It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The FastFit EMS System is Rx only.

Device Description

The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components:

FastFit Exercise Suit
EMS Controller
Power Adaptor
FastFit Software Application

The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals.

EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.

AI/ML Overview

This document is a 510(k) Summary for the FastFit EMS System, seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a comparative study proving the device meets specific performance metrics in a clinical or AI-assisted context.

Therefore, I cannot provide the requested information as the document does not describe acceptance criteria or a study proving the device meets such criteria.

The document focuses on demonstrating substantial equivalence based on:

Indications for Use: The FastFit EMS System is intended to stimulate healthy muscles to improve or facilitate muscle performance, similar to the predicate devices.
Technological Features: A detailed comparison of the FastFit EMS System with its predicate devices (Compex® Wireless USA and Katalyst Mark 1 Muscle Stimulation System) regarding their design, power source, charging, output specifications, and interfaces.
Nonclinical Testing: Summary of tests performed including system design verification, software verification/validation, electrical safety, electromagnetic compatibility, biocompatibility, and usability/human factors testing. These tests confirm the device's basic functionality and safety, but not its performance against specific acceptance criteria for efficacy in a clinical setting with human subjects or AI-assisted readings.

The document explicitly states: "The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues. Based on the above information, FastFit believes that the substantial equivalence of the FastFit EMS system to the Compex Wireless USA and Katalyst Mark 1 has been demonstrated." This indicates the submission is for regulatory clearance based on substantial equivalence, not for demonstrating specific performance metrics against pre-defined acceptance criteria through a comparative study.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 22, 2020

Fast Fit LLC % Sigi Caron Regulatory Consultant Biologics and Medical Device Consulting Group 20370 Skyhawk Lane Topanga, CA 90290

Re: K192161

Trade/Device Name: FastFit EMS System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 24, 2019 Received: October 24, 2019

Dear Sigi Caron:

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.

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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 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 (QS) 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 medical devices and radiation-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) K192161

Device Name FastFit EMS System

Indications for Use (Describe)

The FastFit EMS System is intended to simulate healthy muscles in order to improve or facilitate muscle performance.

The FastFit EMS System is Rx only.

Type of Use (Select one or both, as applicable)

|--|--|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

DATE PREPARED	August 6, 2019
APPLICANT	Fast Fit LLC450 Park Avenue31st FloorNew York, NY 10022
OFFICIALCORRESPONDENT	Sigi Caron, MBA RACBiologics and Medical Device Consulting Group20370 Skyhawk LaneTopanga, CA 90290Tel: (310) 455-3473Fax: (888) 295-1535sigi@BioMDG.com
TRADE NAME	FastFit EMS System
COMMON NAME	Stimulator, Muscle Powered, for Muscle Conditioning
DEVICE CLASSIFICATION	Name: Powered Muscle StimulatorRegulation No: 21 CFR §890.5850Product Code: NGX - Stimulator, Muscle Powered, forMuscle ConditioningClass: II
PREDICATE DEVICE	Compex® Wireless USA (K143551)Katalyst Mark 1 Muscle Stimulation System (K181199)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

FastFit Exercise Suit
EMS Controller
Power Adaptor
FastFit Software Application

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INDICATIONS FOR USE:

The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The FastFit EMS System is Rx only.

SUBSTANTIALLY EQUIVALENT TO:

The FastFit EMS System is substantially equivalent in intended use and technological features to two other commercially available powered muscle stimulator systems:

. Compex® Wireless USA (K143551)
. Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199)

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The FastFit EMS system is substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The following table compares the features of the proposed device and its predicates.

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Element	New Device:FastFit EMS System	Primary Predicate:Compex Wireless USA	Secondary Predicate:Katalyst Mark 1 MuscleStimulation System Model 2
510(k) Number	---	K143551	K181199
Indications for Use	The FastFit EMS system "isintended to stimulatehealthy muscles in order toimprove or facilitate muscleperformance.It is not intended to be usedin conjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind."None of the stimulationprograms or operationalparameters are designed totarget injured or ailingmuscles and its use on suchmuscles is contraindicated."The FastFit EMS system isRx only.	The Compex Wireless USAis an Over-The-Counterdevice "intended tostimulate healthy musclesin order to improve orfacilitate muscleperformance." It is to beused by adults only. TheCompex Wireless USA is"not intended foradjunctive therapy in thetreatment of medicaldiseases and conditions ofany kind." None of theCompex Wireless USAstimulation programs aredesigned for injured ordisease afflicted muscles. Itsuse on such muscles iscontraindicated. The workimposed on the muscles bythe Compex Wireless USAelectrical impulses allow thetriggering of actionpotentials of motoneuronesare transmitted to themuscle fibers via the motorendplate where theygenerate mechanical musclefiber responses thatcorrespond to muscle work.Depending on theparameters of the electricalimpulses (pulse frequency,duration of contraction,duration of rest, totalsession duration, differenttypes of muscle work can beimposed on the simulatedmuscles.The Compex Wireless USAmay therefore be considereda technique of muscletraining.	The Katalyst Mark 1 "isintended to stimulate healthymuscles in order to improveor facilitate muscleperformance.It is not intended to be usedin conjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind."None of the training programsor operational parameters aredesigned to target injured orailing muscles and its use onsuch muscles iscontraindicated."The Katalyst Mark 1 is Rxonly.

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Element	New Device:FastFit EMS System	Primary Predicate:Compex Wireless USA	Secondary Predicate:Katalyst Mark 1 MuscleStimulation System Model 2
		Device Features
Connection of device toelectrodes	The EMS controller isconnected via a cableelectrode harness directly tothe electrode pads.	Stimulation Module isdirectly connected to thecustom Compex femaleSNAP assembled in theelectrode.	The Katalyst Impulse Packunit is connected via a cableelectrode harness directly tothe electrodes.
Power Source	EMS Controller Module:Rechargeable 3.7[V] / ≥1800[mAh] LiPo battery	Remote: : Rechargeable3.7[V] / ≥ 1500[mAh] LiPobatteryStimulation Modules:Rechargeable 3.7[V] / ≥450[mAh] LiPo battery	Li-Po rechargeable battery3.8V, 7.79Wh(2050mAh)
Charging System	AC/DC 5[v] 2.0 [A];Distributed through dockingstation	AC/DC 5[v] 3.5[A];Distributed through dockingstation to remote and 4modules	AC/DC wall plug in,distributed directly to thedevice. 18.0[v], 1.33[A]
Method of line currentisolation	N/A (battery operateddevice)	N/A (battery operateddevice)	N/A (battery operated device)
Patient LeakageCurrent-Normal Condition-Single FaultCondition	N/A (battery operateddevice)	N/A (battery operateddevice)	N/A (battery operated device)
Number of OutputModes	One (NMES)	One (NMES)	One
Number of OutputChannels-Synchronous oralternating?	10alternating(never 2 channels activatedat the same time)	4Synchronous, but never 2channels activated at thesame time	10Not publicly available
Method of ChannelIsolation	Each channel is the middleof a H-Bridge. Except whenit is activated, each channelis always in high impedancestate.	Each channel is the middleof a H-Bridge. Except whenit is activated, each channelis always in high impedancestate.	Not publicly available
Regulated Current orRegulated Voltage?	Regulated current (allchannels)	Regulated current (allchannels)	Not publicly available
Electrode Integratedinto a body suit?	Yes	No. Placement of electrodesis dictated by the operator.	Yes
Number of Electrodes	2 per channel,4 per channel on each armand on each leg;Max 20	Not publicly available	Only 2 per channel; Max 20

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Element	New Device:FastFit EMS System	Primary Predicate:Compex Wireless USA	Secondary Predicate:Katalyst Mark 1 MuscleStimulation System Model 2
Electrode LeadsCompliant with 21 CFR898?	Yes	Yes	Yes
Electrode Interface	10mm magnetic buttons	Not publicly available	4mm Standard SNAPConnector
WirelessCommunication withControl Interface	Yes. Uses Bluetooth Smart(BT LE 4.0)	Not publicly available	Yes. Uses Bluetooth Smart(BT LE 4.0)
Mobile / Form Factor	Yes (smartphone, stimdevice attached to suit, andwearable suit)	Not publicly available	Portable with difficulty, nomobile device, its intendeduse requires a Katalystcertified operator.
Channel ControlInterface	Touch user interfaceprovided by FastFitapplication on smartphone.	Not publicly available	Using rotary encoder knobsfor each channel and masterrotary encoder for allchannels
Instant Shutoff	Physical Button	Not publicly available	Physical Button
Software / Firmware /MicroprocessorControl?	Yes	Yes	Yes
Automatic OverloadTrip?	Yes	Yes	Yes
Automatic No-LoadTrip?	No	Yes	No
Automatic Shutoff?	Yes	Yes	Yes
Patient OverrideControl?	Yes	Yes	No
Interface IndicatorDisplay:-On/Off Status	Yes (on remote and moduleunits)	Yes	Yes (on Impulse Pack viaLED and in application)
-Low Battery	Yes	Yes	Yes (on Impulse Pack)
-Voltage/CurrentLevel	Yes (on smartphone)	Yes	Yes (in application)
-Charging	Yes	Yes	Yes (on Impulse Pack)
-Duration of training	Yes (on smartphone)	Yes	Yes (in application)
Timer Range in Minutes	Maximum = 120 minutes	Maximum = 48 minutes	Maximum = 20 minutes
Weight	Controller Module: 505 gEMS Suit: 695 g	Remote: 119 gStimulation Module: 2x60 gDocking Station: 800 grams	Not publicly available

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Element	New Device:FastFit EMS System	Primary Predicate:Compex Wireless USA	Secondary Predicate:Katalyst Mark 1 MuscleStimulation System Model 2
Dimensions	Controller Module:11.7x8.9x4.8 cm	Remote: 9x4.5x0.7 cmStimulation Module: 6.5x2cmDocking Station: 25x25x2cm	Not publicly available
Housing Materials andConstruction	Nylon, SpandexPolyester w/ ConductiveCoating	Not publicly available	Not publicly available
		Output Specifications
Waveform	Symmetrical Biphasic	Symmetrical Biphasic	Symmetrical Biphasic
Shape	Rectangular	Rectangular	Rectangular
Maximum OutputVoltage (±10%)	35 V @500 Ω95 V @ 2 kΩ96 V @ 10 kΩ	60 V @ 500 Ω180 V @ 2 kΩ180 V @ 10 kΩ	60 V @ 500 Ω96 V @ 2 kΩ114.2 V @ 10 kΩ
Maximum OutputCurrent (±10%)	70 mA @500 Ω47.5 mA @ 2 kΩ9.6 mA @ 10 kΩ	120 mA @ 500 Ω90 mA @ 2 kΩ18 mA @ 10 kΩ	120 mA @ 500 Ω48 mA @ 2 kΩ11 mA @ 10 kΩ
Pulse Width	300 µs	300 to 400 µs	175 µs
Frequency	84 Hz	1 to 120 Hz	85 Hz
For multiphasicwaveforms only:-Symmetrical phases?-Phase Duration(include units)(staterange, ifapplicable)(bothphases, ifasymmetrical)	Yes.Symmetrical, 300 µs	YesSymmetrical, 300 - 400 µs	YesSymmetrical, 175 µs
Net Charge [µC/Pulse]	0 [µC] @ 500ΩExcitation pulse fullycompensated	0 [µC] @ 500ΩExcitation pulse fullycompensated	0.5 [µC] @ 500ΩExcitation pulse fullycompensated
Maximum Phase Charge[µC]	21 [µC] @ 500Ω	48 [µC] @ 500Ω	21 [µC] @ 500Ω
Maximum Current(RMS) Density[mA/cm2]	0.032 mA/cm2 @ 500Ω	1.49 mA/cm2 @ 500Ω	0.788 mA/cm2 @ 500Ω
Maximum PowerDensity [mW/cm2]	1.25 mW/cm2 @ 500Ω	27.6 mW/cm2 @ 500Ω	8.16 mW/cm2 @ 500Ω

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Element	New Device:FastFit EMS System	Primary Predicate:Compex Wireless USA	Secondary Predicate:Katalyst Mark 1 MuscleStimulation System Model 2
Burst Mode	N/A	Not publicly available	N/A
ON Time	4 second intervals	Not publicly available	4 second intervals
OFF Time	4 second intervals	Not publicly available	4 second intervals

SUMMARY OF SIMILARITIES / DIFFERENCES:

The FastFit EMS system provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities in the same way as both the predicate devices. All three devices are intended to be used in addition to physical exercise to stimulate healthy muscles in order to improve or facilitate muscle performance. The same fundamental technology platform is employed by all three devices. These devices are all comprised of a set of electrodes powered by a portable battery pack that can deliver an electrical stimulation that is adjustable by the user through a wireless remote user interface. The FastFit EMS system and the Katalyst Mark I both have their electrodes integrated into a wearable body suit, whereas the Compex® Wireless USA allows for each electrode to be independently positioned at the users' discretion.

One notable difference between the FastFit EMS system and the predicate devices is that the FastFit EMS delivers EMS with a much lower maximum current density and power density. This can be accomplished because the FastFit EMS system uses a larger electrode surface area and a lower duty cycle. A lower maximum current and power density for the FastFit represents a lower risk to the user in comparison to the predicate devices.

Another notable difference is in the interface application. The FastFit EMS uses a software application that downloads onto a mobile device (such as a smartphone), whereas the Compex® Wireless uses a software application installed on a proprietary remote device and the Katalyst Mark I uses a software application on a commercially available tablet (Microsoft Surface). Although a few other minor differences exist between the subject and predicate devices (see Basis for Substantial Equivalence Table), these differences do not adversely impact the safety and effectiveness of the subject device.

SUMMARY OF NONCLINICAL TESTING:

Comprehensive design verification and validation testing was performed on the FastFit EMS system. Results from bench and animal testing demonstrated that the function, performance, and safety of the device meet its intended use. Testing performed included a combination of the following:

System Design Verification Testing ●
Software Verification and Validation ●

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Electrical Safety Testing (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-10) ●
. Electromagnetic Compatibility Testing (IEC 60601-1-2)
Biocompatibility Testing (ISO 10993-1, ISO 10993-5, and ISO 10993-10) ●
Usability/Human Factors Testing

Overall, testing confirmed that the FastFit EMS system can be used according to its intended use and in an equivalent manner to the predicate device.

CONCLUSION:

The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues. Based on the above information. FastFit believes that the substantial equivalence of the FastFit EMS system to the Compex Wireless USA and Katalyst Mark 1 has been demonstrated.

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).