MODEL PM3030

K110068 · Omron Healthcare, Inc. · NUH · Dec 8, 2011 · Neurology

Device Facts

• Record ID: K110068
• Device Name: MODEL PM3030
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Dec 8, 2011
• 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, or legs due to strain from exercise or normal household and work activities.

Device Story

PM3030 is a battery-operated, single-channel TENS device for OTC pain relief. It delivers biphasic, rectangular electrical pulses to the skin via electrode pads. The device features three output modes for application to the shoulder/arm, lower back, and leg/foot. Operated by the patient in home, clinic, or hospital settings, the device uses a microprocessor to control stimulation parameters. The user adjusts output levels via a control interface. By providing electrical stimulation, the device aims to alleviate muscle pain. Safety features include automatic overload, no-load, and shut-off functions. The device is powered by two AAA batteries.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical output characterization and compliance with IEC 60601-1 and IEC 60601-1-2 safety standards. Patient-contacting materials were tested per ISO 10993-1.

Technological Characteristics

Battery-powered (2x AAA) TENS device; single-channel; biphasic rectangular waveform; frequency < 100 Hz. Housing material: ABS. Microprocessor-controlled with automatic overload, no-load, and shut-off safety features. Electrode compliance with 21 CFR 898. Patient-contacting materials tested per ISO 10993-1. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for adult patients for temporary relief of pain in lower back, arms, or legs caused by exercise or household/work strain. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices; do not use with life-supporting medical electronic devices (e.g., artificial heart/lung) or body-worn medical devices (e.g., ECG).

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

• Endurance Therapeutics, Model T1040 (K060846)

Submission Summary (Full Text)

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Omron OTC TENS

#### Premarket Notification 510(k) Section 5 - 510(k) Summary

# 510(k) Summary Page 1 of 6 7-Jan-11

| Omron Healthcare, Inc.<br>1200 Lakeside Dr.<br>Bannockburn, IL 60015 | Tel - 847-247-5626 |
|----------------------------------------------------------------------|------------------------------------------------------------------------------|
| | Fax - 847-680-6911 |
| Official Contact: | Mirna DiPano - Director of Quality & Regulatory |
| Proprietary or Trade Name: | PM3030 |
| Common/Usual Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous, over-the-counter<br>21 CFR 882.5890 |
| Device: | PM3030 |
| Predicate Devices: | Endurance Therapeutics, Model T1040, 510(k) K060846 |

#### Device Description:

The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use.

The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The specifications of each mode will be discussed in greater detail later in this section.

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.

The device has been tested to and meets the requirements of the following recognized consensus standards:

- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995

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#### Omron OTC TENS

#### 510(k) Summary Page 2 of 6 7-Jan-11

- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic:Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
#### Indications for Use:

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

Environment of Use: Clinics, hospital and home environments

#### 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.
- · Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.
- · Do not use this device together with a body-worn medical electronic device such as an ECG.

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Premarket Notification 510(k) Section 5 – 510(k) Summary

# Omron OTC TENS

# 510(k) Summary Page 3 of 6 7-Jan-11

# Summary of substantial equivalence

| Attribute | Model PM3030 | Predicate |
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Endurance Model T1040 |
| | | K060846 |
| Product Code | NUH | NUH, NGX, GZX |
| CFR | 882.5890 | 882.5890, 890.5850 |
| Indications for Use | This device is intended<br>for 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<br>exercise or normal<br>household and work<br>activities. | To be used for temporary relief of<br>pain associated with sore and aching<br>muscles in the<br>lower back due to strain from<br>exercise or normal household work<br>activities choose<br>Manual modes 1, 2, 3, 4, 5, 6 or<br>Auto 4<br>To be used for temporary relief of<br>pain associated with sore and aching<br>muscles in the<br>upper extremities (arm) due to strain<br>from exercise or normal household<br>work activities<br>choose Manual modes 1, 2, 3, 4, 5,<br>6 or Auto 1 or Auto 3<br>To be used for temporary relief of<br>pain associated with sore and aching<br>muscles in the<br>lower extremities (leg) due to strain<br>from exercise or normal household<br>work activities<br>choose Manual modes 1, 2, 6 or<br>Autol or Auto 4<br>Used to stimulate healthy muscles<br>in order to improve and facilitate<br>muscle<br>performance choose Manual Mode<br>1 or Auto Mode 2<br>Prescription |
| Patient Population | Adult | Not specified |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Not specified |
| Contraindications - do not use if you have a cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device | Yes | Yes |
| Warnings standard | Yes | Yes |
| Precautions - standard | Yes | Yes |
| Adverse reactions - standard | Yes | Yes |
| Power source | 2 - AAA | 3 - AAA |
| Number of Output modes | 3 | 10 |
| Number of output channels | 1 | 1 |
| Waveform | Biphasic | |
| Shape | Rectangular | |
| Maximum Output Voltage (max) | | |
| 500 ohm | 35.4 V | 40.7 |
| 2k ohm | 46.7 V | 105.1 |
| 10k ohm | 50.8 V | 154.1 |
| Maximum Output Current (max) | | |
| 500 ohm | 4.4 mA | 81.4 |
| 2k ohm | 1.7 mA | 47.8 |
| 10k ohm | 0.4 mA | 15.4 |
| Maximum Phase charge (500 ohm) | 133 microC | 16.9 microC |
| Maximum Current Density (500 ohm) | 0.095 mA/cm² | 2.71 mA/cm² |
| Maximum Average Current (500 ohm) | 3.5 mA | Not specified |
| Maximum Average Power Density (500 ohm) | 89 mW/cm² | 10.2 mW/cm² |
| Frequency (Hz) | < 100 Hz | 245 Hz |
| Burst Mode | None | |
| Timer range (min) | 15 minutes | 30 minutes |
| Indication display | | |
| On/Off status | Yes | Yes |
| Low battery | No | Yes |
| Voltage / Current level | Yes | Yes |
| Output mode | Yes | Yes |
| Time to cut-off | No | Yes |
| Dimensions | 55 mm x 95 mm x 19 mm | 150 mm x 68 mm x 26 mm |
| Weight | 60 grams | 90 grams |

.

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# Premarket Notification 510(k) Section 5 – 510(k) Summary

.

# Omron OTC TENS

... : : : : .. : ..

# 510(k) Summary

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... ... ... ... ... ... ... ... ... ... ... .............................................................................................................................

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#### Omron OTC TENS

#### 510(k) Summary Page 5 of 6 7-Jan-11

| Housing material | ABS | Not specified |
|--------------------------------------|---------------------|---------------|
| Microprocessor control | Yes | Yes |
| Automatic Overload trip | Yes | Not specified |
| Automatic no-load trip | Yes | Not specified |
| Automatic shut-off | Yes | Not specified |
| User override control | Power On/Off button | Not specified |
| Electrode compliance with 21 CFR 898 | Yes | Not specified |
| Electrode cable | Yes | Yes |

# Differences Between Other Legally Marketed Predicate Devices

The Omron PM3030 OTC TENSis viewed as substantially equivalent to the predicate device because: The electrical stimulation provided by the PM3030 is substantially equivalent to that commonly employed by TENS devices that have been cleared for marketing without prescription labeling; i.e., for OTC sale. The pulses in the waveform combinations are restricted in amplitude and duration to values consistent with other cleared devices.

Technological characteristics, features, specifications, materials and intended uses of the PM3030 are substantially equivalent to the quoted predicate devices.

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

#### Indications -

The PM3030 and the predicate (Endurance Model T1040 K060846) are for the temporary relief of pain associated with sore and aching muscles in the upper and lower extremities and lower back due to strain from exercise or normal household and work activities and we view them as equivalent. Performance testing has been performed that shows equivalent waveform characteristics.

# Technology -

- Identical both the PM3030 and the predicate provide electrically generated pulses . applied to the skin via electrodes.
# Operating specifications -

- Equivalent. Section 12 provides detailed descriptions of the characteristics of the . PM3030 and the predicate. They are equivalent.

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Premarket Notification 510(k) Section 5 – 510(k) Summary

### Omron OTC TENS

# 510(k) Summary. Page 6 of 6 7-Jan-11

# Materials –

- The patient contacting materials of the electrode has been tested in accordance to . ISO 10993-1 and FDA Guidance.
Environment of Use -

- Both are OTC devices so assume same environment .
# Patient Population -

- . PM3030 is restricted to adults

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

#### Public Health Service

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

DEC = 8 2011

Omron Healthcare, Inc. c/o Mr. Paul E. Dryden President, Regulatory Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K110068

Trade/Device Name: Model PM3030 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: October 25, 2011 Received: October 26, 2011

Dear Mr. Dryden:

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 E. 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 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/ResourcesforYou/Industry/default.htm.

on

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

Sincerely yours,
Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

Page 1 of 1

510(k) Number:

(To be assigned)

Device Name:

Model PM3030

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) or

Over-the-counter use XX (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mussla L. Burke Nicholas
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110068