Who is the manufacturer of FIREFLY?

Firstkind Limited filed the 510(k) submission for FIREFLY (K134001).

What is the FDA product code for FIREFLY?

NGX. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for FIREFLY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FIREFLY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FIREFLY

K134001 · Firstkind Limited · NGX · May 15, 2014 · Physical Medicine

Device Facts

Record ID	K134001
Device Name	FIREFLY
Applicant	Firstkind Limited
Product Code	NGX · Physical Medicine
Decision Date	May 15, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2

Intended 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.

Device Story

Disposable, integrated neuromuscular stimulator; applies electrical pulses to common peroneal nerve behind knee to induce calf muscle contraction; increases blood flow. Device consists of constant current pulse generator, battery, and silver electrode with hydrogel coating. Operated by single button for On/Off and intensity (7 pulse width settings). Used in home or athletic facilities by athletes/users. Output is asymmetric biphasic waveform (1 Hz frequency); mimics cadence/energy of walking. Healthcare providers/users monitor intensity via flashing LED. Benefits include improved muscle performance and reduced post-exercise muscle soreness.

Clinical Evidence

Clinical evidence includes literature (Tucker et al. 2010) and two independent studies (Warwick et al. 2013; Jawad et al.) demonstrating significant increases in venous volume flow, blood flow velocity, and microcirculatory flux in healthy volunteers. A study by Ferguson et al. (n=21 healthy males) compared the device to compression socks and passive recovery, showing significantly lower perceived muscle soreness at 24 and 48 hours post-exercise for the firefly™ T-1 group.

Technological Characteristics

Disposable, integrated neuromuscular stimulator. Materials: over-molded plastic casing, silver electrode with hydrogel (ISO 10993-1 compliant). Energy: CR2032 primary lithium coin cell. Waveform: Asymmetric biphasic, constant current, 1 Hz frequency, 7 pulse width settings (70-560 µs). Dimensions: 6" x 1.6" x 0.43". Connectivity: None. Software: Embedded, microprocessor-controlled, moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.

Indications for Use

Indicated for stimulation of healthy muscles in healthy individuals to improve or facilitate muscle performance. Not for use in therapy or treatment of medical diseases or conditions. Contraindicated for individuals with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices.

Regulatory Classification

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.

Predicate Devices

Compex® Sport Plus (K083140)

Related Devices

K201131 — firefly T-2 · Firstkind Limited · May 28, 2020
K160299 — geko(TM) Plus R-2 Neuromuscular Stimulator · Firstkind Limited · Apr 8, 2016
K141919 — VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR · Ad Rem Technology Sarl · Jun 16, 2015
K152677 — geko T-2 Neuromuscular Stimulator · Firstkind Limited · Oct 23, 2015
K212762 — geko W-2 · Firstkind Limited · Nov 29, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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: 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ ## H. Technical Comparison with the Predicate Device and Discussion of Differences | Parameter | firefly™ T-1 | Compex® Sport Plus (K083140) | Substantial Equivalence | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use and Indications for Use | 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. | Intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Compex® Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated. | Same | | Use environment | Over-the-counter (non- prescription) use in athletic training facilities or the home. | Over-the-counter (non- prescription) use in athletic training facilities or the home. | Same. Both devices are for OTC use by athletes. | | Anatomical Sites | The firefly™ T-1 with the embedded electrodes is applied to the posterior aspect of the knee only for stimulation of the peroneal nerve. | Electrodes can be applied to multiple . anatomical sites, including the posterior aspect of the knee only for stimulation of the peroneal nerve. | Substantially equivalent. Both devices can be used for stimulation of the peroneal nerve. | | Stimulator Parameters | | | | | Power source -Method of Line | One CR2032 primary lithium coin cell. Not replaceable by user | Battery NIMH, rechargeable | Substantially equivalent. Both devices are battery powered. | | Current Isolation | N/A | N/A | | | -Patient Leakage Current -Normal | < 20 μΑ | Unknown . | Unable to compare. Leakage current of firefly™ T-1 is | | Parameter | firefly™ T-1 | Compex® Sport Plus (K083140) | Substantial Equivalence | | Condition -Single Fault Condition | < 20 μΑ | Unknown | extremely low and meets safety standards. | | Avg DC current through electrodes when device is on but no pulses are being applied | 0 μΑ | Unknown | Substantially equivalent or better | | Number of output modes | Single mode with seven discrete stimulation settings corresponding to the seven pulse widths. | Nine output modes | Substantially equivalent to "Active Recovery" and "Recovery Plus" modes of predicate. | | Number of output channels / synchronous or alternating? | Single channel N/A | Four channels Synchronous with 2 msec delay between channels | Substantially equivalent. Firefly™ T-1 only needs one channel for the single operating mode. | | -Method of channel isolation | N/A (single channel) | Unknown | Substantially equivalent. No channel isolation needed for firefly™ T-1. | | Regulated current or regulated voltage | Current | Unknown | Substantially equivalent. Firefly ™ T-1 complies with applicable electrical safety standards. | | Microprocessor controlled? | Yes | Yes | Same | | Automatic overload trip | Yes | Yes | Same | | Automatic no- load trip | Yes | Yes | Same | | Automatic shut- off | Yes | Yes | Same | | User over-ride control | Yes | Yes | Same | | Parameter | firefly™ T-1 | Compex® Sport Plus (K083140) | Substantial Equivalence | | Indicator display: | | | | | - On/Off status | Yes | Yes | Same | | - Low battery | Yes (device switches off) | Yes | Same | | -Voltage / current level | N/A (device has fixed constant current). Stimulus level is indicated by flashing LED. | Yes | Substantially equivalent. Both devices provide visible indication of stimulus level. | | Timer range in minutes | 1800 minutes maximum (device is disabled after 30 hours battery run time) | Active Recovery mode: 23 minute cycle Recovery Plus mode: 25 minute cycle | Substantially equivalent. Both devices can be used for extended periods. | | Compliance with voluntary standards | Yes IEC 60601-1:1998 A1, A2 IEC 60601-2-10:1987, A1 EN 60601-1-2:2007 ISO 10993-1 | Yes IEC 60601-1 IEC 60601-2-10 IEC 60601-1-2 | Substantially equivalent | | Compliance with 21 CFR 898 | N/A (electrodes are integral with the device, there are no separate leads) | Unknown | Not applicable to firefly™ T-1 | | Weight | 0.64 oz (18 g) | 12.5 oz (350 g) | Substantially equivalent. Both devices are small and lightweight. | | Dimensions | 6" x 1.6" x 0.43" | 5.6" x 1.5" x 3.9" | Substantially equivalent | | Housing material and construction | Plastic injection molding | Plastic injection molding | Substantially equivalent | | Parameter | firefly™ T-1 | Compex® Sport Plus (K083140) | Substantial Equivalence | | Waveform Parameters | | | | | Waveform - Pulsed monophasic or biphasic - Shape | Biphasic (asymmetrical biphasic with zero net DC) Rectangular, with charge balancing second phase | Biphasic Rectangular | Same Same | | Maximum output voltage (± 15%) | 13.5 V @ 500 Ω 54 V @ 2 kΩ 110 V @ 10 k Ω | 58 V @ 500 Ω 136 V @ 2 kΩ 137 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 Ω 27 mA @ 2 kΩ 11 mA @ 10 kΩ | 120 mA @ 500 Ω 68 mA @ 2 kΩ 13.7 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 Hz Recovery 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) | Substantial Equivalence | | For interferential modes only: -Beat Frequency (Hz) | N/A | N/A | Same | | For multiphasic waveforms only -Symmetrical phases -Phase duration(s) | No 70-560 μs for positive phase, second (negative) phase is an exponential decay with a 0.1 s time constant. | Yes 200 μs for positive phase 200 μs for negative phase | Both devices have zero net charge to patient. Performance testing of firefly™ T-1 demonstrates safe and effective stimulation to facilitate muscle recovery. | | Net charge -How achieved | 0 µC at 500 Ω Capacitor coupling | 0 µC at 500 Ω Unknown | Same Both devices have zero net charge. | | Maximum phase charge (@500Ω) | 18.3 µC | 96 µC | Lower phase charge for firefly™ T-1 | | Maximum rms current density (@500Ω) | 0.169 mA/cm2 rms | Active Recovery: 0.29 mA/cm2 rms Recovery Plus: 0.24 mA/cm2 rms | Lower current density for firefly™ T-1 | | Maximum avg current (average absolute value) (@500Ω) | 0.037 mA | Active Recovery: 0.43 mA Recovery Plus: 0.29 mA | Lower max average current for firefly™ T-1 | | Maximum avg power density (using smallest electrodes) (@500Ω) | 0.000044 W/cm2 | Active Recovery: 0.00104 W/cm2 Recovery Plus: 0.00069 W/cm2 | Lower power density for firefly™ T-1 | | Burst mode | N/A, single pulse, no burst mode | N/A, single pulse, no burst mode | Same | | ON Time (seconds) / OFF Time (seconds) | N/A (single pulse delivered at 1 Hz continuously while device is powered on) | N/A (selected program delivered continuously while device is powered on) | Same | | Parameter | firefly™ T-1 | Compex® Sport Plus (K083140) | Substantial Equivalence | | Electrodes | Integrated within the device. Hydrogel applied to silver electrode. Biocompatibility for the hydrogel has been established. | Provided with four large and four small self- adhesive electrodes | Substantially equivalent. Both comply with FDA recognized standards. | | Cables/ connectors | Integrated device: no separate cables | Separate electrode cables, color coded for the four channels: channel 1 = blue channel 2 = green channel 3 = yellow channel 4 = red | Separate cables not needed for firefly™ T-1 | {3}------------------------------------------------ . {4}------------------------------------------------ . - · · : {5}------------------------------------------------ · . . . {6}------------------------------------------------ . . {7}------------------------------------------------ #### 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ ## 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. {11}------------------------------------------------ #### 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 {12}------------------------------------------------ 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 {13}------------------------------------------------ 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) 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. 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. {14}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services . Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FIREFLY

Device Facts

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Device Story

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