The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

· Facilitate muscle re-education
· Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
· Increase local blood flow

Device Description

The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.

The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:

1. External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
1. Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
1. Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
1. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
1. Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
1. Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
1. Electrode and electrode bases which are attached to the inner side of the lower leg cuff.

The L100 Go System can be operated in one of the following modes:

Gait Mode
Training Mode •
. Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a modified medical device, the L100 Go System. The submission claims substantial equivalence to a legally marketed predicate device, the L300 Go System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes modifications to a pre-existing medical device, the L300 Go System, resulting in the L100 Go System. The acceptance criteria are implicit in the claim of "substantial equivalence" to the predicate device and the successful completion of "verification testing" for the modified components. Since this is a Special 510(k) for device modifications, specific performance metrics are not explicitly presented as acceptance criteria and reported performance in a table format. Instead, the document focuses on demonstrating that the changes do not negatively impact the safety and effectiveness, and that the modified components meet their design specifications.

The provided text states:

"The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality."
"The L100 Go System has been verified and validated successfully for its intended use through the combination of predicate device bench testing and thorough verification and validation testing of all changes."
"Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System."

This indicates that the acceptance criteria were that the modified cuff design would show no loss of mechanical strength and functionality compared to the predicate device, and that all changes would pass verification and validation testing to confirm safety and effectiveness for its intended use.

The reported device performance is that these tests were "successfully" completed, affirming that the L100 Go System maintains substantial equivalence to the L300 Go System despite the modifications.

2. Sample size used for the test set and the data provenance:

The document describes "nonclinical tests" and "verification and validation testing of all changes." However, it does not specify the sample size used for these tests. The data provenance is also not explicitly stated beyond being "nonclinical testing" performed by the manufacturer (Bioness Inc.). It is implied to be laboratory/bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. As the testing focuses on mechanical strength and functionality of hardware modifications, the "ground truth" would likely be established by engineering and quality control experts within Bioness, following established testing protocols, rather than medical experts for clinical performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. As it's nonclinical verification testing, formal adjudication methods by external experts, as seen in clinical studies, are typically not applicable. The results would be assessed against pre-defined engineering and performance specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device (L100 Go System) is an external functional neuromuscular stimulator for foot drop, not an AI-powered diagnostic or assistive technology for human "readers." Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The L100 Go System is a physical medical device (an external functional neuromuscular stimulator), not an algorithm or software-only device. Its performance inherently involves the device interacting with a patient's body under clinician or patient control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "nonclinical tests" related to the modified cuff design, the ground truth would be based on engineering specifications and established performance standards for mechanical strength and functionality. This would involve objective measurements (e.g., tensile strength, durability, electrical output parameters) compared against pre-defined thresholds derived from the predicate device and relevant industry standards (e.g., IEC 60601 series).

8. The sample size for the training set:

This is not applicable. The L100 Go System is a modified physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 4, 2020

Bioness Inc. Shanna Hu Regulatory Affairs Manager, FES Technology 25103 Rye Canyon Loop Valencia, California 91355

Re: K200262

Trade/Device Name: L100 Go System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: January 31, 2020 Received: February 3, 2020

Dear Shanna Hu:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

For Vivek Pinto, Ph.D. 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

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Indications for Use

510(k) Number (if known)

Device Name L100 Go System

Indications for Use (Describe)

The L100 Go System may also:

· Facilitate muscle re-education
· Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
· Increase local blood flow

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)

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Image /page/3/Picture/1 description: The image shows the logo for Bioness. The logo features an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below it. The logo is simple and modern, and the colors are bright and cheerful.

510(k) Summary:	L100 Go System
Applicant Name:	Bioness Inc.
Contact Person(s):	Shanna HuRegulatory Affairs Manager, FES TechnologyBioness Inc.25103 Rye Canyon LoopValencia, CA 91355, U.S.AOffice Number: (661) 362-6694Email: shanna.hu@bioness.comMercedes BayaniGlobal Vice-President, Clinical & Regulatory AffairsBioness Inc.Office Number: (661) 902-5324Fax Number: (661) 362-4851Email: mercedes.bayani@bioness.com
Date Prepared:	March 4, 2020
Trade Name:	L100 Go System
Classification:	Name: External functional neuromuscular stimulatorProduct Code: GZI and IPFRegulation No: 21 CFR § 882.5810, § 890.5850Class: IIClassification Panel: Neurology

Establishment Registration No.: 3004553866

Reason for Submission: Device Modifications

Type of Submission: Special 510(k)Type of Submission:Special 510(k)

Predicate Device:

Company: Bioness, Inc. Device: L300 Go System, K190285

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Image /page/4/Picture/1 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller gray font below the word "Bioness". The sun-like symbol has eight orange rays, each made up of two lines that curve inward.

Purpose of this Special 510(k):

This Special 510(k) is submitted for a system called L100 Go System which is the same device as the Lower Leg configuration of the predicate L300 Go System with modified cuff design. None of the modifications affect the intended use of the device nor do they alfer the fundamental scientific technology of the device.

Device Description:

The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:

1. External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
1. Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
1. Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
1. Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
1. Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
1. Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
1. Electrode and electrode bases which are attached to the inner side of the lower leg cuff.

The L100 Go System can be operated in one of the following modes:

Gait Mode
Training Mode •
. Clinician Mode

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Image /page/5/Picture/1 description: The image shows the logo for Bioness LiveOn. The logo features an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and "LiveOn" in a smaller font below it. The logo is simple and modern, with a focus on the company name.

Indications for Use:

The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

Facilitate muscle re-education .
Prevent/retard disuse atrophy .
Maintain or increase joint range of motion ●
Increase local blood flow ●

Modifications Addressed in this Special 510(k)

This Special 510(k) addresses the new L100 Go Cuff which is a modification of the predicate L300 Go lower leg cuffs. The L100 Go Cuff combines the design elements of both the L300 Go lower leg Reqular and Small cuffs.

Summary of Technological Characteristics

The Table below summarizes the technological characteristics of the subject device in comparison to those of the predicate device, specifically, the lower leg configuration of the predicate device.

	L300 Go System(K190285)	L100 Go System (thissubmission)	EquivalencyAssessment
Manufacturer	Bioness Inc.	Bioness Inc.	Same
510(k) number	K190285	To be assigned	N/A
Product code	GZI & IPF	GZI & IPF	Same
	L300 Go System(K190285)	L100 Go System (thissubmission)	EquivalencyAssessment
Intended use	The L300 Go System isintended to provide ankledorsiflexion in adult andpediatric individuals withfoot drop and/or to assistknee flexion or extension inadult individuals withmuscle weakness related toupper motor neurondisease/injury (e.g., stroke,damage to pathways to thespinal cord). The L300 GoSystem electricallystimulates muscles in theaffected leg to provideankle dorsiflexion of thefoot and/or knee flexion orextension; thus, it also mayimprove the individual'sgait.The L300 Go System mayalso:• Facilitate muscle re-education• Prevent/retard disuseatrophy• Maintain or increase jointrange of motion• Increase local blood flow	The L100 Go System isintended to provide ankledorsiflexion in adults withfoot drop or muscleweakness related to uppermotor neuron disease/injury(e.g., stroke, damage topathways to the spinal cord).The L100 Go Systemelectrically stimulatesmuscles in the affected legto provide ankle dorsiflexionof the foot; thus, it also mayimprove the adult's gait.The L100 Go System mayalso:• Facilitate muscle re-education• Prevent/retard disuseatrophy• Maintain or increase jointrange of motion• Increase local blood flow	Same(The intended use ofL100 Go System is asubset of thepredicate device.The L100 Go Systemis a lower leg cuffonly system,therefore, it does notassist knee flexion orextension)
Number ofOutput Modes	2 modes: BiphasicAsymmetric and Symmetric	2 modes: BiphasicAsymmetric and Symmetric	Same
Number ofPrograms	• Gait• Training/Exercise• Cycle Training Mode• Clinician mode	• Gait• Training/Exercise• Clinician mode	Different(Cycle Training Modeis disabled for theL100 Go System)
RegulatedCurrent orRegulatedVoltage	Current	Current	Same
	L300 Go System(K190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
Power Source	Control Unit: Li Coin Cell,CR2032, 3 V, 240 mAhEPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAhFoot Sensor: Li Coin Cell,CR2032, 3 V, 240 mAh	EPG: Rechargeable, Li-Ion,Prismatic, 3.7 V, 1000 mAh	Same(optional Control Unitand Foot Sensor arenot offered with theL100 Go System)
Method of LineCurrentIsolation	N/A (Battery operated)	N/A (Battery operated)	Same
PatientLeakageCurrent,Normalcondition [μA]	Less than 1.0 (IEC 60601-1)	Less than 1.0 (IEC 60601-1)	Same
PatientLeakageCurrent, Singlefault condition[μA]	3.0 (IEC 60601-1)	3.0 (IEC 60601-1)	Same
Number ofOutput Modes	Two: Symmetric &Asymmetric	Two: Symmetric &Asymmetric	Same
Number ofOutputChannels	Small lower leg cuff: 1Regular lower leg cuff: 1 or2Thigh cuff: 1	Lower leg cuff: 1	Same(The L100 Go lowerleg cuff has the sameoutput channel asthe L300 Go smalllower leg cuff)
Synchronousor Alternating?	Alternating (at one timeonly one channel isactivated)	N/A (only one channel willbe activated)	Same(L100 Go cuff issingle channeled.This is the same asL300 Go small lowerleg cuff)
Method ofChannelIsolation	Isolation between lower legand thigh cuff stimulators:Thigh and Lower cuffs arestimulated by differentbattery operated EPG'swithout galvanic connectionbetween them.Isolation between channelswithin the regular lower cuff	Isolation between channelswith the lower leg cuffstimulator: N/A(Only one channel will beactivated)	Same(The isolationbetween channels isnot applicable toL100 Go lower legcuff stimulator, this isthe same as L300Go small lower legcuff stimulator)
	L300 Go System(K190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
	same EPG are switchedusing high voltage FETswitches.
	Isolation between channelswithin the small lower cuffstimulator: N/A (only onechannel will be activated)
	Isolation between channelswithin the Thigh cuffstimulator: N/A (only onechannel will be activated)
RegulatedCurrent orRegulatedVoltage?	Current	Current	Same
Software/Firmware/Microprocessor-Controlled	Yes	Yes	Same
AutomaticOverload Trip?	Yes	Yes	Same
Automatic No-Load Trip?	Yes	Yes	Same
Automatic ShutOff?	Yes	Yes	Same
PatientOverrideControl?	Yes	Yes	Same
IndicatorDisplay:• On/OffStatus?• Low Battery?•Voltage/Current Level?	YesYesYes	YesYesYes	Same
Timer Range[minutes]	No	No	Same
	L300 Go System(K190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
Max OutputCurrent(± 10%)	Lower leg cuffs:100 mA @ 500 OhmThigh cuff:100 mA @ 500 Ohm	Lower leg cuff:100 mA @ 500 Ohm	Same(L100 Go lower legcuff has the samemaximum outputcurrent as the L300Go lower leg cuff.Thigh cuff is notavailable in the L100Go System)
Max AverageCurrent Density[mARMS/cm2][Over smallestelectrode]	Lower leg EPG:small cuff, small roundelectrodes (36mm)$1.27 \text{ mA}{\text{RMS}}/\text{cm}^{2}$ (500 Ω,Irms=13.0 mA, electrodearea of 10.2 cm2)Thigh EPG: $0.18 \text{mA}{\text{RMS}}/\text{cm}^{2}$(500 Ω, Irms=13.0 mA,electrode area of 74 cm2)	Lower leg EPG:Lower leg cuff, regular roundelectrodes (45mm)$0.82 \text{mA}_{\text{RMS}}/\text{cm}^{2}$ (500 Ω,Irms=13.0 mA, electrode areaof 15.9 cm2)	Different(since L100 Go cuffonly comes in thesize same as thepredicate regularcuff, the calculationis based on theelectrode of theregular cuff. Thighcuff is not availablein the L100 GoSystem)
Max AveragePower Density,(mW/cm2)	Lower leg EPG:small cuff, small roundelectrodes (36mm)$8.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,Irms=13.0 mA, electrodearea of 10.2 cm2)regular cuff, regular roundelectrodes (45mm)$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,Irms=13.0 mA, electrodearea of 15.9 cm2)Thigh EPG:$1.1 \text{mW}/\text{cm}^{2}$ (500 Ω,Irms=13.0mA, electrode areaof 74 cm2)	Lower Leg EPG:Lower leg cuff, regular roundelectrodes (45mm)$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,Irms=13.0 mA, electrode areaof 15.9 cm2)	Same(L100 Go cuff onlycomes in regularsize)
	L300 Go System(K190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
StimulationChannels	Regular Cuff: 1 or 2 (In 2-channelmode, both function as asingle channel but withseparatelyadjustable medial/ lateralstimulationintensity)Small Cuff: 1Thigh Cuff: 1	Lower leg cuff: 1	Same(L100 Go has onestimulation channelwhich is identical tochannel #1 of L300Go Regular Cuff)
Frequency/Phase duration	Frequency: 10, 15, 20, 25,30, 35, 40, 45 HzSymmetric and Asymmetricpositive: 100, 150, 200,250, 300μs;Asymmetric Negative: 300,450, 600, 750, 900μs;	Frequency: 10, 15, 20, 25,30, 35, 40, 45 HzSymmetric and Asymmetricpositive: 100, 150, 200, 250,300μs;Asymmetric Negative: 300,450, 600, 750, 900μs;	Same
Electrodesused in thesystem	Lower Leg Cuffs:• 2 Hydro-Gel electrodesassembled onelectrode bases, or• 2 non-woven clothelectrodes assembledon electrode bases, or• 2 non-woven clothelectrodes attachedwith snaps (also called"QuickFit" electrodes),or• 3 non-woven clothelectrodes attachedwith snaps (segmentedelectrodes [also called"steering" electrodes],using common anodeto allow separateadjustment of medialand lateral stimulation.This electrode is onlyused for regular cuff)Thigh Cuff:• 2 single, non-wovencloth electrodesattached with snaps	Lower leg Cuff:• 2 Hydro-Gel electrodesassembled on electrodebases, or• 2 non-woven clothelectrodes assembledon electrode bases, or• 2 non-woven clothelectrodes attachedwith snaps (also called"QuickFit" electrodes)	Different(L100 Go does notuse steeringelectrodes)
	L300 Go System(K190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
ClinicianControl/Programming	Clinician uses the ClinicianProgrammer (CAPP) to setstimulation energy andtemporal parametersrelated to the functionalstimulation performance fordorsiflexion control	Clinician uses the ClinicianProgrammer (CAPP) to setstimulation energy andtemporal parameters relatedto the functional stimulationperformance for dorsiflexioncontrol	Same
ClinicianProgrammer(CAPP)Platform	Tablet PC	Tablet PC	Same
User Control	Using hand-held ControlUnit, the mobile application(MAPP), or the EPG-basedinterface, the user can:Turn system On/Off(EPG only)Start/Stop stimulationSelect Gait/TrainingprogramFine-tune stimulationintensity aroundworking point set bythe clinicianTest L300 Lower LegEPG & Thigh EPGstimulation beforestarting to ambulate	Using the mobile application(MAPP), or the EPG-basedinterface, the user can:Turn system On/Off(EPG only)Start/Stop stimulationSelect Gait/TrainingprogramFine-tune stimulationintensity aroundworking point set bythe clinicianTest L100 Lower LegEPG stimulation beforestarting to ambulate	Same(Control Unit isoptional, and is notoffered with the L100Go System)
Stimulationtrigger source(when used forgait)	In gait mode, stimulation istriggered by:(1) the motion sensorembedded in the EPG(two-dimension tilt); or(2) Foot Sensor thatdetects Heel On &Heel Contact eventsduring gait andtransmits themwirelessly to the lowerand thigh EPGs.	In gait mode, stimulation istriggered by:(1) the motion sensorembedded in the EPG(two-dimension tilt).	Same(Foot Sensor isoptional, and is notoffered with the L100Go System)
	L300 Go System (190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
Communication method	Control Unit - Lower Leg/Thigh EPG: wirelessBluetooth (Low Energy)communication protocolGait Sensor - LowerLeg/Thigh EPG: wirelessBluetooth (Low Energy)communication protocolClinician Programmer -EPG:wireless Bluetooth (LowEnergy) communicationprotocolMAPP – Lower Leg /ThighEPG: wireless Bluetooth(Low Energy)communication protocol	Clinician Programmer -EPG:wireless Bluetooth (LowEnergy) communicationprotocolMAPP – Lower Leg /ThighEPG: wireless Bluetooth(Low Energy)communication protocol	Same(Control Unit andFoot Sensor areoptional, and are notoffered with the L300Go System)
Compliancewith VoluntaryStandards	Yes.• IEC 60601-1• IEC 60601-2-10• IEC 60950-1• IEC 60601-1-11• IEC 60601-1-2FCC part 15:2007 FederalCommunicationsCommission (FCC)regulations Subpart C,15.247	Yes.• IEC 60601-1• IEC 60601-2-10• IEC 60950-1• IEC 60601-1-11• IEC 60601-1-2FCC part 15:2007 FederalCommunicationsCommission (FCC)regulations Subpart C,15.247	Same
Compliancewith 21 CFR898?	Yes	Yes	Same
Weight	EPG: 60 [gram]Lower leg regular Cuff: 150[gram]Lower leg small Cuff: 104[gram]	EPG: 60 [gram]Lower Leg Cuff: 127 [gram]	Different(The L100 Go Cuff islighter compared tothe L300 Go lowerregular cuff, this isbecause the L100Go cuff does nothave the TPU frame)
	L300 Go System (190285)	L100 Go System (Thissubmission)	EquivalencyAssessment
Dimensions[mm] (WxHxD)	EPG: 82x47x15 [mm]Lower leg regular Cuff:160x100x125 [mm]Lower leg small Cuff:110x80x100 [mm]	EPG: 82x47x15 [mm]Lower Leg Cuff:160x100x125 [mm]	Same(The L100 Go cuffhas the samedimension as theL300 Go lowerregular Cuff)

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The difference between the predicate device and the device in this submission is in the number of programs offered, the availability of the optional Control Unit and Foot Sensor, the number of available electrodes, and the weight of the subject device is a simpler system, therefore, the Cycle Training Mode feature is disabled. For the same reason, the optional Control Unit and Foot Sensor that are offered with the predicate device is not offered with the subject device. Furthermore, the subject device, the L100 Go System, is a single channel system, therefore, the steering electrode which is used for 2 channel stimulation is not applicable. These technological differences do not affect the safety and effectiveness of the subject device.

Summary of Nonclinical Tests Submitted

The modified cuff design was subjected to verification testing to ensure no loss of mechanical strength and functionality.

Conclusion:

The L100 Go System has been verified and validated successfully for its intended use through the combination of predicate device bench testing and thorough verification and validation testing of all changes. Based on the result of the nonclinical testing, Bioness concludes that the device is substantially equivalent to the predicate L300 Go System.

Regulation Number and Section

§ 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).