The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical conditions of any kind.

Device Description

The firefly™ T-1 device is a disposable, fully integrated neuromuscular stimulator for muscle conditioning composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The firefly™ T-1 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the firefly™ T-1 device, based on the provided 510(k) summary:

This device is a Powered Muscle Stimulator, which typically focuses on performance characteristics rather than diagnostic accuracy like AI-powered imaging devices. Therefore, the traditional metrics of sensitivity, specificity, AUC, and multi-reader multi-case studies are not applicable in this context. Instead, the acceptance criteria relate to its functionality, safety, and effectiveness in stimulating muscles as intended.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a powered muscle stimulator, acceptance criteria are generally based on meeting industry standards for electrical safety, biocompatibility, and demonstrating the intended physiological effect. The document focuses on demonstrating substantial equivalence to a predicate device and proving its safety and effectiveness through non-clinical and limited clinical studies.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (firefly™ T-1)
Electrical Safety	IEC 60601-1	Complies
	IEC 60601-2-10	Complies
	IEC 60601-1-2 (EMC)	Complies
Biocompatibility	ISO 10993-1	All tests (cytotoxicity, dermal sensitization, dermal irritation, repeat dermal irritation) passed for hydrogel skin-contacting material, suitable for prolonged (up to 30 days) contact.
Software Verification	Moderate level of concern	All software requirement specifications met, all software hazards mitigated to risk level 1 (Accept).
Output Waveform	Net charge	0 at all intensity settings (demonstrated via oscilloscope tracings).
Intensity Levels	7 discrete levels (pulse widths 70us to 560us)	Device provides these 7 levels, allowing user control within comfort zone.
Shelf Life	24 months (labeled)	Fully operational after 27 months of accelerated aging at 30°C.
Physiological Effect (Muscle Conditioning)	Significant increase in venous volume flow, blood flow velocity, microcirculatory flux (compared to control).	Tucker et al. study: Significant increases (p<0.01) shown for 1 Hz stimulation in stimulated leg vs. non-stimulated cotrol. Warwick et al. & Jawad et al. studies: Demonstrated significant increases in blood flow with no safety concerns. Ferguson et al. study: Significantly lower perceived muscle soreness at 24 and 48 hours post-exercise compared to control groups.
User Comfort/Tolerance	Well-tolerated stimulus	Tucker et al. study showed 1 Hz frequency was well tolerated by all subjects, unlike higher frequencies.

2. Sample Size Used for the Test Set and Data Provenance

Since this is not an AI/algorithm-only diagnostic device, the concept of a single "test set" for performance metrics like sensitivity/specificity doesn't apply directly. Instead, studies involved human subjects for physiological and subjective outcomes.

Tucker et al.: The sample size is not explicitly stated in the summary, but it refers to "subjects." Data provenance is likely prospective clinical study.
Warwick et al.: The sample size is not explicitly stated in the summary, but it involved "healthy volunteers." Data provenance is likely prospective clinical study.
Jawad et al.: The sample size is not explicitly stated in the summary, but it involved "healthy subjects." Data provenance is likely prospective clinical study.
Ferguson et al.: 21 healthy males. Data provenance is likely a prospective clinical study.

The specific country of origin for these studies is not provided in the 510(k) summary, but given the submitter's address (UK), it's plausible they were conducted in the UK or internationally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For medical devices that do not involve interpretation (like diagnostic imaging), the concept of "ground truth" established by experts in the typical sense does not apply. Instead, the studies measure objective physiological parameters (blood flow, muscle soreness scores) and subjective experiences (comfort levels). The researchers conducting these studies are the "experts" in their respective fields (e.g., physiology, sports medicine) who designed the studies, collected data, and analyzed results. Their qualifications are inherent in their authorship of scientific publications.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret data to resolve discrepancies and establish a consensus ground truth. This is not applicable to the firefly™ T-1 device, as its studies involve direct physiological measurements or subjective reports from participants, not interpretive tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to diagnostic tasks involving human interpretation of medical images or data. The firefly™ T-1 is a therapeutic/performance-enhancing device.

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

This question is not applicable. The firefly™ T-1 is a medical device that directly interacts with the human body through electrical stimulation. Its performance is always "human-in-the-loop" in the sense that it is applied to a human subject. There is no independent "algorithm-only" performance to assess outside of its intended use on a person. Electrical safety and engineering bench testing could be considered "standalone" in a technical sense, but they assess instrumental characteristics, not clinical performance.

7. The Type of Ground Truth Used

The ground truth or outcome measures used in the studies were:

Physiological Measurements:
- Venous volume flow
- Blood flow velocity
- Microcirculatory flux
Subjective Outcomes:
- Perceived muscle soreness (measured using a scoring scale)
- Comfort level (verbal rating scale)
Safety Outcomes:
- Monitorization for adverse events or safety concerns.

These directly measured or reported outcomes served as the "ground truth" for the device's performance in achieving its intended effects.

8. The Sample Size for the Training Set

This concept is not applicable to the firefly™ T-1 device. "Training set" refers to data used to develop and optimize an algorithm, typically in machine learning or AI applications. The firefly™ T-1 is a hardware-based electrical stimulator with embedded software, not an AI or machine learning model that requires a training set. Its design is based on established biomedical engineering principles and physiological understanding of neuromuscular stimulation.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" and associated ground truth establishment is not relevant for this type of medical device. The device's design and parameters (like the 1 Hz frequency) were informed by prior scientific research into effective and tolerable neuromuscular stimulation to promote blood flow (e.g., the early work of Tucker et al.) rather than being 'trained' on a dataset.

Summary

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KJ34001 Page 1 of 11

510(k) Summary

MAY 1 5 2014

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

A. Submitter: Firstkind Limited Hawk House, Peregrine Business Park High Wycombe, UK HP13 7DL

Contact: Rachel Fallon Chief Technology Officer Tel: +44 (0) 1494 572045 rachel.fallon@firstkindmedical.com Email:

B. Date Prepared: May 9, 2014

Device Name and Classification Information: ﻥ

Trade Name:	firefly™ T-1
Common Name:	Powered Muscle Stimulator for Muscle Conditioning
Classification:	21 CFR 890.5850, Class II
Product Code:	NGX
Panel:	89, Physical Medicine

Predicate Device: Compex® Sport Plus (K083140) D.

E. Device Description:

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The firefly™ T-1 stimulus intensity varies with the pulse width, which can be set to one of seven levels to produce the appropriate muscle contraction within the user comfort zone (70us, 100us, 140us, 200us, 280µs, 400µs, and 560us). The asymmetric biphasic waveform results in a net charge of zero to the user during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.

Electrical contact is made with the user through a hydrogel layer applied during manufacture to the integrated electrode. The firefly™ T-1 skin contacting materials have been tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.

An optional firefly™ T-1 strap can be purchased separately and secured over the firefly™ T-1 to assure good electrode contact even for active users. The strap is made of soft neoprene sponge with a nylon cover.

F. Indications for Use:

The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly " T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

G. Contraindications

This device should not be used by anyone with a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

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H. Technical Comparison with the Predicate Device and Discussion of Differences

Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
Intended Use andIndications forUse	Intended for thestimulation of healthymuscles in order toimprove or facilitatemuscle performance.The firefly T-1 device isnot intended to be usedin conjunction withtherapy or treatmentdiseases of medical ormedical conditions ofany kind.	Intended to stimulatehealthy muscles in orderto improve or facilitatemuscle performance.Compex® Sport is notintended to be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.None of the Compex®Sport training programsare designed for injuredor ailing muscles and itsuse on such muscles iscontraindicated.	Same
Use environment	Over-the-counter (non-prescription) use inathletic training facilitiesor the home.	Over-the-counter (non-prescription) use inathletic training facilitiesor the home.	Same. Both devicesare for OTC use byathletes.
Anatomical Sites	The firefly™ T-1 with theembedded electrodes isapplied to the posterioraspect of the knee onlyfor stimulation of theperoneal nerve.	Electrodes can beapplied to multiple .anatomical sites,including the posterioraspect of the knee onlyfor stimulation of theperoneal nerve.	Substantiallyequivalent. Bothdevices can be usedfor stimulation of theperoneal nerve.
Stimulator Parameters
Power source-Method of Line	One CR2032 primarylithium coin cell. Notreplaceable by user	BatteryNIMH, rechargeable	Substantiallyequivalent. Bothdevices are batterypowered.
Current Isolation	N/A	N/A
-Patient LeakageCurrent-Normal	< 20 μΑ	Unknown .	Unable to compare.Leakage current offirefly™ T-1 is
Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
Condition-Single FaultCondition	< 20 μΑ	Unknown	extremely low andmeets safetystandards.
Avg DC currentthroughelectrodes whendevice is on butno pulses arebeing applied	0 μΑ	Unknown	Substantiallyequivalent or better
Number of outputmodes	Single mode with sevendiscrete stimulationsettings correspondingto the seven pulsewidths.	Nine output modes	Substantiallyequivalent to "ActiveRecovery" and"Recovery Plus" modesof predicate.
Number of outputchannels /synchronous oralternating?	Single channelN/A	Four channelsSynchronous with 2msec delay betweenchannels	Substantiallyequivalent. Firefly™T-1 only needs onechannel for the singleoperating mode.
-Method ofchannel isolation	N/A (single channel)	Unknown	Substantiallyequivalent. No channelisolation needed forfirefly™ T-1.
Regulatedcurrent orregulated voltage	Current	Unknown	Substantiallyequivalent. Firefly ™T-1 complies withapplicable electricalsafety standards.
Microprocessorcontrolled?	Yes	Yes	Same
Automaticoverload trip	Yes	Yes	Same
Automatic no-load trip	Yes	Yes	Same
Automatic shut-off	Yes	Yes	Same
User over-ridecontrol	Yes	Yes	Same
Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
Indicator display:
- On/Off status	Yes	Yes	Same
- Low battery	Yes (device switchesoff)	Yes	Same
-Voltage /current level	N/A (device has fixedconstant current).Stimulus level isindicated by flashingLED.	Yes	Substantiallyequivalent. Bothdevices provide visibleindication of stimuluslevel.
Timer range inminutes	1800 minutes maximum(device is disabled after30 hours battery runtime)	Active Recovery mode:23 minute cycleRecovery Plus mode: 25minute cycle	Substantiallyequivalent. Bothdevices can be usedfor extended periods.
Compliance withvoluntarystandards	YesIEC 60601-1:1998 A1,A2IEC 60601-2-10:1987,A1EN 60601-1-2:2007ISO 10993-1	YesIEC 60601-1IEC 60601-2-10IEC 60601-1-2	Substantiallyequivalent
Compliance with21 CFR 898	N/A (electrodes areintegral with the device,there are no separateleads)	Unknown	Not applicable tofirefly™ T-1
Weight	0.64 oz (18 g)	12.5 oz (350 g)	Substantiallyequivalent. Bothdevices are small andlightweight.
Dimensions	6" x 1.6" x 0.43"	5.6" x 1.5" x 3.9"	Substantiallyequivalent
Housing materialand construction	Plastic injection molding	Plastic injection molding	Substantiallyequivalent
Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
Waveform Parameters
Waveform- Pulsed monophasic or biphasic- Shape	Biphasic (asymmetrical biphasic with zero net DC)Rectangular, with charge balancing second phase	BiphasicRectangular	SameSame
Maximum output voltage (± 15%)	13.5 V @ 500 Ω54 V @ 2 kΩ110 V @ 10 k Ω	58 V @ 500 Ω136 V @ 2 kΩ137 V @ 10 k Ω	Firefly™ T-1 operates at lower voltages.Performance testing demonstrates safe and effective stimulation to facilitate muscle recovery.
Maximum output current (± 15%)	27 mA @ 500 Ω27 mA @ 2 kΩ11 mA @ 10 kΩ	120 mA @ 500 Ω68 mA @ 2 kΩ13.7 mA @ 10 kΩ	Firefly™ T-1 operates at lower currents.Performance testing demonstrates safe and effective stimulation to facilitate muscle recovery.
Pulse widths	70, 100, 140, 200, 280, 400, 560 μs	400 μs total (200 μs per phase)	Firefly™ T-1 offers a wider range of pulse widths. Users can choose the stimulus level needed for muscle twitch.
Frequency	1 Hz	Active Recovery:frequency cycles in preset pattern between 1 Hz and 9 HzRecovery Plus:frequency cycles in preset pattern between 1 Hz and 6 Hz	Firefly™ T-1 pulse is fixed at 1 Hz while predicate programs run through the range of low frequencies shown.Performance testing of firefly™ T-1 demonstrates safe and effective stimulation to facilitate muscle recovery.
Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
For interferentialmodes only:-Beat Frequency(Hz)	N/A	N/A	Same
For multiphasicwaveforms only-Symmetricalphases-Phaseduration(s)	No70-560 μs for positivephase, second(negative) phase is anexponential decay with a0.1 s time constant.	Yes200 μs for positivephase200 μs for negativephase	Both devices have zeronet charge to patient.Performance testing offirefly™ T-1demonstrates safe andeffective stimulation tofacilitate musclerecovery.
Net charge-How achieved	0 µC at 500 ΩCapacitor coupling	0 µC at 500 ΩUnknown	SameBoth devices have zeronet charge.
Maximum phasecharge (@500Ω)	18.3 µC	96 µC	Lower phase chargefor firefly™ T-1
Maximum rmscurrent density(@500Ω)	0.169 mA/cm2 rms	Active Recovery:0.29 mA/cm2 rmsRecovery Plus:0.24 mA/cm2 rms	Lower current densityfor firefly™ T-1
Maximum avgcurrent (averageabsolute value)(@500Ω)	0.037 mA	Active Recovery:0.43 mARecovery Plus:0.29 mA	Lower max averagecurrent for firefly™ T-1
Maximum avgpower density(using smallestelectrodes)(@500Ω)	0.000044 W/cm2	Active Recovery:0.00104 W/cm2Recovery Plus:0.00069 W/cm2	Lower power densityfor firefly™ T-1
Burst mode	N/A, single pulse, noburst mode	N/A, single pulse, noburst mode	Same
ON Time(seconds) / OFFTime (seconds)	N/A (single pulsedelivered at 1 Hzcontinuously whiledevice is powered on)	N/A (selected programdelivered continuouslywhile device is poweredon)	Same
Parameter	firefly™ T-1	Compex® Sport Plus(K083140)	SubstantialEquivalence
Electrodes	Integrated within thedevice. Hydrogel appliedto silver electrode.Biocompatibility for thehydrogel has beenestablished.	Provided with four largeand four small self-adhesive electrodes	Substantiallyequivalent. Bothcomply with FDArecognized standards.
Cables/connectors	Integrated device: noseparate cables	Separate electrodecables, color coded forthe four channels:channel 1 = bluechannel 2 = greenchannel 3 = yellowchannel 4 = red	Separate cables notneeded for firefly™ T-1

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Nonclinical Data: -

The following nonclinical testing was provided in this 510(k):

Shelf Life Testing - Real-time shelf life testing was conducted. Devices in their final packaging were stored under controlled conditions at 30°C for 27 months then subjected to full technical performance testing following 24 hours of operation. The results of this testing confirmed that the device remains fully operational in accordance with its performance specifications after 27 months of aging, and support a labelled shelf life of 24 months.

Biocompatibility Testing - The skin contacting material of the firefly™ T-1 device (hydrogel) was subjected to biocompatibility testing per ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for devices in contact with intact skin, including cytotoxicity, dermal sensitization, and dermal irritation. In view of the potential for repeated sequential use of the device, repeat dermal irritation testing was also conducted. All tests passed.

Software Verification and Validation - Software documentation consistent with a moderate level of concern was submitted in this 510(k). Latent software design flaws or faults would not be expected to result in serious user

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or patient injury. System validation testing presented in this 510(k) demonstrated that all software requirement specifications were met and all software hazards were mitigated to risk level 1 (Accept).

Electrical Safety and Electromagnetic Compatibility Testing - The firefly™ T-1 device has been certified by Intertek to comply with the applicable clauses of the following standards:

. IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; +A1:1991-11, +A2, 1995
. IEC 60601-2-10: Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators; 1987; +A1 2001
IEC 60601-1-2: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 30 edition, 2007.

Engineering Bench Testing - In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's Guidance Document for Powered Muscle Stimulator 510(k)s, Attachment II, Section 1 - Output Waveforms. Oscilloscope tracings were obtained of the device output waveforms at each pulse width (i.e., intensity settings 1 through 7) under loads of 500Ω. 2 kΩ and 10kΩ. These tracings demonstrated that the net charge in the firefly™ T-1 output waveform at all settings is 0.

J. Clinical Data

The safety and effectiveness of the firefly™ T-1 has been evaluated in independent clinical studies. The early work of Tucker et al. established that a 1 Hz frequency electrical stimulus, applied at the common peroneal nerve, resulted in significant increases (p<0.01) in venous volume flow, blood flow velocity, and microcirculatory flux in the stimulated leg as compared to the non-stimulated control leg. The changes in blood flow parameters were comparable amongst all stimulus frequencies (1 Hz to 5Hz); however, the highest amplitude/frequency programs reached a moderate discomfort level

1 Tucker AT, Maass A, Bain DS, Chen L, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol 2010; Spring 19(1): e31-7.

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on the subject verbal rating scale, while the lowest frequency of 1 Hz was well tolerated by all subjects. This work formed the basis for developing the firefly™ T-1 device.

Subsequently, two independent investigators studied the safety and efficacy of the device technology (also implemented in the geko™ T-1) for increasing blood flow. Warwick et al.2 and Jawad et al.3 both applied the device to the common peroneal nerve of healthy volunteers, setting the simulation level to elicit a palpable twitch of the foot, according to the manufacturer's instructions. In the first study, blood flow measurements were obtained with the subjects in four positions: 1) lying supine, lower limb horizontal; 2) supine, lower limb elevated at 25 to 35 degrees hip flexion; 3) standing, non weight-bearing (weight on contralateral leg only); and 4) standing, weightbearing (weight evenly distributed on both legs) both with and without a plaster cast applied. In the second study, the impact on blood flow from electrical stimulation was compared to that from intermittent pneumatic compression (IPC) devices. Both studies demonstrated significant increases in blood flow when using the firefly™T-1 electrostimulation device with no safety concerns.

A clinical study of the firefly™ T-1 conducted by Ferguson et al.4. examined the effects of the electrical stimulation alone compared to graduated compression socks alone or passive recovery (no`intervention) on muscle soreness, strength, and markers of muscle damage and inflammation following intense intermittent exercise in 21 healthy males. The study results demonstrated that athletes using the firefly™ T-1 had significantly lower scores for perceived muscle soreness at 24 and 48 hours post exercise as compared to the groups using graduated compression socks or passive recovery.

2 Warwick D. Shaikh A. Gadola S. Stokes M. Worslev P. Bain D. Tucker A. Gadola SD: Neuromuscular electrostimulation via the common peroneal nerve promotes lower limb flow in a below-knee cast: a potential thromboprophylaxis. Bone Joint Res, Sep 2013, 2(9):179-85. 3 Jawad H. Bain DS. Dawson H. Crawford K. A comparative study investigating the effectiveness of neuromuscular electrostimulation versus intermittent pneumatic compression in enhancing lower limb blood flow in healthy subjects. Submitted for publication to J Thrombosis and Haemostasis.

4 Ferguson R, Dodd M, Paley V: Neuromuscular electrical stimulation via the peroneal nerve reduces muscle soreness following intermittent exercise. Submitted for publication to Eur J Applied Physiol.

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l. Conclusions

The information and testing presented in this 510(k) demonstrates that the firefly™ T-1 device performs as designed and intended and is substantially equivalent for use as a neuromuscular stimulator for muscle conditioning.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle, represented by three curved lines that suggest the bird's wings and body.

Public Health Service

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

May 15, 2014

Firstkind Ltd c/o Sheila Hemeon-Hever Radcliffe Consulting, Inc. 231 Fairbanks Street West Boylston, MA 01583

Re: K134001

Trade/Device Name: firefly T-1 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 17, 2014 Received: April 18, 2014

Dear Ms. Hemeon-Heyer:

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

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Page 2 - Ms. Sheila Hemeon-Hever

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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" (21CFR 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/McdicalDcvices/Safety/ReportalProblem/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 yours,

Felipe Aguel -S

for

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K134001

Device Name firefly™ T-1

Indications for Use (Describe)

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

്കുകയും 2014.05.15

പ്രോമന്ത്രം 2014.05.15 16:09:31 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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.

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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).