GEKO

K133638 · Firstkind Limited · IPF · Aug 21, 2014 · Physical Medicine

Device Facts

• Record ID: K133638
• Device Name: GEKO
• Applicant: Firstkind Limited
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The geko™ T-1 Neuromuscular Stimulator is intended for: - Increasing local blood circulation, and - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

Device Story

The geko™ T-1 is a disposable, single-channel neuromuscular stimulator. It consists of a constant current pulse generator, battery, and integrated silver electrode with hydrogel, all in an over-molded plastic casing. Applied to the common peroneal nerve behind the knee, it delivers electrical pulses to induce calf muscle contraction, mimicking the cadence and energy of walking to increase blood flow. A single button controls power and intensity (seven pulse-width levels). Used in clinical or home settings, it is operated by patients or clinicians. The device provides a non-invasive method for DVT prophylaxis, offering an alternative to intermittent pneumatic compression or stockings. It benefits patients by augmenting venous and arterial blood flow, potentially reducing post-surgical thrombosis risk. The device is designed for single-patient use, with a 30-hour battery life.

Clinical Evidence

Evidence includes literature and three independent investigations. Tucker et al. established 1 Hz stimulation increases venous/arterial flow. Warwick et al. (10 healthy volunteers) showed significant peak venous velocity increases (p<0.05) with geko™ in various postures and under plaster casts. Jawad et al. (10 healthy volunteers) reported geko™ significantly outperformed (p<0.001) two intermittent pneumatic compression devices in blood flow metrics. A study of 40 total hip replacement patients showed geko™ significantly increased venous blood velocity compared to no treatment and Thromboembolism Deterrent Stockings (TEDS), with no device-related adverse events.

Technological Characteristics

Disposable, single-channel neuromuscular stimulator. Materials: plastic housing, silver electrode with hydrogel (ISO 10993-1 compliant). Energy: 3V CR2032 lithium coin cell. Waveform: Asymmetric biphasic, 1 Hz frequency, 70-560 µs pulse width. Connectivity: None. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Software: Microprocessor-controlled, moderate level of concern.

Indications for Use

Indicated for increasing local blood circulation and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Contraindicated for patients with cardiac demand pacemakers or recently diagnosed deep vein thrombosis.

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

• SYS*STIM ME 208 (K031017)

Submission Summary (Full Text)

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

August 21, 2014

Firstkind Limited c/o Sheila Hemeon-Heyer, JD, RAC Radcliffe Consulting, Inc. 231 Fairbanks Street West Boylston, MA 01583

Re: K133638

Trade/Device Name: geko™ T-1 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: July 25, 2014 Received: July 25, 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 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

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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 [phone] or [phone] 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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Felipe Aquel -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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#### Indications for Use

510(k) Number (if known) K133638

Device Name geko™ T-1 Neuromuscular Stimulator

#### Indications for Use (Describe)

The geko™ T-1 Neuromuscular Stimulator is intended for:

- Increasing local blood circulation, and

- Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

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)

#### 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)

# te: 2014.08.21 32 -04'00'

FORM FDA 3881 (9/13)

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# 510(k) Summary

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<br>Hawk House<br>Peregrine Business Park<br>High Wycombe, UK<br>HP13 7DL |
|----|------------|--------------------------------------------------------------------------------------------|
|----|------------|--------------------------------------------------------------------------------------------|

Contact: Rachel Fallon Chief Technology Officer

[phone] Tel: Email: [e-mail]

#### B. Date Prepared: July 25, 2014

### C. Device Name and Classification Information:

| Trade Name: | geko™ T-1 Neuromuscular Stimulator (geko) |
|----------------------|-------------------------------------------|
| Common/usual Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |

- SYS*STIM ME 208 (K031017) D. Predicate Device:
#### Device Description: ய்

The qeko™ T-1 (qeko™) Neuromuscular Stimulator is a disposable, fully integrated unit 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 geko™ is applied so that the electrodes lie over the common peroneal nerve behind

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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.

The geko stimulus intensity varies with the pulse width, which can be set to one of seven levels to produce the appropriate muscle contraction within the patient comfort zone (70μs, 100μs, 140μs, 200μs, 400μs, and 560μs). The asymmetric biphasic waveform results in a net charge of zero to the patient 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 patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient 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.

## F. Indications for Use:

The geko™ T-1 device is a Neuromuscular Stimulator and is intended for:

- Increasing local blood circulation, and .
- Immediate post-surgical stimulation of the calf muscles to prevent ● venous thrombosis.

# G. Contraindications

Powered muscle stimulators should not be used on patients with cardiac demand pacemakers.

Powered muscle stimulators should not be used on patients with recently diagnosed deep vein thrombosis.

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| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>and Indications<br>for Use | The geko T-1 is a<br>neuromuscular<br>stimulation device and is<br>intended for:<br>Increasing local blood<br>circulation Immediate post-<br>surgical stimulation of<br>the calf muscles to<br>prevent venous<br>thrombosis | 1. Symptomatic relief of<br>chronic intractable pain,<br>acute post traumatic pain<br>or acute post-surgical pain<br>2. Temporary relation of<br>muscle spasm<br>3. Prevention of post-<br>surgical phlebo-<br>thrombosis through<br>immediate stimulation of<br>calf muscles<br>4. Increasing local blood<br>circulation<br>5. Prevention or<br>retardation of disuse<br>atrophy<br>6. Muscle re-education<br>7. Maintaining or<br>increasing range of motion | The indications for<br>use of the geko™ T-1<br>are a subset of the<br>indications for use of<br>the predicate device<br>(see #3 and #4 for<br>the SYS*STIM 208) |
| Clinical<br>application | Prescription use only for<br>use in a clinical or home<br>use setting.<br>Single patient use for up<br>to 30 hours (replacement<br>recommended after 24<br>hours) | Prescription use only for<br>use in a clinical or home<br>use setting.<br>The device is reusable but<br>the electrodes are single<br>use, disposable. | Substantially<br>equivalent. Both<br>devices are for<br>prescription use in a<br>clinical or home<br>environment. |
| Anatomical<br>Sites | The electrodes are<br>applied to the posterior<br>aspect of the knee only<br>for stimulation of the<br>peroneal nerve. | Electrodes can be applied<br>to multiple anatomical<br>sites, including the<br>posterior aspect of the<br>knee only for stimulation of<br>the peroneal nerve. | Substantially<br>equivalent. Both<br>devices can be used<br>for stimulation of the<br>peroneal nerve. |
| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
| Basic Unit Characteristics | | | |
| Power source | One CR2032 primary<br>lithium coin cell. Not<br>replaceable by user | Mains (line) voltage | Substantially<br>equivalent. Both<br>devices meet<br>electrical safety<br>standards. |
| -Method of Line<br>Current<br>Isolation | N/A | Transformer isolation | |
| -Patient<br>Leakage<br>Current | | | Substantially<br>equivalent. |
| -Normal<br>Condition | < 20μA | <100 μA | Leakage current of<br>geko is less than |
| -Single<br>Fault Condition | < 20μA | <300 μA | predicate device. |
| Number of<br>output modes | Single mode with seven<br>discrete stimulation<br>settings corresponding to<br>the seven pulse widths. | Three output modes<br>The "Pulse" mode has a<br>200 μs pulse width | Substantially<br>equivalent to "Pulse"<br>mode of predicate. |
| Number of<br>output<br>channels | Single channel | Single channel | Same |
| -Synchronous<br>or alternating | N/A (single channel) | N/A (single channel) | Same |
| -Method of<br>channel<br>isolation | Capacitor | Transformer | Substantially<br>equivalent. Both<br>methods are effective<br>methods of channel<br>isolation. |
| Regulated<br>current or<br>regulated<br>voltage | Current regulated | Voltage regulated | Substantially<br>equivalent. Both<br>methods comply with<br>electrical safety<br>standards. |
| Microprocessor<br>controlled? | Yes | Yes | Same |
| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
| Automatic<br>overload trip | Yes | No | Substantially<br>equivalent or better. |
| Automatic no-<br>load trip | Yes | No | Substantially<br>equivalent or better. |
| Automatic<br>shut-off | Yes | Yes | Same |
| Patient over-<br>ride control | Yes | Yes | Same |
| Indicator<br>display | | | |
| - On/Off status | Yes | Yes | Same |
| - Low battery | Yes (device switches off) | N/A | Substantially<br>equivalent |
| -Voltage /<br>current level | N/A (device has fixed<br>constant current) | Yes (intensity control) | Substantially<br>equivalent. |
| -Charge level<br>(pulse width) | Yes (pulse width varies to<br>change delivered<br>charge), The stimulation<br>level (pulse width) is<br>indicated by the flashing<br>of the LED The number<br>of times LED flashes in<br>sequence indicates the<br>level of stimulation, with<br>level 1 (a single flash)<br>equating to 70 μs being<br>the lowest stimulation<br>level and level 7 (7<br>flashes in sequence)<br>equating to 560 μs, the<br>highest. stimulation level | N/A (device has fixed<br>pulse width (200 μs)). | Substantially<br>equivalent. |
| Timer range in<br>minutes | 1800 minutes maximum<br>(device is disabled after<br>30 hours battery run time) | 60 minute timer can be<br>reset indefinitely | Substantially<br>equivalent. |
| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
| Compliance<br>with voluntary<br>standards | Yes<br>IEC 60601-1:1998 A1, A2<br>IEC 60601-2-10:1987, A1<br>EN 60601-1-2:2007<br>ISO 10993-1 | Yes<br>UL 2601-1<br>CAN/CSA-22.601.2.10-92 | Substantially<br>equivalent |
| Compliance<br>with 21 CFR<br>898 | N/A (electrodes are<br>integral with the device,<br>there are no separate<br>leads) | Yes | Substantially<br>equivalent |
| Weight | 18 g | 1.4 pounds (636g) | Substantially<br>equivalent. Both<br>devices are small<br>and lightweight. |
| Dimensions | 6" x 1.6" x 0.43" | 2.75" x 6.1" x 8" | Substantially<br>equivalent |
| Housing<br>material and<br>construction | Plastic injection molding | Plastic injection molding | Substantially<br>equivalent |
| Output Specifications | | | |
| Waveform<br>-Pulsed<br>monophasic or<br>biphasic<br>- Shape | Biphasic (asymmetrical<br>biphasic with zero net<br>DC)<br>Rectangular, with charge<br>balancing second phase | Biphasic (asymmetrical<br>biphasic with zero net DC)<br>Rectangular, with charge<br>balancing second phase | Same |
| Maximum<br>output voltage | 13.5 V @ 500 Ω<br>54 V @ 2000 Ω<br>110 V @ 10,000 Ω | 92 V @ 500 Ω (measured)<br>144 V @ 2000 Ω<br>166 V @ 10,000 Ω | Substantially<br>equivalent. Geko can<br>operate at lower<br>voltage as intensity is<br>increased by<br>increasing pulse<br>width. |
| Maximum<br>output current | 27 mA @ 500 Ω<br>27 mA @2000 Ω<br>11 mA @ 10,000 Ω | 184 mA @ 500 Ω<br>72 mA @2000 Ω<br>17 mA @ 10,000 Ω | Substantially<br>equivalent for same<br>reason as above. |
| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
| Pulse width | 70, 100, 140, 200, 280,<br>400, 560 µs | 200 µs | Substantially<br>equivalent. Predicate<br>varies intensity by<br>increasing<br>voltage/current in<br>fixed pulse width. |
| Frequency | 1 Hz | 1 to 80 Hz | Substantially<br>equivalent. Low<br>frequency used to<br>increase circulation. |
| For<br>interferential<br>modes only:<br>-beat<br>Frequency (Hz) | N/A | N/A | Same |
| Multiphasic<br>waveforms | | | |
| -Symmetrical<br>phases | No | No | Same |
| -Phase duration | 70-560 µs for positive<br>phase, second (negative)<br>phase is an exponential<br>decay with a 0.1 s time<br>constant. | 200 µs | Substantially<br>equivalent. Reasons<br>previously discussed. |
| Net charge | 0 µC at 500 Ω | ~0 µC at 100 Ω | Same |
| -How achieved | Capacitor coupling | Transformer coupling | Methods are<br>substantially<br>equivalent. |
| Maximum<br>phase charge | 18.3 µC at 500 Ω | 33.5 µC at 500 Ω | Substantially<br>equivalent or better |
| Maximum<br>current density | 6.67 mA/cm² | 9.12 mA/cm² | Substantially<br>equivalent or better. |
| Maximum<br>power density | 0.000044 W/cm² | 0.012 W/cm² | Substantially<br>equivalent or better. |
| Parameter | geko™ T-1 | SYS*STIM ME 208<br>(K031017) | Substantial<br>Equivalence |
| Burst mode<br>a) Pulses per<br>burst<br>b) Bursts per<br>second<br>c) Burst<br>duration<br>(seconds)<br>d) Duty Cycle<br>[Line (b) x<br>Line (c)] | N/A (single pulse, no<br>pulse train or burst) | N/A when used in PULSE<br>mode (single pulse) | Same. |
| ON Time<br>(seconds) | N/A Stimulation is<br>delivered at 1 Hz, with<br>single pulses of 70µs to<br>560µs | N/A Stimulation is<br>delivered at 1 Hz, with<br>single pulses of 200 µs | Same. |
| OFF Time<br>(seconds) | N/A Stimulation is<br>delivered at 1 Hz, with<br>single pulses of 70µs to<br>560µs | N/A Stimulation is<br>delivered at 1 Hz, with<br>single pulses of 200 µs | Same. |
| Additional Features | | | |
| - On/Off status | Yes | Yes | Same |
| - Low battery | Yes (device switches off) | N/A (mains powered) | Substantially<br>equivalent |
| -Voltage /<br>current level | Yes. Fixed constant<br>current (pulse width<br>varies to change<br>delivered charge) | Yes Continuously variable<br>using un-calibrated dial | Substantially<br>equivalent |
| -Low stim<br>current | Yes. Unit turns off after 4<br>minutes below low<br>current threshold…