CONTOUR TECHNOLOGY MUSCLE STIMULATOR

K111476 · Contour Technology · NGX · May 23, 2012 · Physical Medicine

Device Facts

• Record ID: K111476
• Device Name: CONTOUR TECHNOLOGY MUSCLE STIMULATOR
• Applicant: Contour Technology
• Product Code: NGX · Physical Medicine
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training. The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles. The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.

Device Story

Powered muscle stimulator delivers electrical stimulation to healthy skeletal muscles to improve performance, tone, and strength. Device uses 4 AAA batteries to generate monophasic, rectangular, voltage-regulated output signals. Signals transmitted via two channels to gel pad electrodes placed on target muscle regions (upper/lower back, biceps, triceps, forearms, deltoids, abdomen, gluteus, hamstrings, quadriceps, calves). Motor neuron stimulation triggers muscle fiber contraction. Operated by user in home setting; optional hands-free accessories (Ab Belt, BackPad) available. Device features pre-set programs with optimized pulse rate, duration, and rest times. User interface allows individual channel regulation. Benefits include muscle training and development of firmer muscles.

Clinical Evidence

No clinical data. Device does not diagnose, cure, mitigate, treat, or prevent disease. Substantial equivalence supported by non-clinical bench testing, including system/software verification, environmental, safety, ESD/EMI, stress, shipping, and simulated use (usability) testing.

Technological Characteristics

Powered muscle stimulator; 4 AAA battery source. Monophasic, rectangular, voltage-regulated output. 2-channel delivery. Pulse duration 340 μs; frequency 1-120 Hz. Max current density 0.55 mA (rms)/cm². Plastic housing. Reusable gel pad electrodes. Independent channel regulation. Software-controlled pre-set programs.

Indications for Use

Indicated for healthy individuals seeking to improve or facilitate muscle performance, strengthen, or tone muscles. Specific accessories indicated for abdominal muscle strengthening/toning (Ab Belt) and lower back muscle stimulation (BackPad). Contraindicated for individuals with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Compex Sport (K011880)
• P4-Fitness (K031611)
• Slendertone Flex 515 (K030708)

Submission Summary (Full Text)

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# 5. 510(K) SUMMARY

### 5.1 Administrative Information

MAY 2 3 2012

### 5.1.1 Name and address

510(k) Owner/Sponsor:

Mike Esson Contour Technology 10 South 5th Street, Suite 990 Minneapolis, Minnesota 54402 Phone: [phone] Fax: [phone]

### Primary Contact Person

Sara Petrie Regulatory Consultant at Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: 5/15/2012

### 5.1.2 Device Name

| Trade Name | Contour Technology Muscle Stimulator |
|---------------------|--------------------------------------------------------------------------|
| Common Name | Muscle Stimulator |
| Classification Name | Powered Muscle Stimulator with Limited Output for Muscle<br>Conditioning |
| Classification | 21 CFR 890.5850<br>Class II |
| Product Code | NGX |
| Model | MX9 |

### 5.1.3 Applicant's Name

Contour Technology 10 South 5th Street, Suite 1000 Minneapolis, Minnesota 54402 Telephone: [phone] Fax: [phone]

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## 5.1.4 Substantial Equivalence

Contour Technology Muscle Stimulator covered by this substantially equivalent to other legally marketed devices namely the following:

- K011880, Compex Sport, Compex S.A. �
- . K031611, P4-Fitness, ValMed Corporation
- � K030708, Slendertone Flex 515, Bio-Medical Research Ltd.

The Contour Technology Muscle Stimulator and the predicate devices have the same intended use and similar indications, technological characteristics and principles of operation that includes the delivery of small amount of electrical stimulation to skeletal muscles for conditioning of the muscles. There are design and engineering differences between the Contour Technology Muscle Stimulator and the predicate devices. However, these differences do not raise new questions of safety or efficacy. Specifically, the only technological difference between the Contour Technology Muscle Stimulator and its predicates is the shape of the stimulator, user interface and specific duration and pulse energy of each of the pre-set programs. These differences do not present any new issues of safety or effectiveness as the Contour Technology Muscle Stimulator is substantially similar to the three cited predicates. Further, performance testing conducted by the company demonstrates that the device meets the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning.

Thus, the Contour Technology Muscle Stimulator is substantially equivalent to the predicate devices.

## 5.1.5 Device Description

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles.

The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries.

Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.

## 5.1.6 Indications for Use/Intended Use

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.

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The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.

The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.

## 5.1.7 Contraindications

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

## 5.1.8 Summary of Technological Characteristics compared to predicate devices

Technological characteristics compared to predicate devices can be found in Table 1.

| ltem | Contour Technology<br>Muscle Stimulator | Predicate:<br>Compex Sport | Predicate:<br>ValMed P4-Fitness | Predicate:<br>Slendertone Flex 515 |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K111476 | K011880 | K031611 | K030708 |
| Indications for<br>Use | The Contour Technology<br>Muscle Stimulator is<br>intended to stimulate<br>healthy muscles in order<br>to improve or facilitate<br>muscle performance. The<br>Contour Technology<br>Muscle Stimulator may<br>therefore be considered a<br>technique or method for<br>muscle training.<br>The Contour Technology<br>Muscle Stimulator Ab<br>Belt accessory is intended<br>for use on abdominal<br>muscles only for<br>strengthening and toning<br>of abdominal muscles.<br>The Contour Technology<br>Muscle Stimulator<br>BackPad accessory is<br>intended for use on the<br>lower back muscles only. | "Compex®<br>Sport" is<br>intended to<br>stimulate healthy<br>muscles in order<br>to improve or<br>facilitate muscle<br>performance.<br>"Compex®<br>Sport" is not<br>intended to be<br>used in<br>conjunction with<br>therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. None of the<br>"Compex®<br>Sport" training<br>programs is<br>designed for<br>injured or ailing<br>muscles and its<br>use on such<br>muscles is<br>contraindicated.<br>The "Compex®<br>Sport" electrical<br>impulses allow<br>triggering action<br>potentials on | The P4-Fitness is<br>intended for<br>stimulation of healthy<br>muscles in order to<br>enhance and facilitate<br>improved muscle<br>performance. The P-4<br>Fitness is therefore<br>properly considered as<br>a technique or method<br>for muscle training.<br>The P4-Fitness is NOT<br>intended for use in any<br>therapy or for<br>treatment of any<br>medical conditions or<br>diseases. The P4-<br>Fitness training<br>programs are not<br>designed or intended<br>for injured or<br>otherwise impaired<br>muscles and use of the<br>P4-Fitness on such<br>muscles is<br>contraindicated. | The improvement of<br>abdominal muscle tone,<br>for the strengthening of<br>abdominal muscles and<br>for the development of a<br>firmer abdomen. |
| Item | Contour Technology<br>Muscle Stimulator | Predicate:<br>Compex Sport | Predicate:<br>ValMed P4-Fitness | Predicate:<br>Slendertone Flex 515 |
| | | motoneurones of<br>motor nerves<br>(excitations). The<br>excitations of<br>motoneurones are<br>transmitted to the<br>muscle fibers via<br>the motor<br>endplate hwere<br>they generate<br>mechanical<br>muscle fiber<br>responses that<br>correspond to<br>muscle work.<br>Depending on the<br>parameters of the<br>electrical<br>impulses (pulse<br>frequency,<br>duration of<br>contraction,<br>duration of rest,<br>total session<br>duration),<br>different types of<br>muscle work can<br>be imposed on the<br>stimulated<br>muscles.<br><br>The various types<br>of muscles work<br>that "Compex®<br>Sport" can<br>impose on the<br>stimulated<br>muscles are able<br>to improve or<br>facilitate muscle<br>performance.<br>"Compex®<br>Sport" may<br>therefore be<br>considered a<br>technique of<br>muscle training. | | |
| Powered<br>Muscle<br>Stimulator | YES | YES | YES | YES |
| Battery<br>operated | Four (4) 1.5V only (AAA)<br>alkaline | One (1) NIMH<br>Rechargeable<br>battery (7.2V<br>=1200mA/h) | One-9V lithium,<br>alkaline or NiMh<br>battery | Three (3) AAA 1.5V DC<br>batteries |
| Regulated | YES | YES | YES | YES |
| Item | Contour Technology<br>Muscle Stimulator | Predicate:<br>Compex Sport | Predicate:<br>ValMed P4-Fitness | Predicate:<br>Slendertone Flex 515 |
| Current /<br>Voltage | | | | |
| Plastic Housing<br>Materials | YES | YES | YES | YES |
| Maximum<br>Current Density | 0.55 mA (rms) / cm²<br>(Smallest size electrode<br>40.5cm²) | 4mAmp/cm² | 1 mA (rms)/ cm²<br>If electrode impedance<br>is <100 Ω<br>smallest size electrodes<br>ø 3.2 cm=10cm² | Information Not<br>Available |
| Independent<br>channels with<br>possibility to<br>regulate the<br>current<br>individually | YES | YES | YES | YES |
| Pulse Duration<br>(Width) | 340 μs | 200 and 400 μs | 200μs or 240μs<br>for upper extremities<br>320 μs or 340μs for<br>legs | Positive: 200-300 μs<br>Interphase: 100 μs<br>Negative: 200-300 μs |
| Frequency | 1 to 120 Hz | 1 to 120 Hz | 1 to 120 Hz | 45-77 Hz |
| Reusable Gel<br>pads | YES | YES | YES | YES |

### Table 1: Technological Characteristics comparison

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.

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The technological characteristics, features, specifications, materials, and indications for use of the Contour Technology Muscle Stimulator are substantially equivalent to the predicate devices.

Therefore, there are no new safety and efficacy issues raised with the Contour Technology Muscle Stimulation Device.

### 5.1.9 Brief Description of non-clinical tests

Non-clinical tests were performed for the Contour Technology Muscle Stimulator and a summary is provided in Table 2.

| Test |
|-------------------------------------------------------|
| System and Software Requirements Verification Testing |
| Environmental Testing |
| Safety Testing |
| Unit & Integration Testing |
| ESD / EMI Testing |
| Stress Testing |
| Shipping Testing |
| Simulated Use Testing (Usabililty Testing) |

| | Table 2: Summary of Non-Clinical Tests | | | |
|--|----------------------------------------|--|--|--|
|--|----------------------------------------|--|--|--|

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The performance data demonstrates that the device meets all the product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing.

### 5.1.10 Brief Description of clinical performance data

No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body.

### 5.1.11 Conclusion

The Contour Technology Muscle Stimulator is substantially equivalent to the predicate devices. Test results demonstrate that the device is safe and effective for its intended use and the results support determination of substantial equivalence.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

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

MAY 2,3 2012

Contour Technology % Libra Medical, Inc. Ms. Sara Petrie 8401 73rd Avenue North, Suite 63 Minneapolis, Minnesota 55428

Re: K111476

Trade/Device Name: Contour Technology Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: May 01, 2012 Received: May 02, 2012

Dear Ms. Petrie:

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

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### Page 2 - Ms. Sara Petrie

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson | -Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 4. INDICATIONS FOR USE STATEMENT

### Indications for Use

510(k) Number (if known): K111476

Device Name: Contour Technology Muscle Stimulator

#### Indications for Use:

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.

The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.

The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K111476