REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S

K050046 · Compex Technologies, Inc. · IPF · Apr 13, 2005 · Physical Medicine

Device Facts

• Record ID: K050046
• Device Name: REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
• Applicant: Compex Technologies, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Interferential stimulation can be used for the following applications: - Relieve acute pain . - . Relieve and manage chronic pain - Relax muscle spasms . - Maintain and increase the range of motion . - Increase local blood circulation . Neuromuscular stimulation can be used for the following applications: - Relax muscle spasms . - Prevent or retard disuse atrophy . - Increase local blood circulation . - Re-educate muscles . - Maintain or increase the range of motion . - Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles Pulsed direct current stimulation can be used for the following applications: - Reduction of edema (under negative electrode) t - Reduction of muscle spasm . - Influencing local blood circulation (under negative electrode) . - Retardation or prevention of disuse atrophy . - Facilitation of voluntary motor function . - Maintenance or increase of range of motion . Interferential and Neuromuscular combination stimulation can be used for the following applications: - Reduction of edema (under negative electrode) . - Reduction of muscle spasm .

Device Story

IF 3Wave (Model 7110S) is a microprocessor-controlled, dual-channel, non-invasive electro-stimulator. It delivers four modalities: Interferential (IF), Neuromuscular Electrical Stimulation (NMES), Pulsed Direct Current (PDC), and combined IF/NMES. Device stores settings and compliance data for 90 days; data is downloaded via a battery charger/modem base for physician review. Physicians use reports to adjust treatment regimens. Device features include automatic overload/no-load trips, automatic shut-off, and patient override controls. Powered by a lithium-ion polymer rechargeable battery. Used in clinical or home settings under physician prescription to manage pain, muscle function, and circulation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, comparison of technical specifications, and functional equivalence to predicate devices.

Technological Characteristics

Microprocessor-controlled dual-channel stimulator. Case: ABS/PC blend. Power: Lithium-ion polymer rechargeable battery. Waveforms: Symmetrical biphasic square wave (0 net DC) and PDC. Output: 0-50 mA (IF) or 0-100 mA (NMES/PDC) into 500-1000 ohm loads. Features: Automatic overload/no-load trip, automatic shut-off, patient override. Connectivity: Modem-based data download for compliance reporting. Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for patients requiring pain relief (acute/chronic), muscle spasm relaxation, range of motion maintenance/increase, local blood circulation improvement, disuse atrophy prevention/retardation, muscle re-education, venous thrombosis prevention (postsurgical calf stimulation), edema reduction, and voluntary motor function facilitation.

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

• Staodyne, Inc. EMS+2 Neuromuscular Stimulation System (K926510)
• Medical Devices, Inc. Model IF-II Interferential Stimulation System (K923914)
• Staodyne, Inc. Model SporTX Pulsed Direct Current and TENS Stimulator (K921668)
• Axelgaard Manufacturing Company TENS Pals Plus Electrodes (K872976)
• Axelgaard Manufacturing Company Valutrode Electrodes (K970426)

Submission Summary (Full Text)

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KC50046

#### APR 1 3 2005

**Summary of Safety and Effectiveness:**

## Summary of Safety and Effectiveness

#### Applicant Information

Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112 Phone: [phone] [phone] FAX:

#### Contact Person

Brian J. Edwards, M.S. Director of Regulatory Affairs & Quality Assurance

## Date Summary Prepared

September 1, 2004

## Device identification

| Trade / Proprietary Name: | IF 3Wave Interferential Muscle Stimulator System,<br>Model 7110S |
|---------------------------|------------------------------------------------------------------|
| Common / Usual Name: | Muscle and Interferential Current |
| Classification Name: | 21 CFR 890.5850 "Powered Muscle Stimulator" |
| Product Classification: | Class II |
| Product Code: | IPF |

{1}------------------------------------------------

### Legally Market Predicate Devices

| Predicate Device | 510(k) Number / Clearance Date |
|--------------------------------------------------------------------------|--------------------------------|
| Staodyne, Inc. EMS+2 Neuromuscular<br>Stimulation System | K926510 / August 11, 1993 |
| Medical Devices, Inc. Model IF-II<br>Interferential Stimulation System | K923914 / November 6, 1992 |
| Staodyne, Inc. Model SporTX Pulsed<br>Direct Current and TENS Stimulator | K921668 / August 3, 1992 |
| Axelgaard Manufacturing Company<br>TENS Pals Plus Electrodes | K872976 / September 22, 1987 |
| Axelgaard Manufacturing Company<br>Valutrode Electrodes | K970426 / May 9, 1997 |

The IF 3Wave Interferential Stimulator System, Model 7110S is comparable in type and function and are substantially equivalent to the following predicate devices.

#### Device Description

The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).

The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.

Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.

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# Technical Characteristics

The IF functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare IF-II device.

| Interferential Modality. | | |
|--------------------------------------------------|----------------------------------------------------------|----------------------------------------------|
| | IF-II<br>Model 7100S | IF 3Wave<br>Model 7110S |
| 510(k) Number | K923914 | |
| Manufacturer | Medical Devices, Inc. | Compex Technologies, Inc. |
| Power Source | 4 AA rechargeable batteries<br>Line Powered Repack | Lithium ion polymer rechargeable<br>battery. |
| Weight | 12 oz, with battery | 12 oz, with battery |
| Dimensions | 3.2 x 5.2 x 1.15 in. | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Patient Leakage Current* | | |
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of Output<br>Channels | 2 | Same |
| Method of Channel<br>Isolation | Transformer isolation | Same |
| Regulated Current or<br>Voltage | Voltage | Same |
| Software, Firmware,<br>Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Yes, 5 kohms |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator Display<br>On/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Waveform | Symmetrical biphasic square<br>wave with 0 net DC | Same |
| Pulse Width | 125 microseconds | Same |
| Carrier Pulse Frequency<br>(Channel 1) | 4000 Hz, fixed | Same |
| Adjustable Pulse<br>Frequency<br>(Channel 2) | 4001 — 4150 Hz | Same |
| Interferential Beat<br>Frequency | 1 - 150 Hz | Same |
| Pulse Amplitude | 0 - 50 mA, adjustable in 1 mA<br>steps into 500 ohm load | Same |

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| Indications for Use | Relieve acute pain<br>Relieve and manage chronic<br>pain<br>Relax muscle spasms<br>Maintain and increase the range<br>of motion<br>Increase local blood circulation | Same |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Number of Continuous<br>Treatments | 1 | Same |
| Continuous Treatment<br>Time Selection | 20 minutes, fixed | 10 - 60 minutes, selectable in 5<br>minute steps |
| Number of Variable Sweep<br>Programs | 3 | 4 |
| Sweep Treatment Time<br>Selection | 20 minutes, fixed | 10 - 60 minutes, selectable in 5<br>minute steps |
| Sweep Program Cycle<br>Times | 1 sec Up / 1 sec Down<br>6 sec Up / 6 sec Down | 6 sec Up / 6 sec Down<br>12 sec Up / 12 sec Down<br>24 sec Up / 24 sec Down |
| Number of Fixed<br>Parameter Sweep<br>Programs | 0 | 7 |
| Sweep Program Frequency<br>Range | 1 - 150 Hz, selectable<br>continuously using a rheostat | 1 - 150 Hz, selectable in 1 Hz steps |
| Maximum Charge per<br>Pulse | 120 microcoulombs | Same |
| Maximum Output Voltage | 50 volts, peak-to-peak, 500 ohm<br>load | Same |
| Peak Output Current | 100 mA, peak-to-peak, 500<br>ohm load | Same |
| Net Charge per Pulse | 0 microcoulombs, biphasic<br>waveform | Same |
| Max Phase Charge | 6.25 microcoulombs | Same |
| Max Current Density# | 1.937 mA / cm2 (average) | Same |
| Max Power Density# | 0.097 W/cm2 (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with Voluntary<br>Standards | Unknown | Yes, refer to page 43 of the<br>submission for list |
| NMES Modality. | | |
| EMS+2<br>Model 6840S | IF 3Wave<br>Model 7110S | |
| 510(k) Number | K926510 | |
| Manufacturer | Staodyne, Inc. | Compex Technologies, Inc. |
| Power Source | 9 volt battery - alkaline or nickel<br>metal hydride rechargeable | Lithium ion polymer<br>rechargeable battery. |
| Weight | 7.97 oz, with battery | 12 oz, with battery |
| Dimensions | 5.4 x 3.2 x 1.2 in. | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Waveform | Symmetrical biphasic with zero<br>net DC component | Same |
| Patient Leakage Current* | | |
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of Output Channels | 2 | Same |
| Method of Channel Isolation | N/A | Same |
| Regulated Current or Voltage | Current | Same |
| Software, Firmware,<br>Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Same |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator Display | | |
| On/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Number of Preset Programs | 0 | 6 |
| Pulse Width | 50 - 300 microseconds, adjustable | 70 - 300 microseconds in 10<br>microsecond steps |
| Pulse Frequency | 4 - 80 Hz, adjustable | 10 – 80 Hz in 5 Hz steps |
| Pulse Amplitude | 0 – 100 mA across a 1000 Ohm<br>load, adjustable | 0 - 100 mA in 1 mA steps<br>across a 1000 Ohm load |
| Indications for Use | Relax muscle spasms<br>Prevent or retard disuse atrophy<br>Increase local blood circulation<br>Re-educate muscles<br>Maintain or increase the range of<br>motion | Same |
| | | |
| | Prevent venous thrombosis using<br>immediate postsurgical stimulation<br>on calf muscles | |
| Treatment Time Selection | 15, 30, or 60 minutes, or<br>Continuous, selectable | 10 - 60 minutes, in 5 minute<br>increments |
| Cycle ON Time | 0.5 - 30 seconds, adjustable | 1 - 30 seconds, in 1 second<br>increments |
| Cycle OFF Time | 0.1 - 60 seconds, adjustable | 1 - 60 seconds, in 1 second<br>increments |
| Ramp-Up Time | 0.1 - 6, adjustable | 0 -10 seconds, in 1 second<br>increments |
| Ramp-Down Time | 0.1 - 6 seconds, adjustable | 0 - 10 seconds, in 0.5 second<br>increments |
| Maximum Output Voltage | 100 volts, 0-to-peak, 1000 ohm<br>load | Same |
| Peak Output Current | 100 mA, 0 -to-peak, 1000 ohm<br>load | Same |
| Maximum Charge per Pulse | 30 microcoulombs | Same |
| Net Charge per Pulse | 0 microcoulombs, biphasic<br>waveform | Same |
| Max Phase Charge | 30 microcoulombs | Same |
| Max Current Density# | 0.19 mA/cm2 (average) | Same |
| Max Power Density# | 0.019 W/cm2 (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with Voluntary<br>Standards | Unknown | Yes, refer to page 43 of the<br>submission for list |
| PDC Modality. | | |
| | SporTX<br>Model 7700S | IF 3Wave<br>Model 7110S |
| 510(k) Number | K921668 | |
| Manufacturer | Staodyne, Inc. | Compex Technologies, Inc. |
| Power Source | 9 volt alkaline or rechargeable<br>battery | Lithium ion polymer<br>rechargeable battery. |
| Weight | 4.4 oz, with battery | 12 oz, with battery |
| Dimensions | 2.1 x 4.2 x 0.9 in | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Patient Leakage Current* | | |
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of Output Channels | 2 | Same |
| Method of Channel Isolation | N/A | Same |
| Regulated Current or<br>Voltage | Current | Same |
| Software, Firmware,<br>Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Same |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator Display | | |
| On/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Waveform 1 | Symmetrical biphasic squarewave<br>with zero net DC | Same |
| Waveform 2 | Unbalanced Triphasic with<br>positive net DC | Same |
| Number of Preset Programs | 0 | 3 |
| Pulse Width | Biphasic: 60 microseconds<br>Triphasic: 60 microseconds | Same |
| Pulse Frequency | Biphasic: 278 Hz<br>Triphasic: 222 Hz | Same |
| Pulse Amplitude | 0 - 100 mA across a 1000 Ohm<br>Load, adjustable | 0 - 100 mA in 1 mA<br>increments across a 1000<br>Ohm load |
| Indications for Use | Reduction of edema (under<br>negative electrode) | Same |
| | | |
| | Reduction of muscle spasm | |
| | Influencing local blood circulation | |
| | Retardation or prevention of<br>disuse atrophy | |
| | Facilitation of voluntary motor<br>function | |
| | Maintenance or increase of range<br>of motion | |
| Treatment Time Selection | 38 minutes or Continuous,<br>selectable | 30 - 60 minutes, in 5 minute<br>increments |
| Maximum Output Voltage | 100 Volts, 100 ohm load | Same |
| Maximum Charge per Pulse | 6 microcoulombs | Same |
| Average DC Current | 266 microamperes | 300 microamperes |
| Net Charge per Pulse | 0 microcoulombs, biphasic<br>waveform | Same |
| Max Phase Charge | 60 microcoulombs per pulse | Same |
| Max Current Density# | 0.13 mA/cm² (average) | Same |
| Max Power Density# | 0.013 W/cm² (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with Voluntary<br>Standards | Unknown | Yes, refer to page 43 of the<br>submission for list |

*Patient Leakage Current was determined following test procedure within IEC 601-1

#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.

{4}------------------------------------------------

The NMES functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare EMS+2 device.

{5}------------------------------------------------

*Patient Leakage Current was determined following test procedure within IEC 601-1

#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.

{6}------------------------------------------------

The PDC functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare SporTX device.

{7}------------------------------------------------

## *Patient Leakage Current was determined following test procedure within IEC 601-1

#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.

{8}------------------------------------------------

### Indications for use

The IF 3Wave Interferential Stimulator System is intended for:

Interferential stimulation can be used for the following applications:

- Relieve acute pain .
- . Relieve and manage chronic pain
- Relax muscle spasms .
- Maintain and increase the range of motion .
- Increase local blood circulation .

Neuromuscular stimulation can be used for the following applications:

- Relax muscle spasms .
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles

Pulsed direct current stimulation can be used for the following applications:

- Reduction of edema (under negative electrode) t
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .

Interferential and Neuromuscular combination stimulation can be used for the following applications:

- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .

{9}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Compex Technologies, Inc. c/o Mr. Daniel Lehtonen Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K050046

Trade/Device Name: IF 3 Wave Interferential Muscle Stimulator System, Model 7110S Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Name: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief and Interferential current therapy Regulatory Class: II Product Codes: GZJ, IPF and LIH Dated: March 28, 2005 Received: March 29, 2005

Dear Mr. Lehtonen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 r reaso or admised 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{10}------------------------------------------------

Page 2 - Mr. Daniel Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin mailing of substantial equivalence of your device to a legally premailed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at no 101-11-1120. Also, please note the regulation entitled, Colliact the Office of Compilance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Renele K

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 050046 510(k) Number (if knowm):

#### Device Name

Compex Technologies IF 3Wave Interferential Stimulator System, Model 7110S.

#### Indications for Use

Interferential stimulation can be used for the following applications:

- Relieve acute pain .
- Relieve and manage chronic pain .
- Relax muscle spasms ●
- Maintain and increase the range of motion .
- Increase local blood circulation .

Neuromuscular stimulation can be used for the following applications:

- . Relax muscle spasms
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles

Pulsed direct current stimulation can be used for the following applications:

- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restorative

Ko50046