical to the primary predicate device. Differences when compared to the secondary predicate device are considered minor with no impact on safety and effectiveness |
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 1 stimulator channel with 8 virtual Positive and 15 virtual Negative output channels | 1 | The subject device is identical to the primary predicate device. Compared to the secondary predicate device, the subject device includes fewer physical stimulation channels. However, it achieves the same therapeutic effects and delivers equivalent stimulation parameters by incorporating a 24-channel high-voltage multiplexer (MUX). This MUX functions as an electronic switch that time-shares a single stimulation output across multiple electrodes in rapid succession.
Differences are considered minor with no impact on safety and effectiveness. |
| Number of EMG (input) Channels | 8 | Not publicly available | 2 | When compared to the secondary predicate device, differences are considered minor (therefore no impact on safety and effectiveness) since the subject and the predicate devices measure muscle activity via EMG by detecting the electrical signal during activity |
| EMG Sensitivity | 0.0298 μV | Not publicly available | 1 μV | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity |
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| EMG Sampling Rate | 2kHz | Not publicly available | 3kHz | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
|---|---|---|---|---|
| EMG detection (bipolar/monopolar) | Bipolar | Bipolar | Bipolar | Identical to both predicate devices |
| EMG range (μV) | +/-2.5*10⁶ μV | Not publicly available | 1-2000 μV | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
| EMG bandwidth | 10-500 Hz | Not publicly available | 70-480 Hz | When compared to the secondary predicate device, differences are considered minor since both devices measure muscle activity by detecting the electrical signal during activity. |
| EMG signal processing (e.g. RMS) | RMS (Root Mean Square) | Not publicly available | AVR (Average Rectified Value) | When compared to the secondary predicate device, differences in EMG signal processing does not lead to questions of safety and effectiveness because both RMS and AVR can be used to quantify the amplitude or magnitude of the EMG signal, providing an estimate of muscle activity |
| Synchronous or Alternating | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Method of Channel Isolation | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Regulated Current or Regulated Voltage | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Software/Firmware Microprocessor Control? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Automatic Overload Trip, No-Load Trip, Shut Off? | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Patient Override Control? | Yes (Stop Button) | Not publicly available | Yes (Stop Button) | Identical to the secondary predicate device |
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| Indicator Display On/Off Status? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
|---|---|---|---|---|
| Indicator Display: Low Batt? | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Indicator Display: Voltage Current Level? | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Timer Range (minutes) | Exercises 1-60 minutes | Not publicly available | 5-30 min | When compared to the secondary predicate device, differences in timer range are considered minor since overall intended uses are the same and ultimately achieve the same result i.e., muscle stimulation |
| Compliance with voluntary Standards? | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-10 | Not publicly available | IEC 60601-1 | ||
| IEC 60601-1-2 | ||||
| IEC 60601-2-10 | Identical to the secondary predicate device | |||
| Compliance with 21 CFR 898 | Yes | Not publicly available | Yes | Identical to the secondary predicate device |
| Weight | Control Unit (DC-200) 145g |
Sleeve (SL-200 Left and Right)
X-Small (S0) 220g
Small (S2) 230g
Medium (S4) 240g
Large (S6) 250g | DC-100 145 g
SL-100 Medium 240g
SL-100 Small 230g | 440 g | The subject device is identical to the primary predicate device in the weight of the Control Unit, Medium Sleeve, and Small Sleeve. The subject device's sleeve is available in X-small and Large. This difference is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences are insignificant and do not raise any issues related to safety and effectiveness |
| Dimensions [W x H x D] | Control Unit (DC-200) 136 x 54 x 24 mm
Sleeve (SL-200 Left and Right)
X-Small (S0) 500 x 600 mm
Small (S2) 520 x 610 mm
Medium (S4) 580 x 630 mm
Large (S6) 690 x 680 mm | DC-100 137 x 53 x 24 mm
SL-100 Medium 613 x 602 mm
SL-100 Small 596 x 560 mm | Device: 175 x 95 x 30 mm | The subject device's dimension is very similar when compared to the primary predicate device. This difference in dimension is insignificant and does not raise any issues of safety and effectiveness.
Although the appearance, weight, and dimensions are different between the subject and secondary predicate devices, these differences |
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| are insignificant and do not raise any issues related to safety and effectiveness | ||||
|---|---|---|---|---|
| Waveform (e.g., pulsed monophasic, biphasic) | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Shape | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Maximum Output Voltage (+/- 10%) [V] | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Maximum Output Current (+/- 10%) [mA] | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Pulse width | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Frequency [Hz] | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Net Charge [µC/pulse] (500Ω) | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Maximum Phase Charge[µC] @ 500Ω | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Maximum Current (RMS) Density [mA/cm²] | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Maximum Power Density [mW/cm²] | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| ON Time (seconds) | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| OFF Time (seconds) | N/A | Not publicly available | N/A | Identical to the secondary predicate device |
| Stimulation Threshold | 20% of the maximum activation level recorded during EMG Calibration | Not publicly available | Not publicly available | Although the threshold values for the predicate devices are not publicly available, the subject device's method is consistent with standard clinical practices and accepted safety margins in neuromuscular stimulation. As such, this difference does not raise concerns regarding safety or effectiveness. |
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VIII PERFORMANCE DATA
Summary of Nonclinical Performance Testing
The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve NS-200 performs as intended and is substantially equivalent to both predicate devices.
- Stimulation Output Waveforms
- Stimulation Output Specifications
- Stimulation Virtual Output Channels
- Stimulation Output Channel Isolation
- Hybrid Stimulation
- Stimulation Electrodes Short and/or Open Detection
- Wireless Coexistence
- Electrical Safety according to IEC 60601-1; IEC 60601-1-11
- Muscle and Nerve Stimulators according to IEC 60601-2-10
- Electromagnetic compatibility according to IEC 60601-1-2
- Software validation according to IEC 62304
The following non-clinical performance tests were leveraged from the predicate device submission because the addition of biofeedback and the minor software modifications did not affect the following testing areas for the subject device:
- Usability according to IEC 62366; IEC 60601-1-6 (Summative Evaluation)
Summary of Literature Clinical Data
The Cionic Neural Sleeve NS-200 stimulates dorsiflexors and evertors of the leg to provide foot eversion. There is no new intended use when compared to the intended use of the primary predicate device, NS-100 (K221823). The new indication of providing foot eversion is supported by the article titled "Augmenting Gait in a Population Exhibiting Foot Drop with Adaptive Functional Electrical Stimulation" (https://www.medrxiv.org/content/10.1101/2022.04.27.22273623v2.full).
IX CONCLUSION
The Cionic Neural Sleeve NS-200 has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware. Based on the result of the nonclinical testing, Cionic concludes that the device is substantially equivalent to both predicate devices.