NEUROTECH PLUS

K112258 · Bio-Medical Research, Ltd. · GZJ · Jan 9, 2012 · Neurology

Device Facts

• Record ID: K112258
• Device Name: NEUROTECH PLUS
• Applicant: Bio-Medical Research, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jan 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dependent on the program chosen, the Neurotech Plus, Type 413 can deliver Neuromuscular Electrical Stimulation (NMES) for the activation of muscle for rehabilitation and/or Transcutaneous Electrical Nerve Stimulation (TENS) for the activation of nerves for neuromodulation and management of pain.

Device Story

Neurotech Plus is a portable, two-channel, battery-operated system providing NMES and TENS. Input consists of lead-wire assemblies containing an ID chip (EEPROM) that identifies pre-programmed stimulation parameters. The device transforms these inputs into electrical stimulation delivered via electrodes to the patient. Operated by clinicians or patients under prescription, the device features ten program sets (varying by model) for muscle activation or pain management. Healthcare providers use the device to facilitate rehabilitation or pain relief; output affects clinical decision-making by providing targeted electrical stimulation to nerves or muscles. Benefits include improved range of motion, muscle re-education, and pain reduction.

Clinical Evidence

Bench testing only. No clinical data submitted.

Technological Characteristics

Portable, two-channel, battery-operated stimulator. Waveforms: pulsed, symmetric, biphasic. Connectivity: lead-wire assembly with ID chip (EEPROM) for program identification. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, I.S. EN ISO 14971. No software algorithm class specified; parameters are pre-programmed.

Indications for Use

Indicated for patients requiring NMES for range of motion maintenance/increase, prevention/retardation of disuse atrophy, muscle re-education, muscle spasm relaxation, increased local blood circulation, and prevention of post-surgical venous thrombosis. Indicated for TENS for symptomatic relief of chronic intractable pain, arthritis pain, post-surgical/post-trauma pain, and osteoarthritis of the knee (specific models). Prescription use only.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• MediStim XP, Type 281 (K082011)
• MediTens XP, Type 458 (K082011)
• Staodyn® Max, Model 4470 (K061516)
• Bionicare Stimulator System Model Bio-1000 (K971437)

Submission Summary (Full Text)

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K112258

This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

## 1. Contact Details

| Name: | Anne-Marie Keenan |
|------------|-------------------------------------------------------------------------------|
| Address: | Bio-Medical Research Ltd.,<br>Parkmore Business Park, West<br>Galway, Ireland |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Prepared: | November ,2, 2011 |

# 2. Device Name and Regulation

| Trade Name of Device: | Neurotech Plus, Type 413 |
|-----------------------|------------------------------------------------------------|
| Regulation Number: | 21 CFR 882.5890 |
| Regulation Name | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ, NYN, IPF |
| Device Class: | II |

# 3. Identification of Equivalent Legally Marketed Device

| 510(k) Number: | K082011 |
|----------------|---------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | MediStim XP, Type 281 |

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| 510(k) Number: | K082011 |
|----------------|--------------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | MediTens XP, Type 458 |
| 510(k) Number: | K061516 |
| Manufacturer: | Compex Technologies |
| Trade Name: | Staodyn® Max, Model 4470 |
| 510(k) Number: | K971437 |
| Manufacturer: | Murray Electronics |
| Trade Name | Bionicare Stimulator System Model Bio-1000 |

## 4. Description of Device

The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.

The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.

The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.

## 5. Statement of Intended Use/Indications for Use

Intended Use: Dependent on the program chosen, the Neurotech Plus, Type 413 can deliver Neuromuscular Electrical Stimulation (NMES) for the activation of muscle for rehabilitation

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and/or Transcutaneous Electrical Nerve Stimulation (TENS) for the activation of nerves for neuromodulation and management of pain.

#### Indications for Use:

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Models 431, 432, 433, 434, 436, 439, & 440 offer a combination of NMES or TENS programs.

#### NMES Indications for Use

Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery

#### TENS Indications for Use

Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432, 433 only)

## Models 437, 441 (NMES only indications for use)

Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery

#### Model 438 (TENS only indications for use)

Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain

Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

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# 6. Summary of Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Neurotech Plus device. No new clinical tests have been submitted as part of this premarket notification.

The Neurotech Plus device complies with the following international standards:

- IEC 60601-1 (1998) + A1 (1991) + A2 (1995) Medical Electrical Equipment Part 1: . General Requirements for Safety.
- . IEC 60601-2-10 (1987) + A1 (2001) Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.
- IEC 60601-1-2:2001 Medical electrical equipment Part 1-2: General requirements . for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests :
- I.S. EN ISO 14971 2007 .

## 6.1 Program Sets

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Tables 6.1.1 to 6.1.10 show the program parameters for each model of the Neurotech Plus.

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| Table 6.1+.1<br>Model 431 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Pulse Width<br>(usec) | Cont<br>(sec.) | Relax<br>(sec.) | Ramp<br>Up<br>(sec.) | Ramp<br>Down<br>(sec.) | Additional Functions | Treatment<br>Time<br>(minutes) |
|---------------------------|----------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------|----------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1 | P1 | Adj | 125 to 4;<br>modulates<br>(decreases) between<br>125 to 4 in 12<br>second cycle -<br>remains at 125 for 3<br>seconds and 4 for 3<br>seconds of cycle<br>time<br>(see Note 1) | 150 to 250;<br>modulates<br>(increases) between<br>150 to 250 in 12<br>second cycle -<br>remains at 150 for 3<br>seconds and 250 for<br>3 seconds of cycle<br>time<br>(see Note 1) | | | | | | Open |
| 2 | P2 | Adj | 99 | 200 | | | | | Burst Toggle - 4 Hz, 250 usec Activation and<br>output remains constant after pressing the burst<br>button. Press Burst again to cancel. No ramp<br>up/down will be implemented | Open |
| 3 | P3 | Adj | Ch 1: 4<br>Ch 2: 125 | 200 | | | | | Criss-cross Function, Burst - Ch1 125 Hz, 200 usec<br>& Ch2 125 Hz, 200 usec. Activation and output<br>remains constant for 10 minutes after burst button<br>pressed. No ramp up/down will be implemented<br>(See note 2) | Open |
| 4 | P4 | Adj | 4 | 250 | | | | | Burst - 125 Hz, 175 usec. Activation and output<br>remains constant while pressing burst button. No<br>ramp up/down will be implemented | Open |
| 5 | P5 | Adj | 50 | 300 | 5 | | 15 | 1.0 | | 30 |
| 6 | P6 | Adj | 50 | 300 | 5 | | 10 | 1.0 | Trigger | 30 |
| 7 | P7 | Adj | 50 | 300 | 5 | | 5 | 1.0 | Trigger | 30 |
| 8 | P8 | Adj | 35 | 300 | 5 | | 10 | 1.0 | Trigger | 30 |
| 9 | P9 | Adj | 8 | 300 | 5 | | 5 | 1.0 | Trigger | 20 |
| 10 | P10 | Adj | 100<br>70 | 100<br>200 | 5 | | 15 | 1.0 | | 90<br>10 |
| | | Adj | 100<br>70 | 100<br>200 | 5 | | 15 | 1.0 | | 90<br>20 |
| | | Adj | 100 | 100 | | | | | | 90 |
| Table 6.1.2<br>Model 432 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Pulse Width<br>(usec) | Contract<br>(sec.) | Relaxation<br>(sec.) | Ramp Up<br>(Sec.) | Ramp<br>Down<br>(Sec.) | Additional Functions | Treatment Time<br>(minutes) |
| 1 | P1 | Adj | 125 to 4;<br>modulates (decreases)<br>between 125 to 4 in 12<br>second cycle - remains at<br>125 for 3 seconds and 4<br>for 3 seconds of cycle<br>time | 150 to 250;<br>modulates (increases)<br>between 150 to 250 in<br>12 second cycle -<br>remains at 150 for 3<br>seconds and 250 for 3<br>seconds of cycle time | | | | | Burst-4Hz, 250 usec.<br>Activation and output<br>remains constant<br>while pressing burst<br>button. No ramp<br>up/down will be<br>implemented | Open |
| 2 | P2 | Adj | 99 | 200 | | | | | | Open |
| 3 | P3 | Adj | Ch 1: 4<br>Ch 2: 125 | 200 | | | | | Criss-cross Function,<br>Burst - Ch1 125 Hz,<br>200 usec & Ch2 125<br>Hz, 200 usec.<br>Activation and output<br>remains constant for<br>10 minutes after burst<br>button pressed. No<br>ramp up/down will be<br>implemented.<br>(See note 2) | Open |
| 4 | P4 | Adj | 4 | 250 | | | | | Burst-125Hz, 175<br>usec. Activation and<br>output remains<br>constant while<br>pressing burst button.<br>No ramp up/down will<br>be implemented | Open |
| 5 | P5 | Adj | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| 6 | P6 | Adj | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 7 | P7 | Adj | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adj | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 20 |
| 9 | P9 | Adj | 8 | 300 | 5 | 5 | 1.0 | .5 | Trigger | 20 |
| 10 | P10 | Adj | 70<br>100 | 100<br>200 | 5 | 15 | 1.0 | 0.5 | | 70 |
| | | | 70<br>100 | 100<br>200 | 5 | 15 | 1.0 | 0.5 | | 70 |

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| Table 6.1.3<br>Model 433 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Contraction<br>(sec.) | Relaxation<br>(sec.) | Ramp Up<br>(Sec.) | Ramp<br>Down<br>(Sec.) | Additional<br>Functions | Treatment<br>Time<br>(minutes) |
|--------------------------|----------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------|----------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 125 to 4;<br>modulates<br>(decreases)<br>between 125 to<br>4 in 12 second<br>cycle - remains<br>at 125 for 3<br>seconds and 4<br>for 3 seconds of<br>cycle time | 150 to 250;<br>modulates<br>(increases)<br>between 150 to<br>250 in 12<br>second cycle -<br>remains at 150<br>for 3 seconds<br>and 250 for 3<br>seconds of<br>cycle time | | | | | | Open |
| 2 | P2 | Adjustable | 125 | 175 | | | | | | Open |
| 3 | P3 | Adjustable | 4 | 250 | | | | | Burst -<br>Frequency of 4<br>Hz, pulse width<br>of 250 usec.<br>Activation and<br>output remains<br>constant while<br>pressing burst<br>button. Will<br>ramp down over 3<br>sec. and up over 3<br>sec | Open |
| 4 | P4 | Adjustable | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| 5 | P5 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| 7 | P7 | Adjustable | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 8 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| 9 | P9 | Adjustable | 100 | 100 | | 15 | 1.0 | 0.5 | Burst -<br>Frequency of 125<br>Hz. pulse width<br>of 175 usec.<br>Activation and<br>output remains<br>constant while<br>pressing burst<br>button. No ramp<br>upodwn will be<br>implemented. | 70 |
| 10 | P10 | Adjustable | 70 | 200 | 5 | 15 | 1.0 | 0.5 | Trigger | 20 |
| Table 6.1.4<br>Model 434 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Contraction<br>(sec.) | Relaxation<br>(sec.) | Ramp<br>Up<br>(Sec.) | Ramp<br>Down<br>(Sec.) | Additional<br>Functions | Treatment<br>Time<br>(minutes) |
| 1 | P1 | Adjustable | 80 | 120 | Continuous<br>Stimulation | | 2 | | | Open |
| 2 | P2 | Adjustable | 2 | 180 | Continuous<br>Stimulation | | 2 | | | Open |
| 3 | P3 | Adjustable | 80 | 70-120 | Continuous<br>Stimulation | | 2 | | | Open |
| 4 | P4 | Adjustable | 80/2 | 180 | Continuous<br>Stimulation | | 2 | | | Open |
| 5 | P5 | Adjustable | 9/2 | 300 | Continuous<br>Stimulation | | 2 | | | 20 |
| 6 | P6 | Adjustable | 8 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 20 |
| 7 | P7 | Adjustable | 35 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 50 | 300 | 5 | 15 | 1.0 | 0.5 | Trigger | 30 |
| 9 | P9 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 10 | P10 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| Table 6.1.5<br>Model 436 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Contraction<br>(sec.) | Relaxation<br>(sec.) | Ramp Up<br>(Sec.) | Ramp Down<br>(Sec.) | Additional Functions | Treatment<br>Time<br>(minutes) |
| 1 | P1 | Adjustable | 125 to 4:<br>modulates<br>(decreases)<br>between 125 to 4<br>in 12 second<br>cycle - remains at<br>125 for 3 seconds<br>and 4 for 3<br>seconds of cycle<br>time | 150 to 250;<br>modulates<br>(increases)<br>between 150 to<br>250 in 12 second<br>cycle - remains at<br>150 for 3 seconds<br>and 250 for 3<br>seconds of cycle<br>time | NA | NA | NA | NA | None | Open |
| 2 | P2 | Adjustable | 125 to 4;<br>modulates<br>(decreases)<br>between 125 to 4<br>in 12 second<br>cycle - remains at<br>125 for 3 seconds<br>and 4 for 3<br>seconds of cycle<br>time | 50 to 100;<br>modulates<br>(increases)<br>between 50 to 100<br>in 12 second cycle<br>- remains at 50 for<br>3 seconds and 100<br>for 3 seconds of<br>cycle time | NA | NA | NA | NA | None | Open |
| 3 | P3 | Adjustable | 125 | 150 | NA | NA | NA | NA | Burst - Frequency is<br>80hz, pulse width 300<br>usec with 8 pulses per<br>burst;<br>2 bursts per second. 12<br>second cycle time - 2<br>seconds modulation<br>from normal to burst, 8<br>seconds at burst, 2<br>seconds modulating<br>from burst to normal.<br>Frequency will<br>increment/decrement<br>during the transition<br>to/from burst. | Open |
| 4 | P4 | Adjustable | 80 | 300 | 10 | 25<br>(Remove<br>Beep) | 1.5 | 1.5 | Trigger | 30 |
| 5 | P5 | Adjustable | 50 | 300 | 10 | 20 (Remove<br>Beep) | 1.5 | 1.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 35 | 300 | 5 | 5 | 1.5 | 1.5 | Trigger | 30 |

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| Relax time | 5 seconds | 5 seconds | 5 seconds | seconds |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ramp Down Time | 2 seconds | 2 seconds | 2 seconds | 2 seconds |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Contract Time | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>seconds | 3 seconds | ANNUAL ALL PROPERTY LA CONSULT LE LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LE<br>seconds | seconds<br>----------------------------------- |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-A-<br>Ramp-Up time | 2seconds | 2seconds<br>- | And And Commend Commend Comments of Children<br>2seconds | 2seconds |
| A . A . A<br>Pulse Width | 2000 Js | Carles Market<br>225 Us | 2500s | 2700s |
| Carreland Contract<br>Frequency | 0Hz | 55Hz<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 55Hz<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A<br>50Hz<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Duration<br>STERE COLORIO CONSULTION | 20 minutes<br>A Land State State of States of Active Andrew<br>i | 25 minutes | 30 minutes | 40 minutes |
| Table 6.1.6<br>Model 437 | Program<br>Particle Property of Children Comments of Children | Program2<br>11-2017 Com | Program 3<br>Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children States of th | Program |

| Table 6.1.7<br>Model 438 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Pulse | Treatment Time<br>(minutes) |
|--------------------------|----------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------|
| 1 | P1 | Adjustable | 125 to 4;<br>modulates (decreases) between 125 to 4 in 12 second cycle – remains at 125 for 3 seconds and 4 for 3 seconds of cycle time | 150 to 250;<br>modulates (increases) between<br>150 to 250 in 12 second cycle -<br>remains at 150 for 3 seconds and<br>250 for 3 seconds of cycle time | NA | 45 |
| 2 | P2 | Adjustable | 125 to 4;<br>modulates (decreases) between 125 to 4 in 12 second cycle – remains at 125 for 3 seconds and 4 for 3 seconds of cycle time | 50 to 100;<br>modulates (increases) between 50<br>to 100 in 12 second cycle -<br>remains at 50 for 3 seconds and<br>100 for 3 seconds of cycle time | NA | 45 |
| 3 | P3 | Adjustable | 125 | 175 | NA | 45 |
| 4 | P4 | Adjustable | 4 | 250 | NA | 45 |
| 5 | P5 | Adjustable | Channel 1 - 4<br>Channel 2 - 125 | 175 | NA | 45 |
| 6 | P6 | Adjustable | 80 | 175 | 8 pulses per burst;<br>2 bursts per second | 45 |
| 7 | P7 | Adjustable | 125 to 50;<br>modulates (decreases) between 125 and 50 in 8 second cycle (4/4) | 175 | NA | 45 |
| 8 | P8 | Adjustable | 125 | 250 to 150;<br>modulates (decreases) between<br>250 and 150 in 8 second cycle<br>(4/4) | NA | 45 |
| 9 | P9 | Adjustable | 125 to 50;<br>modulates (decreases) between 125 to 50 in 6 second cycle (3/3) | 50 to 100;<br>modulates (increases) between 50<br>to 100 in 6 second cycle (3/3) | NA | 45 |
| 10 | P10 | Adjustable | 125 to 50;<br>modulates (decreases) hetween 125 and 50 in 10 second cycle (5/5) | 150 to 250;<br>modulates (increases) between<br>150 and 250 in 10 second cycle<br>(5/5) | NA | 45 |

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| Table 6.1.8<br>Model 439 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Contraction<br>(sec.) | Relaxation<br>(sec.) | Ramp Up<br>(Sec.) | Ramp Down<br>(Sec.) | Additional<br>Functions | Treatment<br>Time<br>(minutes) |
|--------------------------|----------------|------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------|-------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 50 | 300 | 5 | 5 | 1.0 | 0.5 | Trigger | 30 |
| 2 | P2 | Adjustable | 50 | 300 | 10 | 10 | 1.0 | 1.0 | Trigger | 30 |
| 3 | P3 | Adjustable | 50 | 300 | 10 | 20 | 1.5 | 1.0 | Trigger | 30 |
| 4 | P4 | Adjustable | 50 | 300 | 10 | 30 | 1.5 | 1.0 | Trigger | 30 |
| 5 | P5 | Adjustable | 35 | 250 | 8 | 25 | 1.5 | 1.0 | Trigger | 30 |
| 6 | P6 | Adjustable | 35 | 300 | 5 | 5 | 1.0 | 1.0 | Trigger | 30 |
| 7 | P7 | Adjustable | 10 | 250 | 10 | 10 | 1.5 | 1.0 | Trigger | 30 |
| 8 | P8 | Adjustable | 4 | 250 | | | | | Burst-125 Hz, 175 usec.<br>Activation and output remains constant while pressing burst button.<br>Will ramp up over 3 sec. and down over 3 sec | 45 |
| 9 | P9 | Adjustable | 125 | 175 | | | | | No-trigger | 45 |
| 10 | P10 | Adjustable | 125 to 4; modulates (decreases) between 125 to 4 in 12 second cycle - remains at 125 for 3 sec. and 4 for 3 sec. of cycle time | 150 to 250; modulates (increases) between 150 to 250 in 12 sec. cycle - remains at 150 for 3 sec. and 250 for 3 sec. of cycle time | | | | | No-trigger | 45 |

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| Table 6.1.9<br>Model 440 | Screen<br>Text | Intensity | Rate<br>(Hz or pps) | Width<br>(usec) | Contraction<br>(sec.) | Relaxation<br>(sec.) | Ramp Up<br>(Sec.) | Ramp<br>Down<br>(Sec.) | Additional Functions | Treatment<br>Time<br>(minutes) |
|--------------------------|----------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------|----------------------|------------------------|--------------------------------------|--------------------------------|
| 1 | P1 | Adjustable | 125 to 4;<br>modulates<br>(decreases)<br>between 125 to 4<br>in 12 second cycle<br>- remains at 125<br>for 3 seconds and<br>4 for 3 seconds of<br>cycle time | 150 to 250;<br>modulates<br>(increases)<br>between 150 to<br>250 in 12 second<br>cycle - remains at<br>150 for 3 seconds<br>and 250 for 3<br>seconds of cycle<br>time | | | | | | Open |
| 2 | P2 | Adjustable | 99 to 50;<br>modulates<br>(decreases)<br>between 99 and 50<br>in 8 second cycle<br>(4/4) | 150 to 250;<br>modulates<br>(increases)<br>between 150 to<br>250 in 8 second<br>cycle (4/4) | | | | | | Open |
| 3 | P3 | Adjustable | 125 | 175 | | | | | Criss-cross Function<br>(See note 3) | Open |
| 4 | P4 | Adjustable | 4 | 250 | | | 1.0 | | | |
| 5 | P5 | Adjustable | 50 | 300 | 5 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 6 | P6 | Adjustable | 50 | 300 | 10 | 10 | 1.0 | 0.5 | Trigger | 30 |
| 7 | P7 | Adjustable | 50 | 300 | 10 | 20 | 1.0 | 0.5 | Trigger | 30 |
| 8 | P8 | Adjustable | 50 | 300 | 10 | 30 | 1.0 | 0.5 | Trigger | 30 |
| 9 | P8 | Adjustable | 3…