FLEX-MT +

K140467 · Emsi · IPF · Oct 7, 2014 · Physical Medicine

Device Facts

• Record ID: K140467
• Device Name: FLEX-MT +
• Applicant: Emsi
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS- Transcutaneous Nerve Stimulation - Symptomatic relief of chronic intractable pain . . Post traumatic and post surgical pain relief EMS- Electrical Muscle Stimulation - . Relaxation of muscle spasm . . Increasing local blood circulation . . Muscle re-education . . Prevention or retardation of disuse atrophy . Prevention of venous thrombosis of the calf muscles immediately after surgery . . Maintaining or increase range of motion

Device Story

Flex-MT+ is a battery-powered, handheld combination TENS and EMS device; delivers electrical stimulation to patient skin via electrodes; 2 output channels; adjustable output and waveform; powered by 4.8V Ni-MH rechargeable battery pack. Used in clinical or home settings; operated by patient or clinician. Device includes patient compliance timer (up to 999 hours). Output parameters (voltage, current, pulse duration) are adjustable. Healthcare providers use device to manage pain and muscle function; output affects clinical decision-making by providing non-pharmacological pain relief and physical therapy support. Benefits include improved muscle function, pain reduction, and prevention of atrophy/thrombosis.

Clinical Evidence

No clinical study data provided. Substantial equivalence is based on bench testing and technical comparison to predicate devices.

Technological Characteristics

Battery-powered (4.8V Ni-MH) handheld stimulator; 2 output channels; transformer-based channel isolation; regulated voltage output; plastic housing. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, EN 60601-1-4, and EN 62304. Waveforms: Asymmetrical biphasic (TENS), Biphasic symmetrical (EMS).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-traumatic/post-surgical pain, relaxation of muscle spasms, increased local blood circulation, muscle re-education, prevention/retardation of disuse atrophy, prevention of venous thrombosis of calf muscles post-surgery, and maintenance/increase of range of motion.

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

• EMSI TENS-EMS-14 (Flex MT) (K083030)
• EMPI 300 PV (K021100)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are connected by a flowing line that forms the base of the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

October 7, 2014

EMSI % Cherita James M Squared Associates, Inc. 815 King St. Suite 206 Alexandria, VA 22314

Re: K140467

Trade/Device Name: Flex-MT+ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: August 20, 2014 Received: August 22, 2014

Dear Ms. James:

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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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 (OS) 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

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

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# Indications for Use

510(k) Number (if known) K140467

Device Name Flex-MT +

Indications for Use (Describe)

TENS - Transcutaneous Nerve Stimulation

- · Symptomatic relief of chronic intractable pain
· Post traumatic and post surgical pain relief

EMS - Electrical Muscle Stimulation

- · Relaxation of muscle spasm
- Increasing local blood circulation
- · Muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining or increase range of motion

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

| <div> <span></span>Registration Use (Part 21 CFR 201.Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 201.Subpart C) </div> |
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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY

The following information is provided as required by 21 CFR § 807.92 for EMSI's Flex-MT + 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

- Sponsor: EMSI 3504 Cragmont Dr. Suite#100 Tampa, Florida 33619 Ph: 813-471-0129 Fax: [phone] Registration Number: 3003573572
M Squared Associates, Inc. Contact: Cherita James 815 King Street, Suite 206 Alexandria, VA 22314 Ph. 703-562-9800 Ext 257 Fax. [phone]

| Date of Submission: | September 30, 2014 |
|----------------------|------------------------------------------------------------|
| Proprietary Name: | Flex-MT + |
| Common Name: | Powered Muscle Stimulator, Transcutaneous Nerve Stimulator |
| Regulatory Class: | II |
| Regulation: | 21 CFR 890.5850, 21 CFR 882.5890 |
| Panel: | Physical Medicine |
| Product Codes: | IPF, GZJ |
| Predicate Device(s): | K083030 EMSI TENS-EMS-14 (Flex MT), K021100 EMPI 300 PV |

The Flex-MT + is a combination TENS and EMS device which delivers Device Description: nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni

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MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

Intended Use: As prescribed by a physician for the following:

#### TENS- Transcutaneous Nerve Stimulation

- Symptomatic relief of chronic intractable pain .
- . Post traumatic and post surgical pain relief

### EMS- Electrical Muscle Stimulation

- . Relaxation of muscle spasm
- . Increasing local blood circulation
- . Muscle re-education
- . Prevention or retardation of disuse atrophy
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- . Maintaining or increase range of motion

### Performance Testing

The Flex-MT + is compliant with the following standards and has outputs which are within the same range as the predicate devices.

- . IEC 60601-1:2005 = Corr 1:2006, Corr 2:2007 Medical Electrical Equipment - Part 1: General Requirements For Safety
- . IEC 60601-1-2:2007/AC:2010 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -Requirements And Test
- IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements . for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- EN 60601-1-4:1996+A1:1999 Medical device Programmable Electrical Medical Systems (PEMS);
- . EN 62304 : 2006/AC:2008 Medical device software-Software life cycle processes.

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## Technical and Performance Comparison

Both the subject device and the predicate device are battery powered, handheld devices with similar unit characteristics including device controls, power supply, output modes and channels, waveforms, output voltage, current and pulse durations, as well as device material.

| | Subject Device<br>Flex-MT + | Predicate K08303<br>EMSI TENS-<br>EMS-14(Flex MT) | Predicate<br>K021100<br>EMPI 300PV<br>(TENS/NMES<br>modes) | Comment |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Indication for Use | TENS-<br>Transcutaneous<br>Nerve Stimulation<br>•Symptomatic<br>relief of chronic<br>intractable pain<br>•Post traumatic<br>and post surgical<br>pain relief<br><br>EMS- Electrical<br>Muscle<br>Stimulation<br>•Relaxation of<br>muscle spasm<br>•Increasing local<br>blood circulation<br>•Muscle re-<br>education<br>•Prevention or<br>retardation of<br>disuse atrophy<br>•Prevention of<br>venous<br>thrombosis of the<br>calf muscles<br>immediately after<br>surgery<br>•Maintaining or<br>increase range of<br>motion | TENS-<br>Transcutaneous<br>Nerve Stimulation<br>•Symptomatic<br>relief of chronic<br>intractable pain<br>•Post traumatic and<br>post surgical pain<br>relief<br><br>EMS- Electrical<br>Muscle Stimulation<br>•Relaxation of<br>muscle spasm<br>•Increasing local<br>blood circulation<br>•Muscle re-<br>education<br>•Prevention or<br>retardation of<br>disuse atrophy<br>•Prevention of<br>venous thrombosis<br>of the calf muscles<br>immediately after<br>surgery<br>•Maintaining or<br>increase range of<br>motion | TENS-<br>Transcutaneous<br>Nerve Stimulation<br>•Symptomatic<br>relief of chronic<br>intractable pain<br>•Adjunctive<br>treatment for post<br>surgical and post<br>trauma pain<br><br>EMS- Electrical<br>Muscle Stimulation<br>•Relaxation of<br>muscle spasm<br>•Increasing local<br>blood circulation<br>• Re-education<br>muscles<br>• Retarding or<br>preventing disuse<br>atrophy<br>•Prevention of<br>venous thrombosis<br>of the calf muscles<br>immediately after<br>surgery<br>•Maintaining or<br>increase range of<br>motion | Same indications<br>in the subject and<br>predicates TENS<br>and NMES modes. |

| | Subject Device<br>Flex-MT + | Predicate K08303<br>EMSI TENS-<br>EMS-14(Flex<br>MT) | Predicate<br>K021100<br>EMPI 300PV | Comment |
|------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Power Source | 700 mAh 4.8V<br>Ni-MH,<br>rechargeable | four batteries, size<br>AA, alkaline | Two batteries, size<br>AA rechargeable,<br>and charger | All devices are<br>battery operated.<br>The subject and |
| | Subject Device<br>Flex-MT + | Predicate K08303<br>EMSI TENS-<br>EMS-14(Flex<br>MT) | Predicate<br>K021100<br>EMPI 300PV | Comment |
| | battery pack and<br>charger | | | EMPI devices<br>offer a battery<br>charger. |
| – Method<br>of Line Current<br>Isolation | n/a | n/a | n/a | NA |
| - Patient<br>Leakage Current<br>- Normal condition<br>- Single<br>fault condition | not measurable<br>< 1 microamp | not measurable<br>< 1 microamp | Unknown | The subject and<br>EMSI predicate<br>have the same<br>Patient Leakage<br>level |
| 5. Number of<br>Output Modes | 2 | 2 | 4 | The subject and<br>EMSI predicate<br>have the same<br>number of<br>channels. The<br>EMPI predicates<br>offers the same 2<br>channels, as well<br>as 2 additional<br>channels for their<br>IFS and FES<br>outputs. |
| 6. Number of<br>Output Channels | 2 | 2 | 2 | Same number and<br>type of output<br>channels and<br>channel isolation. |
| - Synchronous<br>or Alternating | Synchronous or<br>Alternating | Synchronous or<br>Alternating | Synchronous or<br>Alternating | |
| – Method of<br>Channel Isolation | Transformer | Transformer | Transformer | |
| 7. Regulated<br>Current or<br>Regulated Voltage? | Regulated<br>Voltage | Regulated voltage | Unknown | Same regulated<br>voltage method as<br>the EMSI predicate<br>device. |
| 8.<br>Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | All devices are<br>software controlled |
| 9. Automatic<br>Overload Trip? | Yes | No | Unknown | The automatic<br>overload<br>protection<br>provides additional<br>safety when<br>operating the<br>subject device |
| Subject Device<br>Flex-MT + | Predicate K08303<br>EMSI TENS-<br>EMS-14(Flex<br>MT) | Predicate<br>K021100<br>EMPI 300PV | Comment | |
| 11. Automatic Shut<br>Off? | Yes | Yes | Yes | Same features |
| 12. Patient<br>Override Control? | Yes | Yes | Yes | Same features |
| 13. Indicator<br>Display:<br>On/Off Status?<br>Low Battery?<br>Voltage/Current<br>Level? | Yes<br>Yes<br>Yes (1-10 bars<br>displayed) | Yes<br>Yes<br>Yes (1-10 bars<br>displayed) | Yes<br>Yes<br>Yes | Same features |
| 4. Timer Range<br>(minutes) | 5-90 minutes, or<br>continuous | 5-90 minutes, or<br>continuous | 5-99 minutes, or<br>continuous | Minor timer<br>difference when<br>compared to the<br>EMPI predicate do<br>not affect safety or<br>effectiveness. |
| 15. Compliance<br>with Voluntary<br>Standards? | ANSI/AAMI<br>ES1-1993<br>IEC 60601-1-2 as<br>applicable | ANSI/AAMI ES1-<br>1993<br>IEC 60601-1-2 as<br>applicable | Unknown | NA |
| 16. Compliance<br>with 21 CFR 898? | Yes | Yes | Yes | Same features |
| 17. Weight | 156 g (including<br>battery) | 140 g | 226g | Minor differences<br>in weight and |
| 18. Dimensions [W<br>x H x D] | 12cm x 5.4cm x<br>3.3cm | 12 cm x 5.5cm x<br>2.5cm | unknown | dimensions do not<br>change device |
| 19. Housing<br>Materials and<br>Construction | plastic | plastic | plastic | performance.<br>Same materials. |

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| | Subject Device- Flex-MT + | | Predicate K083030<br>EMSI TENS-EMS-14(Flex MT) | | Comments | | | | |
|-------------------------------------------------|---------------------------|---------------------------------------------|------------------------------------------------|------------------------------|------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TENS mode | EMS mode | TENS mode | EMS mode | | | | | |
| Waveform | Asymmetrical<br>biphasic | Biphasic<br>symmetrical | Asymmetrical<br>biphasic | Biphasic<br>symmetrical | Asymmetrical<br>biphasic | Biphasic<br>symmetrical | Asymmetrical<br>biphasic | Biphasic<br>symmetrical | Same<br>waveforms |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Same<br>shape | | | | |
| Maximum<br>Output<br>Voltage | 43.2V @ 500Ω | 43.2V @ 500Ω | 41V@500 Ω | 28V@500 Ω | 41V @ 500 Ω | 29.5V<br>@ 500 Ω | The<br>maximum<br>output<br>voltage @<br>500Ω of<br>the subject<br>device is<br>within the<br>range of<br>the EMSI<br>and EMPI<br>predicates.<br>All within<br>acceptable<br>limits of<br>IEC<br>60601-1 | | |
| Maximum<br>Output<br>Current | | | | | 82mA @ 500Ω | 56mA @ 500Ω | 82 mA @500Ω | 59 mA<br>@500Ω | Subject<br>device has<br>increase<br>output<br>current<br>available<br>when<br>compared<br>to the<br>EMSI<br>predicate,<br>but within<br>range of<br>the EMPI<br>predicate.<br>All within<br>acceptable<br>limits of<br>IEC<br>60601-1 |
| | 86.4mA @ 500Ω | 86.4mA @<br>500Ω | 86.4mA @ 500Ω | 86.4mA @ 500Ω | | | | | |
| Pulse<br>Width per<br>phase | 50-400µsec | | 50-400µsec | | 50-300 µsec | | 50-300 µsec | | Subject<br>device has<br>increased<br>selection<br>of pulse<br>width<br>option<br>when<br>compared<br>to EMSI<br>predicate,<br>but same<br>option as<br>EMPI<br>predicate. |
| Max<br>Phase<br>Duration<br>(Positive<br>Phase) | $400\mu s$<br>=0.4ms | $400\mu s$<br>=0.4ms | $400\mu s$<br>=0.4ms | $400\mu s$<br>=0.4ms | N/A | 50-300 $\mu s$ | N/A | 50-300 $\mu s$ | |
| Max<br>Phase<br>Duration<br>(Negative<br>Phase) | 2.6ms | $400\mu s$<br>=0.4ms | 2.6ms | $400\mu s$<br>=0.4ms | - | - | | | |
| Pulse<br>Frequency<br>Max Duty<br>factor | 2-150 Hz<br>0.060 | 2-150 Hz<br>0.120 | 2-150 Hz<br>0.060 | 2-150 Hz<br>0.120 | 2-150Hz<br>0.045 | 2-150 Hz<br>0.090 | 2-150Hz<br>0.045 | 2-150 Hz<br>0.090 | Same<br>pulse<br>frequencies available |
| Subject Device- Flex-MT + | | | | | Predicate K083030<br>EMSI TENS-EMS-14(Flex MT) | | | | |
| Multi-<br>phasic<br>waveform<br>s | Yes | yes | Yes | yes | yes | yes | yes | yes | |
| Net<br>Charge<br>( $\mu$ C per<br>pulse) | 14.6 @ 500 $\Omega$ | 0<br>(symmetrical<br>phases result<br>in 0) | 14.6 @ 500 $\Omega$ | 0<br>(symmetrical<br>phases) | 24.5 @ 500 $\Omega$ | 0 (symmetrical<br>phases) | 24.6 $\mu$ C @<br>500 $\Omega$ | 0<br>(symmetrical phases) | All within<br>acceptable<br>limits of<br>IEC 60601-<br>1 |

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| Maximum<br>Current<br>Density,<br>(mA/cm²) | 1.83 @500Ω | 2.82 @500Ω | 1.83 @500Ω | 2.82 @500Ω | 0.26 @<br>500 Ω | 0.35 @ 500 Ω | 0.26 @ 500 Ω | 0.37 @ 500 Ω | All within<br>acceptable<br>limits of<br>IEC<br>60601-1 |
|--------------------------------------------------|---------------------------------------|-------------------------------------------|---------------------------------------|---------------------------------|-------------------|--------------------------|-------------------|-------------------|---------------------------------------------------------|
| Maximum<br>Power<br>Density,<br>(W/cm²) | 0.000858<br>@500Ω | 0.000858<br>@500Ω | 0.000858<br>@500Ω | 0.000858@500 Ω | 0.0105<br>@ 500 Ω | 0.0098 @ 500 Ω | 0.0105 @<br>500 Ω | 0.0109 @<br>500 Ω | |
| Maximum<br>Pulse<br>Duration | 400µs+2.6ms<br>=0.4ms+2.6ms<br>=3.0ms | 400µs+400µs<br>=800µs<br>=0.8ms | 400µs+2.6ms<br>=0.4ms+2.6ms<br>=3.0ms | 400µs+400µs<br>=800µs<br>=0.8ms | - | - | - | - | |
| Additional<br>Features<br>(if<br>applicable<br>) | | Patient compliance timer, battery charger | | | | Patient compliance timer | | | |

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| | Subject Device- Flex-MT + | | | | Predicate K021100<br>EMPI 300 PV (TENS and EMS<br>modes only) | Comments | |
|----------------------------------------------|-------------------------------------------|---------------------------------------------|-----------------------------------------------------|---------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | TENS mode | | EMS mode | | TENS and EMS mode | Same modes | |
| Waveform | Asymmetrical<br>biphasic | Biphasic<br>symmetrical | Asymmetrical<br>Biphasic<br>biphasic<br>symmetrical | | Asymmetrical biphasic, Biphasic<br>symmetrical | Same waveforms | |
| Shape | Rectangular | | Rectangular | | Rectangular | Same shape | |
| Maximum<br>Output<br>Voltage | 43.2V @ 500Ω | 43.2V @ 500Ω | 43.2V @ 500Ω | 43.2V @ 500Ω | 50V@500 Ώ | The maximum output voltage of the<br>subject device is within the range of<br>the EMSI and EMPI predicates. All<br>within acceptable limits of IEC<br>60601-1 | |
| Maximum<br>Output<br>Current | 86.4mA @ 500Ω | 86.4mA @<br>500Ω | 86.4mA @ 500Ω | 86.4mA @<br>500Ω | 100mA @, 500 Ώ | The maximum output current of the<br>subject device is within the range of<br>the EMSI and EMPI predicates. All<br>within acceptable limits of IEC<br>60601-1 | |
| Pulse<br>Width per<br>phase | 50-400 usec | | 50-400 usec | | 50-400 usec | Same range | |
| Max Phase<br>Duration<br>(Positive<br>Phase) | 400us<br>=0.4ms | 400us<br>=0.4ms | 400us<br>=0.4ms | 400us<br>=0.4ms | | | |
| Max Phase<br>Duration<br>(Negative<br>Phase) | 2.6ms | 400us<br>=0.4ms | 2.6ms | 400us<br>=0.4ms | | | |
| | | | | | | | |
| Phase<br>duration | 50-400 µsec | 50-400 µsec | 50-400 µsec | 50-400 µsec | Unknown | --- | |
| Net<br>Charge<br>(µC per<br>pulse) | 14.6 @500Ω | 0<br>(symmetrical<br>phases result<br>in 0) | 14.6 @500Ω | 0<br>(symmetrical<br>phases) | Unknown | --- | |
| Maximum<br>Phase<br>Charge,<br>( μ C) | 14.6uC<br>@ 500Ω | 0uC @ 500Ω | 14.6 uC @<br>500Ω | 0 uC @<br>500Ω | 40 uC @ 500 Ώ | All within acceptable limits of IEC<br>60601-1 | |
| Maximum<br>Current<br>Density,<br>(mA/cm²) | 14.6 @500Ω | 0@500Ω | 14.6 @500Ω | 0@500Ω | 0.84 @ 500 Ω<br>2"square electrode | All within acceptable limits of IEC<br>60601-1 | |
| Maximum<br>Power<br>Density,<br>(W/cm²) | 0.000858W/cm2<br>@500Ω | 0.000858<br>W/cm2<br>@ 500Ω | 0.000858<br>W/cm2<br>@500Ω | 0.000858<br>W/cm2<br>@500Ω | 0.0088W/cm2 @ 500 Ώ<br>2"square electrode | All within acceptable limits to avoid<br>thermal burn. | |
| Maximum<br>Pulse<br>Duration | 400µs+2.6ms<br>=0.4ms+2.6ms<br>=3.0ms | 400µs+400µs<br>=800µs<br>=0.8ms | 400µs+2.6ms<br>=0.4ms+2.6ms<br>=3.0ms | 400µs+400µs<br>=800µs<br>=0.8ms | --- | | |
| Additional<br>Features<br>(if<br>applicable) | Patient compliance timer, battery charger | | | | Battery charger | Same feature | |

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Clinical Data: No clinical study data is provided in support of this submission.

#### Substantial Equivalence

Based on the Flex-MT+ and the predicate device technical characteristics, performance, and indications for use, the substantially equivalent to the EMSI Flex MT and the EMPI 300V. As detailed in the tables above, the differences between the subject and predicate devices do not adversely impact the FlexMT+ safety and effectiveness for it's substantial equivalence to the predicates.