Increasing local blood circulation,
. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
Preventing or retarding disuse atrophy
Edema reduction

Device Description

The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator (single unit) intended to provide continuous, sequential stimulation of the calf muscles. The FA100 SCCD designed to be user friendly and simple to use, with a large liquid crystal display (LCD) screen that displays the treatment mode currently in use and the selected intensity level for the patient to select a comfortable therapy session as recommended by the patient's healthcare provider.
The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies:

1. 4 Hz (program AA)
1. 9 Hz (program VE - the default setting of the device)
1. 14 Hz (program PA)
  Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.

AI/ML Overview

The provided document is a 510(k) Summary for the FlowAid Medical Technologies, Corp. FA100 SCCD (Sequential Continuous Contraction Device). This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not detail specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic or screening algorithm. Instead, the "acceptance criteria" are implied by the performance standards for powered muscle stimulators and the "study" is a clinical study supporting the device's indications for use.

Here's an attempt to extract the requested information based on the provided text, while acknowledging that some aspects (like expert ground truth and MRMC studies) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied by the electrical and functional specifications that demonstrate substantial equivalence to legally marketed powered muscle stimulators and the successful results of a clinical study for specific indications.

Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
Safety Standards	Compliance with relevant electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and specific nerve/muscle stimulator safety (IEC 60601-2-10) standards.	FA100 SCCD successfully passed all testing in accordance with internal requirements, national, and international standards, including IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
Software Validation	Compliance with software validation standards (IEC 62304).	FA100 SCCD successfully passed software validation per IEC 62304:2006.
Home Health Environment	Compliance with standards for equipment used in home health (IEC 60601-1-11).	FA100 SCCD successfully passed electrical testing per IEC 60601-1-11:2010.
Device Functionality	Device specifications (waveform, output voltage, current, pulse width, frequency, phase charge, current/power density) are within acceptable ranges for NMES devices.	All output specifications (e.g., max output voltage 80V, max output current 160mA, pulse width 500µsec, frequencies 4, 9, 14 Hz, max phase charge 8µC, max current density 6.4 mA/cm²) were found to be within acceptable ranges for NMES devices and comparable to or safer than predicate/other legally marketed devices.
Indications for Use (Edema Reduction)	Demonstrate effectiveness in reducing leg circumference for patients with chronic venous insufficiency.	A clinical study showed that the average circumference at both the ankle (21.9% decrease, p<.001) and calf (19.5% decrease, p<.001) decreased significantly with the FA100 SCCD. Adverse events: No adverse events were reported.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: 15 patients.
- Data Provenance: Retrospective or prospective is not explicitly stated, but the description of the study design ("FA100 SCCD was used in the home on the same leg for 2 hours daily for 30 days. The compression device was used for the same length of time on the other leg.") suggests a prospective clinical trial. The study was published in "J Vasc Med & Surg 2016", indicating an academic or clinical setting. Country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device (a powered muscle stimulator). The "ground truth" for its effectiveness is clinical outcome measures (leg circumference reduction) rather than expert interpretation of images or other data. The clinical study measured physical changes directly.
Adjudication method for the test set:
- This is not applicable. The outcome measures (leg circumference) were objective physical measurements, not subjective interpretations requiring adjudication.
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 FA100 SCCD is a therapeutic/rehabilitative device, not an AI-powered diagnostic or screening tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical device, not a standalone algorithm. Its performance is evaluated through its direct physiological effect on patients.
The type of ground truth used:
- Clinical Outcome Data: Specifically, objective physical measurements of leg circumference reduction at the ankle and calf.
The sample size for the training set:
- This is not applicable as the device is a hardware product, not a machine learning algorithm requiring a "training set." The clinical study involved 15 patients, which serves as the effectiveness data.
How the ground truth for the training set was established:
- This is not applicable for the same reasons as above. The clinical study measured objective physical changes directly.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2017

FlowAid Medical Technologies, Corp. Mr. Jacob Brezel CEO 44 Wall Street New York, New York 10005

Re: K162987

Trade/Device Name: FA100 SCCD (Sequential Continuous Contraction Device) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 4, 2017 Received: January 5, 2017

Dear Mr. Brezel:

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. 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 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162987

Device Name

FA100 SCCD (Sequential Continuous Contraction Device)

Indications for Use (Describe)

· Increasing local blood circulation
· Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Preventing or retarding disuse atrophy
Edema reduction

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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510(k) Summary

K162987

Traditional 510(k) Summary, as required by 21 CFR 807.92

A. Submitter: FlowAid Medical Technologies Corp. 44 Wall Street, 2nd Floor, New York, NY 10005

Contact person: Mr. Jacob Brezel, CEO Phone: (214) 461-3225 Email: Jacob@FlowAid.com

B. Date Prepared: February 13, 2017

ﻥ Device Name and Classification:

Trade name:	FA100 SCCD (Sequential Continuous Contraction Device)
Common name:	Neuromuscular Electrical Stimulator (NMES)
Classification name:	Powered Muscle Stimulator
Regulatory Class:	Class II
Product Code:	IPF
Review Panel:	Physical Medicine

D. Predicate Device: IF 3Wave - K050046

ن Device Description:

The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies:

1. 4 Hz (program AA)
1. 9 Hz (program VE - the default setting of the device)
1. 14 Hz (program PA)

Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set

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by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.

Indication for Use/Intended Use: F.

The FA100 SCCD is indicated for use in:

Increasing local blood circulation,
. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
Preventing or retarding disuse atrophy
Edema reduction

G. Substantial Equivalence

The table below provides the basic unit characteristics and output specifications for the subject and predicate device as outlined in the Powered Muscle Stimulator Guidance Document issued on June 9, 1999.

	New Device	Predicate Device	Basis for SubstantialEquivalence
510(k) Number	K162987	K050046	N/A
Device Name & Model	FA100 SCCD	IF 3Wave	NA
Manufacturer	FlowAid	Empi	N/A
Indications for Use	As a muscle stimulator Increase local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Prevention or retardation of disuse atrophy Reduction of edema	As a muscle stimulator Increase local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Relax muscle spasms Prevent or retard disuse atrophy Maintain or increase range of motion Muscle re-education As a Pulsed DC Stimulator Reduction of edema (under the negative electrode) Reduction of muscle spasm	Indications for new device are a subset of those for predicate device.* Clinical data is provided to support indications for use.
	New Device	Predicate Device	Basis for SubstantialEquivalence
		Influencing local blood circulation (under the negative electrode) Retardation or prevention of disuse atrophy Facilitation of voluntary motor function Maintenance or increase of range of motion As an interferential stimulator Relieve acute pain Relieve and manage chronic pain Relax muscle spasms Maintain and increase the range of motion Increase local blood circulation
Basic Unit Characteristics
Power Source	Four 1.2VDC GP NiMHbattery cells	Rechargeable lithium-ionpolymer battery	Both devices arebattery powered.
Method of IsolatingUser from Mains	Plastic slider over thecharging port preventscharging when electrodecable is connected to thedevice	Not stated in 510(k)Summary	New device cannot beused for treatmentwhen the battery isconnected to mainsfor charging.
Number of OutputModes	1NMES	3NMESPulsed stimulationInterferential stimulation	New device is a subsetof predicate device.*
Number of OutputChannels	4	2	New device has 4output channels, but
Synchronous oralternating?	Sequential Stimulation ofelectrode pairs:4-1, 1 - 2, 2 - 3, 3 - 4	Unknown	only 2 are active at atime.*
Method of channelisolation?	Capacitor	Transformer	Both are acceptedmethods of channelisolation.
	New Device	Predicate Device	Basis for SubstantialEquivalence
Regulated current orvoltage	Current regulated	Current regulated	Same
Microprocessorcontrolled?	Yes	Yes	Same
Automatic overloadtrip	Yes	No	Automatic overloadtrip of new device isadded safety feature.
Automatic no-load trip	Yes	Yes	Same
Automatic shut-off	Yes - at end of battery life,approximately 50 hours ofcontinuous treatment	Yes	Same
Patient over-ridecontrol	Yes	Yes	Same
Indicator Display:			Same
- On/off status	Yes	Yes
- Low battery	Yes	Yes
- Voltage/ currentlevel	Yes – numerical indicationof signal intensity (voltagevalue)	Yes
Number of PresetPrograms	3	3 for NMES	Same for NMES
Timer range in minutes	No timerDevice will operate untilturned off by user orbattery depleted.	10 – 60 min in 5 minincrements	Timer not needed forsafe application.
Compliance withvoluntary standards	Yes	Yes	Same
Compliance with 21CFR 898	Yes	Not stated in 510(k)Summary	Compliant withelectrodeperformancestandard.
Weight	230 g, including batteries	340 g, including battery	Both are lightweightand portable.
Dimensions	2.8" x 5.1" x 1.1"	3.9" x 6.3" x 1.4"	Both are small.
Housing Materials ofConstruction	Injection molded plastic	Injection molded plastic	Same
	New Device	Predicate Device	Basis for SubstantialEquivalence
Output Specifications
Waveform	Symmetrical bi-phasicrectangular wave with 0net DC	NMES - Symmetrical bi-phasic square wave with 0net DC	Essentially the same.
Maximum outputvoltage (500 Ω load)	80 V (±10%)	Not stated in 510(k)Summary	80V is within theacceptable range ofmax voltage for NMESdevices.*
Maximum outputcurrent (500 Ω load)	160 mA (±10%)	100 mA	160 mA is within theacceptable range ofmax current for NMESdevices.*
Pulse Width	Fixed – 500 µsec	70 – 300 µsec	500 µsec is within theacceptable range ofpulse widths for NMESdevices.*
Frequency	4 Hz, 9 Hz, or 14 Hzdepending on therapysetting	10 – 80 Hz	4, 9 and 14 Hz arewithin the acceptablerange of frequenciesfor NMES devices.*
Net charge - howachieved	0 µC, phase balancing	0 µC, phase balancing	Same
Maximum phasecharge	8 µC	30 µC for NMES60 µC for Pulsed	8 µC is within theacceptable range ofphase charge forNMES devices*
Maximum CurrentDensity	6.4 mA/cm²	0.19 mA/cm² for NMES(average)0.13 mA/cm² for Pulsed(average)	6.4 mA/cm² is withinthe acceptable rangeof current densitiesfor NMES devices.*
Maximum PowerDensity	0.000041 W/cm²	0.019 W/cm² for NMES(average)0.013 W/cm² for Pulsed(average)	0.000041 W/cm² iswithin the acceptablerange of powerdensities for NMESdevices.*
Burst mode	N/A	N/A	Same
ON Time (sec)OFF Time (sec)	Sequential channelactivation. Channel ON andOFF times depend onprogram (frequency).	ON: 1 – 30 sOFF: 1-60 s	Sequential continuouscontraction pattern ofnew device issubstantiallyequivalent to
	New Device	Predicate Device	Basis for SubstantialEquivalence
	Program AA (4 Hz)ON: 1 s, OFF: 3 sProgram VE (9 Hz):ON: 0.44 s; OFF: 1.32 sProgram PA (14 Hz):ON: 0.29 s; OFF: 0.87 sOne channel always ON forcontinuous stimulation.		predicate and otherNMES devices thatoffer varying ON / OFFpatterns for electrodestimulation.*
Electrodes	Manufactured by Top Rank,China and cleared underK132588.Hydrogel applied to silverelectrode. Biocompatibilityhas been established.Single patient use, can bereused many times beforedisposal, recommendreplacing every 10 days.	Electrode pads notdescribed in 510(k)Summary	FA100 SCCDelectrodes werepreviously cleared byFDA.

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*See Discuss of Differences below.

Discussion of Differences

FDA has cleared more than 500 powered muscle stimulators under Product Code IPF, encompassing a wide variety of technical specifications, all of which have been found safe and effective for neuromuscular electrical stimulation. Where appropriate, other legally marketed NMES devices are cited below to demonstrate that the technological differences of the FA100 SCCD as compared to the named predicate device do not raise new questions of safety or effectiveness that have not previously been considered by FDA for NMES devices. In addition, clinical data from studies of the FA100 SCCD are summarized in Section I of this 510(k) Summary to support the safety and effectiveness of the new device for its indications for use.

1. Indications for Use: The FA100 SCCD indications for use are a subset of the predicate indications for use. The proposed indications for the FA100 SCCD are all supported by clinical studies conducted using the device (see Section I). The FA100 SCCD does not have any indications for use that are not also cleared for the predicate device; therefore, no new questions of safety or effectiveness are raised by this difference.
1. Number of output channels: The FA100SCCD has four output channels as compared to two for the predicate device. However, this does not raise any new questions of safety or effectiveness because only one channels is active at any one time to drive one electrode pair. In addition, FDA has cleared many other NMES devices that have

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more than two output channels (e.g., RS-4i Plus Sequential Stimulator, K112348, providing options of 2, 4, or 8 electrodes applied to multiple anatomical sites).

1. Maximum output current (stimulus intensity): The stimulus intensity of the FA100 SCCD is set to achieve visible contraction of the calf muscles at a level tolerable to the patient. Stimulus intensity can be varied from 1V to 80V in 1V increments. The maximum voltage corresponds to a maximum current of 160 mA, which is somewhat higher than that of the predicate device (100 mA max), but is within the specifications for other legally marketed NMES devices (e.g., Sys*Stim 208/208A, K031017, with a maximum output voltage of 92 V and a maximum output current of 184 mA).
1. Pulse width: The FA100 SCCD has a fixed pulse width of 500 µsec, which is somewhat longer than that of the predicate device (300 usec max), but is within the specifications for other legally marketed NMES devices (e.g., geko T-1, K133638, 560 usec max pulse width).
1. Frequency: The FA100 SCCD offers three stimulus settings that differ only in the pulse frequency: 4 Hz, 9 Hz and 14 Hz. While the two lowest frequencies are somewhat lower than the range offered by the predicate device (10 – 80 Hz), they are within the range offered by other legally marketed NMES devices (e.g., geko T-1, K133638, 1 Hz fixed pulse frequency). Clinical data are provided to demonstrate that the low frequency settings of the FA100 SCCD are safe and effective for the device intended uses.
1. Maximum phase charge: The 8 µC max phase charge for the FA100 SCCD is lower than that of the predicate device (30 µC max for NMES), which indicates added safety for the new device. Clinical data are provided to demonstrate that the FA100 SCCD is effective for its intended uses.
1. Maximum current density: The 6.4 mA/cm² max current density for the FA100 SCCD is higher than the current density stated in the 510(k) summary for the predicate device (0.19 mA/cm² for NMES); however, this is stated as an average, not maximum, current density. The max current density for the FA100 SCCD is the same as that for the geko T-1 (6.67 mA/cm², see K133638).
Maximum power density: The 0.000041 W/cm² max power density for the FA100 8. SCCD is lower than for the predicate device (0.019 W/cm² for NMES, stated as average), but is the same as that of the geko T-1 (0.000044 W/cm², see K133638).
1. Stimulation sequence (On/Off times): The FA100 SCCD provides a continuous sequential stimulation pattern in which one of the four channels are on at a time. The On and Off times for each channel are driven by the chosen frequency. The predicate device and many other powered muscle stimulators provide flexibility to enable varying On and Off times for each channel.

H. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the FA100 SCCD and to comply with the requirements of the FDA Guidance Document "Guidance Document for Powered Muscle Stimulator 510k's) and to demonstrate substantial equivalence to the predicate device, FlowAid has completed a number of non-clinical performance tests. The FA100 SCCD

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meets established requirements for overall design, electrical safety and software validation confirming that the design outputs meet design input requirements and established specifications.

The FA100 SCCD device successfully passed all testing in accordance with internal requirements, national and international standards and the FDA Guidance Document cited above. These included:

Electrical safety per IEC 60601-1:2012
EMC testing per IEC 60601-1-2: 2007
Electrical testing per IEC 60601-2-10:2012 (Particular requirements for the ● safety of nerve and muscle stimulators)
. Electrical testing per IEC 60601-1-11:2010 (Basic safety, equipment used in home health environment
. Software validation per IEC 62304:2006

The FA100 SCCD passed all the testing in accordance with internal requirements, national standards, and international standards. Internal verification and validation testing confirms that all product specifications and user requirements have been met, which support the intended use and technological characteristic of the device when compared to the predicate device. The information presented supports that the FA100 SCCD is substantially equivalent to the referenced predicate device.

l. Clinical Performance Data:

Publication	Summary
Gimmelreich D, Karsilnikov V,Litman L, Rosenblum J.Sequential contractioncompression devices reduce legcircumference in patients withchronic venous insufficiency. JVasc Med & Surg 2016;4(4):283. doi 10.4172/2329-6925.1000283.	Compared the use of the FA100 SCCD to compression therapy for thetreatment of edema in 15 patients with chronic venous insufficiency (CVI) inboth legs. The FA100 SCCD was used in the home on the same leg for 2hours daily for 30 days. The compression device was used for the samelength of time on the other leg. After 30 days of treatment, the averagecircumference at both the ankle and calf decreased for the legs treatedwith the FA100 SCCD (21.9% and 19.5%, respectively, both p<.001). Inaddition, the average changes in ankle and calf circumference were greaterfor the FA100 SCCD treated legs as compared to the legs treated withcompression. No adverse events were reports.

Publication

Summary

Gimmelreich D, Karsilnikov V,Litman L, Rosenblum J.Sequential contractioncompression devices reduce legcircumference in patients withchronic venous insufficiency. JVasc Med & Surg 2016;4(4):283. doi 10.4172/2329-6925.1000283.

Compared the use of the FA100 SCCD to compression therapy for thetreatment of edema in 15 patients with chronic venous insufficiency (CVI) inboth legs. The FA100 SCCD was used in the home on the same leg for 2hours daily for 30 days. The compression device was used for the samelength of time on the other leg. After 30 days of treatment, the averagecircumference at both the ankle and calf decreased for the legs treatedwith the FA100 SCCD (21.9% and 19.5%, respectively, both p<.001). Inaddition, the average changes in ankle and calf circumference were greaterfor the FA100 SCCD treated legs as compared to the legs treated withcompression. No adverse events were reports.

J. Statement of Substantial Equivalence:

FlowAid has demonstrated that the FA100 SCCD (Sequential Continuous Contraction Device) is substantially equivalent to the predicate device because it has the same intended use as a powered muscle stimulator, is intended to be used for a subset of the indications for use, and has similar technological characteristics. Clinical data are provided to demonstrate that the FA100 SCCD is safe and effective for the proposed indications for use.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).