Focus TENS Therapy, Model PM710-M/-L

K183215 · Omron Healthcare, Inc. · NUH · Sep 7, 2019 · Neurology

Device Facts

• Record ID: K183215
• Device Name: Focus TENS Therapy, Model PM710-M/-L
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Sep 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments. Patient Population: Adult.

Device Story

Wearable, rechargeable electrotherapy device delivering TENS (Transcutaneous Electrical Nerve Stimulation) to alleviate chronic, acute, and arthritic leg pain. Device consists of a main unit, gel, and band (medium/large) for attachment below the knee. Operates via control buttons on the main unit; intensity displayed by LED indicators. Used in clinics, hospitals, or home by adults. Device generates biphasic, rectangular waveforms to produce rhythmic muscle contractions, promoting vasodilation, reducing edema, and enhancing oxygen/nutrient supply to joints. Healthcare providers/patients use output to manage pain and discomfort. Benefits include non-pharmacological pain relief and improved local circulation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including output waveform analysis, pad adhesion, electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility, and usability testing.

Technological Characteristics

Wearable TENS device; rechargeable lithium-ion battery; biphasic, rectangular waveform; single-channel output. Materials: reusable self-adhesive contouring pads. Connectivity: standalone (no app). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11. Sterilization: non-sterile.

Indications for Use

Indicated for adult patients for relief of pain associated with sore or aching muscles of the lower extremities (leg) due to exercise or household work, and for symptomatic relief and management of chronic, intractable pain associated with arthritis. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

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 Avail Wireless Dual Channel TENS PM601 (K172079)

Reference Devices

• Neurometrix, Inc. Quell (K152954)
• Shenzhen Roundwhale Technology Co., Ltd Model R-T1 TENS stimulator (K180956)

Submission Summary (Full Text)

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September 7, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

Omron Healthcare, Inc. % Ronald Warren Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110

Re: K183215

Trade/Device Name: Focus TENS Therapy, Model PM710-M/-L Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: August 5, 2019 Received: August 6, 2019

Dear Ronald Warren:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

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### Page

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Robert Kang, PharmD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K183215

Device Name Omron Focus TENS Model PM710-M/-L

Indications for Use (Describe)

The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities.

It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. 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)

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### 510(k) Notification K183215

### GENERAL INFORMATION [807.92(a)(1)]

### Applicant:

Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: [phone] FAX: [phone]

### Contact Person:

Ronald S. Warren Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] FAX: [phone]

### Date Prepared: December 11, 2018

### DEVICE INFORMATION [807.92(a)(2)]

### Trade Name:

Focus TENS Model PM710-M/-L

### Generic/Common Name:

Transcutaneous Electrical Nerve Stimulator for Pain Relief

### Classification:

Class II per 21CFR882.5890

### Product Code:

NUH and NYN

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### PREDICATE DEVICE(S) [807.92(a)(3)]

The Omron Focus TENS Model PM710-M/-L ("PM710") is substantially equivalent to the predicate device, the Omron Avail Wireless Dual Channel TENS PM601 (K172079), with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. In addition, the PM710 device is also similar to two other reference devices, the Neurometrix, Inc. Quell (K152954) and the Shenzhen Roundwhale Technology Co., Ltd Model R-T1 TENS stimulator (K180956) in regard to intended use and features.

### DEVICE DESCRIPTION [807.92(a)(4)]

The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee.

The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.

### INDICATIONS FOR USE [807.92(a)(5)]

The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities.

It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis.

Environments of Use: Clinics, hospital and home environments.

Patient Population: Adult.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

In regard to technological characteristics, the PM710 device is similar to the predicate Avail TENS devices in respect to the intended use and indication for use. PM710 is specifically intended for relieving pain of sore or aching muscles of the leg, whereas the Avail device is intended to relieve pain with sore or aching muscles for a wider range of body sites including the lower back, arms, legs, shoulders or feet. Both PM710 and Avail are also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis, and can be used in clinics, hospitals and home for adults.

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### 510(k) SUMMARY (CONT.)

The PM710 device offers one TENS treatment mode similar to the reference device Quell, whereas the predicate Avail device offers nine TENS treatment modes and one microcurrent mode. The waveform generated by PM710 is also different from the waveforms of the Avail system, however the electrical parameters of both are very similar. As such, the waveforms produced by PM710 and Avail can both achieve the same therapeutic outcome of "symptomatic relief and management of chronic, intractable pain as well as the discomfort associated with arthritis". This is due to the presence of:

- o High frequency (50+) Hz for chronic pain that requires non-contracting stimulation modes for a comfortable smoother therapy for chronic pain therapy.
- Modulation via different pulse trains to prevent muscle accommodation for both . chronic pain and arthritis.
- Variation of both high and low rate pulses within the mode to address both muscle o and joint pain from arthritis and various chronic pain.

The composite action of the low and high rate Hz stimulation produces rhythmic muscle contractions which then produces improved local blood vessel vasodilation thus reducing edema and retained metabolites commonly occurring from excessive muscle strain to support weak/arthritic joints. In addition, it enhances the supply of fresh oxygen and nutrients that can further result in decreased discomfort.

In regard to other output characteristics, summary tables of output parameters for the PM710, predicate and reference devices are provided in this submission. In general, the PM710 output parameters fall within the range of output parameters for the predicate Avail device. For example, the maximum current density (mA/cm2) range for PM710 is 0.97, while the Avail is 0.0008 ~ 0.17 which are both well below the IEC60601-2-10:2012 (Clause 201.4.2) limit of less than 2mA/cm². The maximum average power density (W/cm²) range is 7.59x103 for PM710, whereas the Avail maximum average power density range is 1.4x10-8 ~ 6.8x10-4, and the reference device R-T1 TENS is 1.08x10-4~1.48x10-2, which has a closer match to PM710.

In regard to treatment duration, the PM710 offers a specified timer duration for 30 minutes. For Avail, there are two selectable time ranges for TENS therapy; 5 to 60 minutes and 30 to180 minutes, depending on the selected mode. The same time duration of 30 minutes is also offered by the reference device of R-T1. In this regard, PM710 should be considered at least as the predicate and reference devices. A comparison of the PM710 output specification to the predicate device Avail and reference device R-T1 TENS are also provided in this submission.

### SUBSTANTIAL EQUIVALENCE

The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic, hospital or home settings. Omron has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the PM710 device performs as intended. The PM710 also passed testing requirements for electrical safety and EMC, and the device patient-contacting were tested to demonstrate biocompatibility. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions

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### 510(k) SUMMARY (CONT.)

of safety or effectiveness. As such, the proposed PM710 is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed PM710 device, the predicate and reference devices is included in the Substantial Equivalence Table (Table 1) below.

In regard to other technological characteristics, summary tables (Tables 2, 3 and 4) of output parameters for the PM710, predicate and reference devices are provided below.

### PERFORMANCE DATA [807.92(b)]

All necessary bench and nonclinical testing were conducted on the PM710 to support a determination of substantial equivalence to the predicate device.

### [807.92(b)(1)|Nonclinical Testing Summary:

All necessary non-clinical and usability testing was conducted on the PM710 to confirm that the device performs as intended. The nonclinical, bench testing included:

- Current Consumption
- Output Waveform
- PAD Peeling-off Detection
- Function Check
- AD Voltage Detection Accuracy
- Charging Current ●
- Voltage Endurance, Insulation Resistance ●
- Battery Characteristics
- Charger:
- 0 Current Consumption
- o Voltage Endurance, Insulation Resistance
- Durability test for the connector (between the unit and pad) ●
- Dispersion ●
- Adhesion (EC12 and Cutaneous Electrode) ●
- Adhesion on Human Skin .
- Impedance for PAD
- Battery Characteristics after Drop/Vibration Testing ●

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the PM710 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the PM710 does not raise different questions of safety or effectiveness for TENS therapy when compared to the predicate device.

### [807.92(b)(2)|Clinical Testing Summarv:

Not applicable. Clinical testing was not performed to support this 510(k) submission.

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### 510(k) SUMMARY (CONT.)

### CONCLUSIONS [807.92(b)(3)]

Based on the results from the nonclinical and usability tests performed in support of PM710, it is concluded that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate device.

### SUMMARY

The proposed device and predicate device are both intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic, hospital or home settings. Omron has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the PM710 device performs as intended. The PM710 also passed testing requirements for electrical safety and EMC, and the device patientcontacting components were tested to demonstrate biocompatibility. The minor differences in technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, PM710 is substantially equivalent to the predicate device.

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| Feature | Proposed Device<br>Focus TENS<br>PM710-M/PM710-L | Primary Predicate Device<br>Omron Avail Wireless Dual<br>Channel TENS PM601<br>K172079 | Reference Device<br>Quell<br>K152954 | Reference Device<br>Model R-T1 TENS<br>Stimulator<br>K180956 | Analysis of Technological<br>Differences |
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| Classification-<br>Regulation | 21 CFR§882.5890,<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief | 21 CFR§882.5890,<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief | No difference. Proposed<br>device and predicate device<br>have the same medical device<br>classification number. |
| Classification-<br>Product Code | Primary: NUH -<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief. Secondary: NYN-<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief. | Primary: NUH -<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief. Secondary: NYN-<br>Transcutaneous electrical<br>nerve stimulator for pain<br>relief. | NUH - Transcutaneous<br>electrical nerve stimulator<br>for pain relief | NUH - Transcutaneous<br>electrical nerve stimulator for<br>pain relief | No difference. Proposed<br>device and predicate device<br>have the same medical device<br>product code. |
| Indications for Use | The Focus TENS is<br>intended for the relief of<br>pain associated with sore<br>or aching muscles of the<br>lower extremities (leg) due<br>to strain from exercise or<br>normal household work<br>activities.<br><br>It is also intended for the<br>use of symptomatic relief<br>and management of<br>chronic, intractable pain<br>associated with arthritis. | The Avail Wireless Dual<br>Channel TENS is intended<br>for the relief of pain<br>associated with sore or<br>aching muscles of the lower<br>back, arms, legs, shoulders or<br>feet due to strain from<br>exercise or normal household<br>work activities.<br><br>When used for the<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief of<br>pain associated with arthritis,<br>choose Tap, Shoulder, Arm<br>or Leg mode. | Quell is intended for use as<br>a transcutaneous electrical<br>nerve stimulation device for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the lower<br>extremities due to strain<br>from exercise or normal<br>household and work<br>activities.<br><br>Quell is intended for use as<br>a transcutaneous electrical<br>nerve stimulation device for<br>the symptomatic relief and<br>management of chronic<br>intractable pain.<br><br>The device may be used<br>during sleep. The device is<br>labeled for use only with | This device is designed to be<br>used for temporary relief of<br>pain associated with sore and<br>aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm), and<br>lower extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities. | Similar to Avail but with<br>narrower use for knee rather<br>than the leg generally. |
| Environments of Use: | Clinics, hospital and home<br>environments | Clinics, hospital and home<br>environments | | | |
| Patient Population: | Adult | | | | |

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| Feature | Proposed Device<br>PM710-M/PM710-L | Primary Predicate Device<br>Omron Avail Wireless Dual<br>Channel TENS PM601<br>K172079<br>Patient Population: Adult | Reference Device<br>Quell<br>K152954<br>compatible NeuroMetrix<br>electrodes. | Reference Device<br>Model R-T1 TENS<br>Stimulator<br>K180956 | Analysis of Technological<br>Differences |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Environment of Use | Clinics, hospitals and home<br>environments | Clinics, hospitals and home<br>environments | Unknown | Unknown | Same as Avail |
| Patient Population | Adults | Adults | Adults | Adults | No difference. Intended for<br>same population. |
| Contraindications/Warnings/Precautions | Contraindications<br>Do not use this device if<br>you have a cardiac<br>pacemaker, implanted<br>defibrillator, or other<br>implanted metallic or<br>electronic device. Such use<br>could cause electric shock,<br>burns, electrical<br>interference, or death. | Contraindications<br>Do not use this device if you<br>have a cardiac pacemaker,<br>implanted defibrillator, or<br>other implanted metallic or<br>electronic device. Such use<br>could cause electric shock,<br>burns, electrical interference,<br>or death. | Contraindications<br>Do not use this device if you<br>have a cardiac pacemaker,<br>implanted defibrillator, or<br>other implanted metallic or<br>electronic device. Such use<br>could cause electric shock,<br>burns, electrical<br>interference, or death. | Contraindications<br>1) Do not use this device if<br>you have a cardiac<br>pacemaker, implanted<br>defibrillator, or other<br>implanted metallic or<br>electronic device. Such use<br>could cause electric shock,<br>burns, electrical interference,<br>or death.<br>2) The device should not be<br>used when cancerous lesions<br>or other lesions are present in<br>the treatment area.<br>3) Stimulation should not be<br>applied over swollen,<br>infected, inflamed areas or<br>skin eruptions (e.g. phlebitis,<br>thrombophlebitis, varicose<br>veins, etc.).<br>4) Electrode placements must<br>be avoided in the carotid<br>sinus area (anterior neck) or<br>tran-scerebrally (through the<br>head).<br>5) This device should not be<br>used in overly enervated | Same as Avail and Quell for<br>Contraindications |
| | Table 1: Substantial Equivalence Table – Regulatory Information (cont.) | | | | |
| Feature | Proposed Device<br>PM710-M/PM710-L | Primary Predicate Device<br>Omron Avail Wireless Dual<br>Channel TENS PM601,<br>K172079 | Reference Device<br>Quell<br>K152954 | Reference Device<br>Model R-T1 TENS<br>Stimulator<br>K180956 | Analysis of Technological<br>Differences |
| | | | | areas.<br>6) Inguinal hernia.<br>7) Do not use on scarred<br>areas following a surgery for<br>at least 10 months after the<br>operation.<br>8) Do not use with serious<br>arterial circulatory problems<br>in the lower limbs. | |
| Single Use | Pads are for single patient use | Pads are for single patient use | Pads are for single patient use | Pads are for single patient use | No difference. Proposed and<br>predicate devices are durable<br>medical equipment intended<br>for multiple uses. |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | Unknown | Unknown | No difference. Proposed and<br>predicate device are provided<br>nonsterile. |
| Specifications/<br>Features<br>Over-the-Counter<br>(OTC) | Yes | Yes | Yes | Yes | No difference |
| Power Source(s) | Rechargeable Lithium-ion<br>battery | Rechargeable Lithium-ion<br>battery | Rechargeable Lithium-ion<br>battery | 6.0 V D.C., 4 x AAA<br>batteries | Same battery type as Avail<br>and Quell<br>No difference |
| Method of Line<br>Current Isolation | N/A (internal power<br>source) | N/A (internal power source) | N/A (internal power source) | N/A (internal power source) | |
| Patient Leakage<br>Current | --- | --- | --- | --- | --- |

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| Feature | Proposed Device<br>PM710-M/PM710-L | Primary Predicate Device<br>Omron Avail Wireless Dual<br>Channel TENS PM601<br>K172079 | Reference Device<br>Quell<br>K152954 | Reference Device<br>Model R-T1 TENS<br>Stimulator<br>K180956 | Analysis of Technological<br>Differences |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------|
| -Normal Condition<br>(uA) | <10uA | <10uA | <10uA | 11.4uA | Same as Avail |
| -Single Fault<br>Condition (uA) | <50uA | <50uA | <100uA | 9.6uA | Same as Avail |
| Average DC current<br>through electrodes<br>when device is on<br>but no pulse are<br>being applied (uA) | 0 | 0 | <1uA | 0 | No difference |
| Number of output<br>Modes | 1 TENS mode | 9 TENS modes | 1 TENS mode | 18 TENS modes | Same as Quell |
| Number of output<br>channels | 1ch | 1ch | 1ch | Alternating 2 channels | Same as Avail and Quell |
| Synchronous or<br>Alternating | None | None | N/A | By electrical circuit and<br>software | Same as Avail |
| Method of Channel<br>Isolation | Regulated Current | Regulated Current | Regulated current | Regulated current | No difference |
| Regulated Current<br>or Regulated<br>Voltage | Microprocessor | Microprocessor | Yes | Yes | No difference |
| Software/Firmware/<br>Microprocessor<br>Control? | No | No | Yes | Yes | Same as Avail |
| Automatic Overload<br>Trip? | Yes | Yes | Yes | Yes | No difference |
| Automatic No-Load<br>Trip? | Yes | Yes | Yes | Yes | No difference |
| Automatic shut Off? | Yes, Power On/Off button<br>on the device | Yes, Power On/Off button on<br>the device and in the App<br>software | 4 button presses | Yes | Similar to Avail but with no<br>App associated with Focus<br>TENS |
| User over ride<br>control? | | | | | |

A5-10

{12}------------------------------------------------

| | 1<br>C<br>1 | 1 |
|----------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| | 1 | |
| | C | |
| € | WA TO WARDS OF THE | AAA V & AAA TVAV |
| | | |
| | ------------------------------------------------------------------------------------------------------------------------ | |
| | | And Annual Property of Children |
| | -<br>€ | |
| 1 | | |
| | | |
| | | |
| 1 | 1<br>€ | |
| Caroline | | 1 |
| | | |
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| | when a need cours nown some and submit | 1 |
| 1 | | |
| | 400 W | The Real Property of Children |
| | wa | |
| | WALL CALLERY | |
| 1 | | Call of Children |
| 1 | | 2 |
| | | 1 |
| | | |
| | C | Caroline of Children |

| Feature | Proposed Device<br>PM710-M/PM710-L | Primary Predicate Device<br>Omron Avail Wireless Dual<br>Channel TENS PM601<br>K172079 | Reference Device<br>Quell<br>K152954 | Reference Device<br>Model R-T1 TENS<br>Stimulator<br>K180956 | Analysis of Technological<br>Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|
| Indication display<br>On/Off Status? | Yes. LED indicator on<br>main unit | Yes on App and LED<br>indicator on main unit | Yes | Yes | Similar to Avail but with no<br>App associated with Focus<br>TENS |
| Low Battery? | Yes. LED indicator on<br>main unit | Yes on App | Yes | Yes | Similar to Avail but with no<br>App associated with Focus<br>TENS |
| Voltage/Current<br>Level? | Yes. LED indicator on<br>main unit | Yes on App | No | Yes | Similar to Avail but with no<br>App associated with Focus<br>TENS |
| Timer Range<br>(Minutes) | 30 minutes | 5-60minutes and<br>30-180minutes | 60 minutes | 30 minutes | Same as R-T1 and within<br>range of Avail |
| Compliance with<br>Voluntary<br>standards? | ES 60601-1, IEC60601-1-<br>2, IEC60601-2-10, IEC<br>60601-1-11 | ES 60601-1, IEC60601-1-2,<br>IEC60601-2-10, IEC 60601-<br>1-11 | IEC 60601-1, IEC 60601-1-<br>2, IEC 60601-1-6, IEC<br>62304, IEC 60601-1-11 | IEC 60601-1, IEC60601-1-2,<br>IEC60601-2-10, IEC 60601-<br>1-11…