MAXPOWER RELIEF

K141978 · Omron Healthcare, Inc. · NUH · Dec 3, 2014 · Neurology

Device Facts

• Record ID: K141978
• Device Name: MAXPOWER RELIEF
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities.

Device Story

Maxpower relief (PM3032) is a battery-operated, single-channel TENS device for OTC pain relief. It delivers biphasic, rectangular electrical pulses to muscles via electrode pads. The device features 9 output modes with adjustable voltage/current levels and timer settings. It is intended for use in clinics, hospitals, and home environments by adult patients. The device is controlled by an internal microprocessor that manages waveform characteristics and safety features, including an automatic no-load trip that stops stimulation if pads are not properly adhered. Users operate the device via an On/Off control and monitor status via an indicator display. The device provides symptomatic pain relief by stimulating muscles, potentially reducing discomfort from strain.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including electrical safety (AAMI ANSI ES60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), and usability testing. Biocompatibility of patient-contacting materials (Long Life Pads) was established via reference to K120516.

Technological Characteristics

Battery-operated (2x AAA) TENS device; single-channel; biphasic rectangular waveform; microprocessor-controlled. Complies with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Patient-contacting materials (Long Life Pads) tested per ISO 10993-5 and ISO 10993-10. Dimensions: ~52x112x25mm; Weight: ~100g.

Indications for Use

Indicated for adults for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household and work activities. Contraindicated for use with pacemakers, implanted metallic/electronic devices, life-supporting medical electronic devices (e.g., artificial heart/lung, respirator), in the presence of monitoring equipment, with high-frequency surgical units, in close proximity to shortwave/microwave therapy equipment, or with another TENS device.

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

• Omron PM3030 (K110068)
• Healthmate International Pro-8AB (K121757)

Reference Devices

• Long Life Pads (K120516)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of a human figure, with the head, torso, and legs represented by curved lines.

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

MAR 16 2015

Omron Healthcare, Inc. % Paul Dryden Consultant ProMedic. Inc. 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K141978

> Trade/Device Name: Maxpower relief (PM3032) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 19, 2014 Received: October 21, 2014

Dear Mr. Dryden,

This letter corrects our substantially equivalent letter of December 3, 2014.

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.

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Page 2 - Mr. Paul Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## Felipe Aquel -S

Carlos L. Peña, PhD, MS Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

#### Device Name

Maxpower relief (PM3032) Indications for Use (Describe)

> This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities.

Environments of Use: Clinics, hospital and home environments

Patient Population: Adult

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 510(k) Summary Page 1 of 9 1/30/2015

| Omron Healthcare, Inc.<br>1925 West Field Court<br>Lake Forest, IL 60045 USA | Tel - 847-247-5626<br>Fax- 847-680-6269 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Official Contact: | Renee Thornborough - Director QA/RA |
| Proprietary or Trade Name: | PM3032 |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain<br>relief. |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous,<br>over-the-counter<br>21CFR 882.5890<br>Class II |
| Device Name: | Maxpower relief |
| Predicate Devices: | K110068 - Omron - PM3030<br>K121757 - Healthmate International - Pro8AB |

Device Description:

The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.

The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The specifications of each mode will be discussed in greater detail later in this section.

Software controls all controls and indicators. Software controls waveform characteristics.

This device is intended for the relief of pain associated with sore or aching, muscles of the shoulder, lower back, arms, or legs due to strain from exercise or normal household and work activities.

The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part.

As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.

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### 510(k) Summary Page 2 of 9 1/30/2015

We have provided the information suggested in Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use from April 5, 2010. A checklist in accordance with this guidance can be found in Section 18 of this submission

### Intended User OTC

# Patient Population

Adults

## Indications for Use:

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities.

## Environment of Use:

Clinics, hospital and home environments

## Contraindications:

- Use with a pacemaker or other implanted metallic or electronic device. ●
- Use with a life-supporting medical electronic device such as an artificial heart or . lung or respirator
- Use in the presence of monitoring equipment (e.g. cardiac monitors, ECG alarms) ●
- Simultaneous connection of a patient to a high frequency surgical unit ●
- Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy . equipment
- . Use with another TENS device

## Predicate Device Comparison:

The Maxpower relief (PM3032) was compared to the predicates PM3030- K110068 and Healthmate Pro-8B - K121757 in the device comparison Table 5.1 below. Detailed electrical characteristics are provided in Table 5.2.

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#### Table 5.1 Device Comparison

:

| Model Name<br>510(k) Number | New Device<br>Maxpower relief (PM3032) | Predicate Device<br>PM3030<br>K110068 | Predicate Device<br>Pro-8AB<br>K121757 | Comment |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Manufacturer | OMRON HEALTHCARE | OMRON HEALTHCARE | Healthmate International | |
| Indications for use | This device is intended for the<br>relief of pain associated with<br>sore or aching muscles of the<br>lower back, arms, legs,<br>shoulder or foot due to strain<br>from exercise or normal<br>household and work activities. | This device is intended for<br>the relief of pain<br>associated with sore or<br>aching, muscles of the<br>lower back, arms, or legs<br>due to strain from exercise<br>or normal household and<br>work activities. | To be used for temporary<br>relief of pain with sore<br>and aching muscles in the<br>shoulder, waist, back,<br>neck upper<br>extremities(arm), and<br>lower extremities(leg).<br>due to strain from exercise<br>or normal household work<br>activities. | Substantially<br>equivalent |
| Prescriptive | No, OTC | No, OTC | No, OTC | Identical |
| Power Source(s) | two AAA alkaline batteries | two AAA alkaline batteries | Rechargeable battery | PM3030 and<br>PM3032 identical |
| - Method of Line Current Isolation | N.A. not line powered | N.A. not line powered | N.A. not line powered | Identical all battery<br>powered |
| Patient Leakage Current - Normal<br>Condition (uA) | 1 | <0.1 | Not specified | All three device<br>comply with<br>60601-1 leakage<br>current<br>requirements |
| Patient Leakage Current - Single Fault<br>Condition (uA) | 8.9 max with mains<br>(250vAC/60Hz) | N.A | Not specified | All three device<br>comply with<br>60601-1 leakage<br>current<br>requirements |

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| 510(k) Summary<br>Page 4 of 9<br>1/30/2015 | | | | | |
|---------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------------------|--|
| Model Name<br>510(k) Number | New Device<br>Maxpower relief (PM3032) | Predicate Device<br>PM3030<br>K110068 | Predicate Device<br>Pro-8AB<br>K121757 | Comment | |
| Average DC current through electrodes<br>when device is on but no pulse are<br>being applied (uA) | 0 (uA) | 0 (uA) | 0 (uA) | Identical | |
| Number of output Modes | 9 | 3 | 8 | | |
| Number of output<br>channels | 1 ch | 1 ch | 2 ch | PM3030 and<br>PM3032 identical | |
| Method of Channel<br>Isolation | None, single channel | None, single channel | Not specified | PM3030 and<br>PM3032 identical | |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Not specified | PM3030 and<br>PM3032 identical | |
| Software/Firmware/Microprocessor<br>Control | Microprocessor | Microprocessor | Not specified | PM3030 and<br>PM3032 identical | |
| Automatic Overload Trip | No | No | Not specified | PM3030 and<br>PM3032 identical | |
| Automatic No-Load Trip | Yes | No | No | PM3032 contains<br>circuit which will<br>stop stimulation if<br>pads are not<br>properly adhered | |
| Automatic shut Off | Yes | Yes | Yes | Identical | |
| User over ride control | User activated On/Off | User activated On/Off | User activated On/Off | Identical | |

,

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| Model Name<br>510(k) Number | New Device<br>Maxpower relief (PM3032) | Predicate Device<br>PM3030<br>K110068 | Predicate Device<br>Pro-8AB<br>K121757 | Comment | |
|-------------------------------------|----------------------------------------|------------------------------------------------------------------|----------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------|
| Indication display | ON/Off status | Yes | Yes | Yes | Identical |
| | Low Battery | Yes | No | Yes | PM3032 and<br>Pro-8AB identical |
| | Voltage/Current<br>Level | Yes | Yes | Yes | Identical |
| Timer Range (minutes) | | 15 | 15 | 10-60 | |
| Compliance with Voluntary standards | | ES 60601-1, IEC 60601-1-2,<br>IEC 60601-2-10, IEC 60601-<br>1-11 | IEC 60601-1, IEC 60601-<br>1-2 | IEC 60601-1, IEC<br>60601-1-2, IEC 60601-<br>2-10 | PM3032 complies<br>with currently<br>recognized version of<br>60601-1 |
| Compliance with 21 CFR 898 | | Yes (by compliance with<br>8.5.2.3 of ES 60601-1) | Yes | Not specified | PM3032 and PM3030<br>identical |
| Weight | | Approx. 100g (incl. batteries) | Approx. 60g (incl.<br>batteries) | Approx. 54g (incl.<br>batteries) | Similar |
| Dimensions (W x H x D) | | 52(W)x112(H)x25(D)mm | 55(W)x95(H)x18(D) | 50(W)x93(H)x10(D) | Similar |
| Patient contact | | Long Life Pads | Long Life Pads | Not specified | Identical electrode<br>pads. The Long Life<br>Pads (K120516) |

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# Table 5.2 Detailed Electrical Comparisons Maxpower relief (PM303) Compared on Predicate Pro-8AB K121757
Press Presses Previous Max Previous Max power

| Parameter | Maxpower relief (P13032) | | | | | | | | Predicate Pro-8AB K121757 | | | | | | | | | |
|--------------------------------------------------|------------------------------------|-------------|-------------|-------------|-------------|-------------|-------------|-----------------|---------------------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|------|
| Mode of Program Name | TAP | KNEAD | RUD | ARM | LBACK | LEG | FOOT | JOINT | SHLDR | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum<br>Output<br>Voltage [V] | @500Ω<br>66.3 | 51.1 | 42.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 43.9 | 54.0 | 85.8 | 41.9 | 42.0 | 83.9 | 44.0 | 85.9 | |
| | @2kΩ<br>87.6 | 67.9 | 55.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 81.9 | 102.0 | 145.9 | 77.8 | 79.9 | 145.6 | 83.9 | 145.4 | |
| | @10kΩ<br>95.9 | 73.9 | 59.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 146.4 | 159.9 | 159.8 | 137.0 | 141.7 | 158.1 | 147.8 | 159.9 | |
| Maximum<br>Output<br>Current [mA] | @500Ω<br>132.6 | 102.2 | 84.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 87.8 | 108.0 | 171.6 | 83.8 | 84.0 | 167.8 | 88.0 | 171.8 | |
| | @2kΩ<br>43.8 | 34.0 | 28.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 41 | 51.0 | 73.0 | 38.9 | 40.0 | 72.8 | 42.0 | 72.7 | |
| | @10kΩ<br>9.6 | 7.4 | 6.0 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 14.6 | 16.0 | 16.0 | 13.7 | 14.2 | 15.8 | 14.8 | 16.0 | |
| Duration of primary phase [usec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | |
| Pulse Duration [usec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | |
| Frequency [Hz] | 1-15.43 | 25.28-79.22 | 84.86-132 | 1-132 | 1-237.6 | 1-19.16 | 1-19.16 | 42.43-<br>237.6 | 1-19.16 | 59 | 12-47 | 1.7 | 95 | 94 | 1.7-59 | 59 | 1.7-94 | |
| For<br>multiphasic<br>waveforms<br>only: | Symmetric<br>al phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| | Phase<br>Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Net Charge(μC per pulse)<br>(@500Ω) [μC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
| Maximum Phase Charge<br>(@500Ω) [μC] | 13.26 | 15.33 | 12.69 | 13.26 | 19.89 | 13.26 | 13.26 | 13.26 | 13.26 | 7.9 | 9.72 | 15.44 | 7.54 | 7.56 | 15.10 | 7.92 | 15.46 | |
| Maximum Current Density<br>(@500Ω) [mA/cm²] | 3.03 | 2.33 | 1.93 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.38 | 4.16 | 6.62 | 3.23 | 3.24 | 6.47 | 3.39 | 6.62 | |
| Maximum Average Current<br>(@500Ω) [mA] | 0.17 | 0.37 | 0.71 | 0.83 | 0.38 | 0.43 | 0.17 | 0.22 | 0.88 | 0.47 | 0.46 | 0.03 | 0.72 | 0.71 | 0.89 | 0.47 | 1.45 | |
| Maximum Average Power<br>Density (@500Ω) [W/cm²] | 0.00017 | 0.00020 | 0.00039 | 0.00060 | 0.00015 | 0.00040 | 0.00016 | 0.00015 | 0.00082 | 0.00079 | 0.00095 | 0.00004 | 0.00116 | 0.00115 | 0.002 | 0.00079 | 0.00142 | |
| Burst<br>Mode | (a) Pulses per<br>burst | 46 | 71 | 118 | 23 | 1425 | 57 | 57 | 1425 | 76 | 159 | 940 | N/A*** | 66 | 1786 | 940 | 295 | 1767 |
| | (b) Bursts per sec | 0.33 | 0.59 | 0.59 | 1.00 | 0.14 | 0.25 | 0.25 | 0.14 | 0.20 | 0.24 | 0.05 | N/A*** | 0.87 | 0.04 | 0.05 | 0.15 | 0.05 |
| | **(c) Burst<br>duration | 3 | 8.5 | 17 | 8 | 14 | 8 | 8 | 14 | 10 | 4.2 | 21.1 | N/A*** | 1.15 | 23 | 21.17 | 6.6 | 20.5 |
| | (d) Duty cycle:<br>Line(b)xLine(c) | 1 | 5 | 10 | 8 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | N/A*** | 1 | 1 | 1 | 1 | 1 |
| ON Time (seconds) | 3 | 0.9 | 0.9 | 0.3 | 6 | 3 | 3 | 6 | 4 | 2.7 | 20 | N/A*** | 0.7 | 19 | 20 | 5 | 18.8 | |
| OFF Time (seconds) | 0 | 0.8 | 0.8 | 0.7 | 1 | 1 | 1 | 1 | 1 | 1.5 | 11 | N/A*** | 0.45 | 4 | 1.17 | 1.6 | 1.7 | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |

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## Output Specifications Maxpower relief (PM3032) Compared to Predicate PM3030 K110068

| Parameter | Maxpower relief (PM3032) | | | | | | | Predicate PM3030 K110068 | | | | | |
|--------------------------------------------------|------------------------------------|-------------|-------------|-------------|-------------|-------------|-------------|--------------------------|-------------|-------------|-----------------|---------------|---------|
| Mode of Program Name | TAP | KNEAD | RUB | ARM | LBACK | LEG | FOOT | JOINT | SHLDR | Arm Mode | Lower Back Mode | Leg/foot Mode | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output<br>Voltage [V] | @500Ω | 66.3 | 51.1 | 42.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 34.4 | 33.0 | 34.2 |
| | @2kΩ | 87.6 | 67.9 | 55.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 46.0 | 43.2 | 45.2 |
| | @10kΩ | 95.9 | 73.9 | 59.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 49.6 | 48.0 | 50.4 |
| Maximum Output<br>Current [mA] | @500Ω | 132.6 | 102.2 | 84.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 68.8 | 66.0 | 68.4 |
| | @2kΩ | 43.8 | 34.0 | 28.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 23.0 | 21.6 | 22.6 |
| | @10kΩ | 9.6 | 7.4 | 6.0 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 5.0 | 4.8 | 5.0 |
| Duration of primary phase [μsec] | | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| Pulse Duration [μsec] | | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| Frequency [Hz] | | 1 - 15.43 | 25.28-79.22 | 84.86-132 | 1 - 132 | 1 - 237.6 | 1 - 19.16 | 1 - 19.16 | 42.43-237.6 | 1 - 19.16 | 2 - 51.65 | 2 - 108 | 2 - 11 |
| For multiphasic<br>waveforms only | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| | Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Net Charge(μC per pulse) (@ 500Ω) [μC] | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum Phase Charge (@500Ω) [μC] | | 13.26 | 15.33 | 12.69 | 13.26 | 19.89 | 13.26 | 13.26 | 13.26 | 13.26 | 6.88 | 6.60 | 6.84 |
| Maximum Current Density (@500Ω) [mA/cm²] | | 3.03 | 2.33 | 1.93 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 1.57 | 1.51 | 1.56 |
| Maximum Average Current (@500Ω) [mA] | | 0.17 | 0.37 | 0.71 | 0.83 | 0.38 | 0.43 | 0.17 | 0.22 | 0.88 | 0.29 | 0.58 | 0.07 |
| Maximum Average Power Density (@500Ω)<br>[W/cm²] | | 0.00017 | 0.00020 | 0.00039 | 0.00060 | 0.00015 | 0.00040 | 0.00016 | 0.00015 | 0.00082 | 0.00018 | 0.00035 | 0.00005 |
| Burst Mode | (a) Pulses per burst | 46 | 71 | 118 | 23 | 1425 | 57 | 57 | 1425 | 76 | 180 | 540 | 33 |
| | (b) Bursts per second | 0.33 | 0.59 | 0.59 | 1.00 | 0.14 | 0.25 | 0.25 | 0.14 | 0.20 | 0.11 | 0.10 | 0.17 |
| | **(c) Burst duration | 3 | 8.5 | 17 | 8 | 14 | 8 | 8 | 14 | 10 | 18 | 20 | 6 |
| | (d) Duty cycle:<br>Line(b)xLine(c) | 1 | 5 | 10 | 8 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 |
| ON Time (seconds) | | 3 | 0.9 | 0.9 | 0.3 | 6 | 3 | 3 | 6 | 4 | 8 | 10 | 6 |
| OFF Time (seconds) | | 0 | 0.8 | 0.8 | 0.7 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
| Additional Features | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |

(**): Burst duration = pulse train duration
(***): Burst duration = pulse train duration
(***): Endurande model Automode I doesn't have a burst mode

(*) burn duration = pulse train duration

(***): Endurmeds model Automode I doesn't have a built like those.

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### 510(k) Summary Page 8 of 9 1/30/2015

### Differences Between Other Legally Marketed Predicate Devices:

The Omron Maxpower relief (PM3032) is viewed as substantially equivalent to the predicate devices because: The Maxpower relief (PM3032) uses the exact same technology and has substantially equivalent indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

### Indications -

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulder or foot due to strain from exercise or normal household and work activities. These indications are virtually identical to the predicates.

Prescriptive - The Maxpower relief (PM3032) and predicates are all OTC.

Design and Technology - The Maxpower relief (PM3032) has equivalent design and features when compared to the predicates and has the identical technology to the predicate PM3030.

Performance and Specifications - The Maxpower relief (PM3032) has equivalent specifications of performance when compared to the predicates.

Compliance with standards - The predicate devices declare compliance with IEC 60601-1 and IEC 60601-1-2. The PM3032 complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1) and IEC 60601-1-2. The Pro-8AB and PM3032 comply with IEC 60601-2-10. Additionally the PM3032 complies with IEC 60601-1-11 for home healthcare.

### Materials -

The patient contacting materials of the Maxpower relief (PM3032) are the Long Life Pads. The Long Life Pads and were tested and the data presented in K 120516.

- Irritation and delayed-type hypersensitivity Extract in accordance with ISO 10993-10 .
- Closed-patch test for delayed hypersensitivity Rabbits in accordance with ISO . 10993-10
- Cytotoxicity in accordance with ISO 10993-5

### Patient Population -

The Maxpower relief (PM3032) and predicates are indicated for adults

Environment of Use - Clinics, hospital and home environments. Identical to the predicate K110068

### Non-Clinical Testing Summary:

The device has been tested to insure that all requirements have been met, this includes:

- . Testing of all controls

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### 510(k) Summary Page 9 of 9 1/30/2015

- Testing of all indicators .
- . Testing of battery state indicators
- Testing of waveforms ●

The device has also been tested to the requirements of the following standards:

- AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: . general requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility -Requirements and Tests
- . 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
- IEC 60601-2-10: 2012 Medical electrical equipment part 2-10: particular . requirements for the basic safety and essential performance of nerve and muscle stimulators

The device has also been tested for drop, vibration and environmental temperature and humidity

Usability testing has also been performed.

### Clinical Testing Summary:

No clinical testing was performed

### Substantial Equivalence Conclusion

Omron maintains that the Maxpower relief (PM3032)is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.