PulseRelief

K151035 · Philips Consumer Lifestyle · NUH · Jul 21, 2015 · Neurology

Device Facts

• Record ID: K151035
• Device Name: PulseRelief
• Applicant: Philips Consumer Lifestyle
• Product Code: NUH · Neurology
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

PulseRelief is an OTC TENS/EMS stimulator for home use by adults. System components: control unit, battery unit, self-adhesive hydrogel electrodes, and mobile app. Input: user-selected treatment programs via mobile app (iOS/Android) using Bluetooth Low Energy. Operation: control unit generates electrical pulses (TENS for pain relief, EMS for muscle conditioning) delivered through skin-surface electrodes. Output: biphasic symmetrical electrical pulses; diary of treatment history stored on device. Healthcare provider role: none; patient self-operates. Clinical impact: temporary pain relief and muscle performance improvement via nerve/muscle stimulation. Benefits: non-invasive, portable, app-controlled pain management.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993), electrical safety (IEC 60601-1, 60601-1-11, 60601-2-10), EMC (IEC 60601-1-2), battery safety (IEC 62133), software verification/validation (IEC 62304), and usability testing (IEC 62366).

Technological Characteristics

Materials: PC ABS housing. Energy: 3.7V Li-ion battery. Output: 1 channel, biphasic symmetrical rectangular pulses, 1-100 Hz, 60-350 µs duration. Connectivity: Bluetooth Low Energy to mobile app. IP22 rated. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5/10. Software: Moderate level of concern, IEC 62304 compliant.

Indications for Use

Indicated for adult patients for temporary relief of pain in shoulder, waist, back, neck, arms, and legs due to exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate muscle performance. Contraindicated for use on non-healthy, wet, or unclean skin.

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

• OTC Electrical stimulator Models MT900I, LT3060 (K130802)

Reference Devices

• Philips Self-Adhesive Electrode (K151033)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with flowing lines representing the body and head.

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

July 21, 2015

Philips Consumer Lifestyle Marta Walker Senior Safety, Compliance & Regulatory Manager 1600 Summer Street Stamford, Connecticut 06905

Re: K151035

Trade/Device Name: Pulserelief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 1, 2015 Received: June 25, 2015

Dear Marta Walker:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (21 CFR 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,

# Michael J.Hoffmann -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K151035

Device Name PulseRelief

Indications for Use (Describe)

The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

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

| ☐ | Experimental Use (Specific to 21 CFR 58.3(d) - Laboratory Research) |
|---|-----------------------------------------------------------------------|
| ☑ | Clinical Trial (Specific to 21 CFR 58.3(c) - Clinical Investigations) |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

# 1. SUBMITTER OF 510(K):

| Company name:<br>Registration number:<br>Address: | Philips Consumer Lifestyle<br>3009181561<br>1600 Summer Street<br>Stamford, CT 06905 USA | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--|
| Phone:<br>email<br>Correspondent: | [phone]<br>[e-mail]<br>Marta Walker,<br>Sr. Manager Safety, Compliance & Regulatory | |
| Date of Preparation: | July 16th, 2015 | |

# 2. DEVICE:

| Trade/Proprietary Name: | PulseRelief |
|-------------------------|------------------------------------------------------------|
| Common/Usual Name: | TENS |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification Name: | Neurological Therapeutic Devices |
| Classification: | 21CFR 882.5890 and 890.5850 Class II |
| Product Code: | NUH and NGX |

The PulseRelief device is to be used with the Philips Self-Adhesive Electrode (K151033).

# 3. PREDICATE DEVICE

Our new device is based on the legally marketed device cited in the table below:

Table 1: Predicate device

| Manufacturer | Device | 510(k) # | Product Code: |
|--------------------------------------------------|-------------------------------------------------|----------|---------------|
| Shenzhen<br>Dongdixin<br>Technology<br>Co., Ltd. | OTC Electrical stimulator Models MT900I, LT3060 | K 130802 | NUH, NGX |

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# 4. DEVICE DESCRIPTION

PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities and can be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Pulse Relief is designed to be used at home, by adults of all genders

For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The device delivers pulses across the skin through these electrodes. This activates the underlying sensory nerves. The user can choose 15 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.

For Electrical Muscle Stimulation (EMS). the electrodes are placed near the muscle to be stimulated. The device generates electrical pulses and passes these pulses across the surface of the skin to activate the underlying motor nerves. This makes the muscle contract. Contraction helps to condition the muscle in in order to facilitate performance

The PulseRelief system consists of the following elements:

- Control unit with cable: generates the TENS/EMS pulses; connects to the 1st electrode; . communicates with the mobile device; connects to the battery unit. The control unit has an on-off button.
- . Battery unit: contains a battery and charging circuit; connects the 200 electrode to the control unit.
- . Electrodes: Self-adhesive re-usable hydrogel electrodes with metal target plate for magnetic clamping to the control unit and battery unit.
- . App on mobile device. The app controls the functions of the PulseRelief device via a Bluetooth Low Energy connection between the mobile device and the PulseRelief device.
- Adapter: for charging the battery unit via a micro-USB socket. To connect the USB-cable . to the battery unit, the control unit needs to be disconnected.

| | Parameter | PulseRelief Specification |
|-------------------------|---------------------------|-------------------------------------------|
| Treatment modes | TENS | 15 programs |
| | EMS | 5 programs |
| Pulse Output parameters | Number of output channels | 1 |
| | Current pulse shape | Biphase symmetrical<br>Image: pulse shape |
| | Frequency range | 1-100 Hz |
| | Pulse duration | 60-350 $\mu$ s |
| | Treatment duration | 1-59min or continuous |
| General specifications | Power supply | DC 3.7V Li-ion |
| | System IP Classification | IP22 |
| | Size | 53.5mm x 53.5mm x 11.5mm |
| | Weight | 62 grams |

Table 2: Main device parameters

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| | Parameter | PulseRelief Specification |
|------------------------------------|----------------------|--------------------------------------|
| Operating conditions | Temperature | 5°C to 40°C (41°F to 104°F) |
| Operating conditions | Relative humidity | 15%-93% (non-condensing) |
| Operating conditions | Atmospheric pressure | 700 to 1060 hPa |
| Storage conditions<br>(device) | Temperature | -10°C to 50°C (14°F to 122°F) |
| Storage conditions<br>(device) | Relative humidity | less than 93% (non-condensing) |
| Storage conditions<br>(device) | Atmospheric pressure | 700 to 1060 hPa |
| Storage conditions<br>(electrodes) | Temperature | 0°C to 40°C (32°F to 104°F) |
| Storage conditions<br>(electrodes) | Relative humidity | less than 93% (non-condensing) |
| Storage conditions<br>(electrodes) | Atmospheric pressure | 700 to 1060 hPa |
| Adapter | Rated input | 100-240V / 150mA |
| Adapter | Rated frequency | 50-60 Hz |
| Adapter | Rated output | 5V DC / 300mA |
| Electrode | Dimensions | 50mm x 50mm (2.16in x 2.16in) (2pcs) |

The PulseRelief device is controlled by means of an app on a mobile device (phone or tablet). The communication is done via Bluetooth Low Energy. The app operates on IOS and Android platforms (IOS 7 and 8, Android 4.4 KitKat and higher).

#### Interface with the user

With the app, the user can do the following:

- Select a body part (optional); by selecting a body part, a list of suggested treatments is . provided
- Enter a pain score (optional) .
- . Select a treatment
- . Select the treatment duration (optional)
- . Start, pause and stop a treatment
- . Increment and decrement the intensity
- . Enter a post-treatment sensation score
- . Display the Treatment Diary
- . Display the Instructions for Use
- . Display the battery status of the PulseRelief device
- Clear the Treatment Diary on a PulsRelief device .
- Decouple with a PulseRelief device ("forget my device") .

#### Diary function

The app contains a Diary function that shows the details of over 200 past treatments. For each treatment, the information consists of treatment data and time, treatment duration, treatment intensity, body part (if selected by user), pain score and satisfaction score (if scored by the user). The Diary data is stored on the PulseRelief device. The mobile device retrieves the actual Diary data from the connected PulseRelief.

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Interface with the PulseRelief device

The following functions are provided for communication between the PulseRelief device:

- Pair with a PulseRelief device .
- . Set or read the treatment program
- . Read the connection status of the electrodes
- Read the stimulation intensity .
- Set the treatment time ●
- . Read the remaining treatment time
- Increment the stimulation intensity ●
- . Decrement the stimulation intensity
- Set the stimulation intensity to zero .
- . Read the battery level of the PulseRelief device
- . Set or read the body part
- . Set or read the pain score
- . Set or read the Post-treatment sensation
- Read the Treatment Diary data, system data and event log data .
- Set the system time of the PulseRelief device .
- Read the system ID and unique device ID of the PulseRelief device .
- Read the firmware revision of the PulseRelief device .
- Factory reset of the PulseRelief device .

The controls and indicators of the PulseRelief device are listed in the Table below.

| Unit | Control/Indicator | User interface | Function |
|--------------|-------------------|--------------------------------------|--------------------------------------------------------------------|
| Control Unit | On-off button | Press button<br>(when device is off) | Device on, such that mobile<br>device can connect |
| | | Press button<br>(when device is on) | Device off (at any time, before,<br>during or after treatment) |
| | LED indicator | Off | Device is off |
| | | Green continuous | Device is on, no signal output is<br>active |
| | | Yellow blinking (1Hz) | Device is on, signal output is<br>active |
| | | Green rapid blinking (2Hz) | Device is on and in connection<br>mode, no signal output is active |
| Battery Unit | LED indicator | Off | Device is not connected to<br>charger |
| | | Red continuous | Device is connected to a<br>charger, battery is charging |
| | | Green continuous | Device is connected to a<br>charger, battery is fully charged |

Table 3: PulseRelief device controls and indicators

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# 5. INDICATION FOR USE:

## 5.1 PulseRelief

The OTC TENS/EMS stimulator PulseRelief is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

## 5.2 Predicate MT9001 OTC TENS/EMS stimulator

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

As demonstrated above, there are no differences in the intended use of the PulseRelief and the selected predicate, MT9001 OTC.

# 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

## 6.1 Basic Unit Characteristics

Both the PulseRelief and Predicate Device utilise the application of electrical current through electrodes placed on the skin for pain control, or electrical muscle stimulation (EMS) the elicitation of muscle contraction using electric impulses. The impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated.

A comparison of the basic characteristics of the PulseRelief and that of the Predicate is shown in the Table below.

| Parameter | PulseRelief | Predicate Device |
|-----------------------|-------------------------------|--------------------------------------------|
| 510(k) Number | (to be assigned) | K130802 |
| Device Name and Model | PulseRelief | MT9001 OTC<br>TENS/EMS stimulator |
| Manufacturer | Philips Consumer<br>Lifestyle | Shenzhen Dongdixin<br>Technology Co., Ltd. |
| Regulation Number | 882.5890<br>890.5850 | 882.5890<br>890.5850 |
| Product Code | NUH<br>NGX | NUH<br>NGX |
| Power Source(s)† | Li-ion 3.7V 500mAh | 9V battery |

Table 4: Substantial Equivalence Comparison Table

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| - Method of Line Current Isolation | N/A | N/A |
|--------------------------------------------------------|--------|--------|
| - Patient Leakage Current††<br>- Normal Condition (µA) | <10 µA | 0.61µA |

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| Parameter | | PulseRelief | Predicate Device |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| - Single Fault Condition (μA) | | <50 μA | 0.68μA |
| Average DC current through electrodes when<br>device is on but no pulses are being applied (µA) | | 0 | 0 |
| Number of Output Modes ††† | | 15 TENS<br>5 EMS | 2 (TENS/EMS) |
| Number of<br>Output<br>Channels††††: | Synchronous or Alternating? | N/A<br>(1 output channel) | Alternating |
| | Method of Channel Isolation | N/A<br>(1 output channel) | By electrical circuit and<br>software |
| | Regulated Current or Regulated Voltage? | Current control | Current control |
| | Software/Firmware/Microprocessor Control? | Yes | Yes |
| | Automatic Overload Trip? | Yes | Yes |
| | Automatic No-Load Trip? | Yes | Yes |
| | Automatic Shut Off? | Yes | Yes |
| User Override Control? | | Yes<br>power on/off button on<br>the device, and power<br>on/off in the App<br>software | Yes<br>Power on/off button on<br>the device |
| Indicator<br>Display: | On/Off Status? | Yes | Yes |
| | Low Battery? | Yes (on app) | Yes |
| | Voltage/Current Level? | Yes (on app) | Yes |
| Timer Range (minutes) | | 1~59 minutes<br>and continuous | 1~60 minutes |
| Compliance with Voluntary Standards? | | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10,<br>ISO10993-5/10 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10,<br>ISO10993-5/10 |
| Compliance with 21 CFR 898⁷? | | Yes | Yes |
| Weight (grams) | | 62g<br>(excl. electrodes) | 128g |
| Dimensions (mm) [W x H x D] | | 2 units,<br>each 54x54x14<br>(excl electrodes) | 117x60x34 |
| Housing Materials and Construction | | PC ABS | Plastic ABS |
| Parameter | PulseRelief | Predicate Device<br>K130802 | |
| Mode or Program Name | TENS mode | TENS mode | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | |
| Shape (e.g., rectangular, spike, rectified<br>sinusoidal) | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/- 20%) | 31 @500Ω<br>69 @ 2 kΩ<br>70 @ 10 kΩ | 48 @500Ω<br>100 @ 2 kΩ<br>105 @10 kΩ | |
| Maximum Output Current (specify units) (+/- 20%) | 62 @500Ω<br>34 @ 2 kΩ<br>7 @10 kΩ | 96 @500Ω<br>50 @ 2 kΩ<br>10.5 @10 kΩ | |
| Duration of primary (depolarizing) phase†<br>(msec) | 25 ~175 μs | 50μs ~ 300 μs | |
| Pulse Duration† (μsec) | 60 ~ 350 μs | 50μs ~ 300 μs | |
| Frequency† (Hz) [or Rate† (pps)] | 1 ~ 100 Hz | 1Hz ~ 150Hz | |
| For multiphasic<br>waveforms only: | Symmetrical phases? | Yes | Yes |
| Phase Duration† (include<br>units),(state range, if<br>applicable), (both phases, if<br>asymmetrical) | 25 ~ 175 μs | 50μs ~ 300 μs | |
| Net Charge (microcoulombs (mC) per pulse) (If<br>zero, state method of achieving zero net<br>charge.) | 0 μC @500Ω | 0 μC per pulse@500<br>ohm symmetric,<br>biphasic and leading<br>polarity alternates for<br>each successive,<br>Pulse + and pulse -<br>pulse channel. | |
| Maximum Phase Charge, (μC) | 1.6 ~ 6.8 @500Ω | 28.8 @500Ω | |
| Maximum Current Density,††(mA/cm2, r.m.s.) | 0.002 ~ 0.045<br>@500Ω | 1.15 @500Ω | |
| Maximum Average Current (average absolute<br>value), mA | 0.06 ~1.36 @500Ω | 4.32 @500Ω | |
| Maximum Average Power Density,††<br>(mW/cm2), (using smallest electrode<br>conductive surface area) | 0.24 ~ 1.69 @500Ω<br>(* see comment 1) | 0.373 @500Ω | |
| Burst Mode<br>(i.e., pulse trains): | (a) Pulses per burst | 5, 7 | 7 |
| | (b) Bursts per second | 1,2,3 | 0.5,1,2,3,4,5 |
| | (c) Burst duration (ms) | 62.5 ~ 87.5 | 70 |
| | (d) Duty Cycle: Line (b)<br>x Line (c) | 6.3% ~ 19% | 3.5 ~ 35% |
| ON Time (seconds) | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | |
| Additional Features (specify, if applicable) | N/A | N/A | |
| Parameter | PulseRelief | Predicate Device<br>K130802 | |
| Mode or Program Name | EMS mode | EMS mode | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | |
| Shape (e.g., rectangular, spike, rectified<br>sinusoidal) | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/- 20%) | 31 @500Ω<br>69 @ 2 kΩ<br>70 @10 kΩ | 48 @500Ω<br>114 @ 2 kΩ<br>115 @10 kΩ | |
| Maximum Output Current (specify units) (+/- 20%) | 62 @500Ω<br>34 @ 2 kΩ<br>7 @10 kΩ | 96 @500Ω<br>57 @ 2 kΩ<br>11.5 @10 kΩ | |
| Duration of primary (depolarizing) phase† (msec) | 75 ~175 µs | 50µs ~ 300 µs | |
| Pulse Duration† (µsec) | 150 ~ 350 µs | 50µs ~ 300 µs | |
| Frequency† (Hz) [or Rate† (pps)] | 40 ~ 65 Hz | 1Hz ~ 150Hz | |
| For multiphasic<br>waveforms only: | Symmetrical phases? | Yes | Yes |
| Phase Duration† (include<br>units),<br>(state range, if applicable),<br>(both phases, if<br>asymmetrical) | 75 ~ 175 µs | 50µs ~ 300 µs | |
| Net Charge (microcoulombs (mC) per pulse) (If<br>zero, state method of achieving zero net<br>charge.) | 0 µC @500Ω | 0 µC per pulse@500<br>ohm symmetric,<br>biphasic and leading<br>polarity alternates for<br>each successive,<br>Pulse + and pulse –<br>pulse channel. | |
| Maximum Phase Charge, (µC) | 4.7 ~ 10.9 @500Ω | 28.8 @500Ω | |
| Maximum Current Density,††(mA/cm², r.m.s.) | 0.019 ~ 0.037<br>@500Ω | 1.15 @500Ω | |
| Maximum Average Current (average absolute<br>value), mA | 0.47 ~ 0.93 @500Ω | 4.32 @500Ω | |
| Maximum Average Power Density,†† (W/cm²),<br>(using smallest electrode conductive surface<br>area) | 0.62~1.15 @500Ω<br>(* see comment 1 in<br>paragraph 6.2) | 0.373 @500Ω | |
| Burst Mode<br>(i.e., pulse trains): | (a) Pulses per burst | N/A | N/A |
| | (b) Bursts per second | N/A | N/A |
| | (c) Burst duration<br>(seconds) | N/A | N/A |
| | (d) Duty Cycle: Line (b)<br>x Line (c) | N/A | N/A |
| Parameter | PulseRelief | Predicate Device<br>K130802 | |
| ON Time (seconds)<br>- Intensity ramp-up<br>- Constant intensity<br>- Intensity ramp-down | 2 ~ 4 sec<br>5 ~ 6 sec<br>1 ~ 2 sec | 1 ~ 30 | |
| OFF Time (seconds) | 15 sec | 1 ~ 60 | |
| Additional Features (specify, if applicable) | N/A | N/A | |

Note! Table template from: 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

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# 6.2 Output Specifications TENS mode

Table 5: Output Specifications TENS mode

Additional comments relating to the differences between the PulseRelief and selected predicate:

- Comment 1 Maximum Average Power Density: The predicate device has a lower .

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value, but the maximum average power density is well below 250mW/cm2 as required by the FDA-guidance for TENS OTC. The safety and effectiveness of the device is not affected.

## 6.3 Output specifications EMS mode

Table 6: Output specifications EMS mode

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# 7. PERFORMANCE DATA

The following performance data are provided in support of the substantial equivalence determination:

# 7.1 Biocompatibility testing

The biocompatibility evaluation for the Brand X device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. As dictated by the application and duration of contact with the intact skin, the battery of testing included the following tests:

- · Cytotoxicity
- · Sensitization
- Irritation

## 7.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the PulseRelief. The system complies with the IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC, and IEC 62133 for battery safety.

For FCC part 15 RADIO FREQUENCY DEVICES, Subpart B-Unintentional Radiators, Subpart C-Intentional Radiators.

## 7.3 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

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## 7.4 Usability Testing

Usability testing according to IEC 62366 and following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted.

#### 7.5 Risk management

The risks to people, property and the environment associated with the use of the PulseRelief was managed according to ISO 14971:2007 Medical Devices- Application of risk management to medical devices (Second Edition)

#### 7.6 Symbols

The symbols used on the PulseRelief itself, on its packaging or in the associated documentation is conform ISO 15223-1:2012 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements (Second Edition)

# 8. CONCLUSION

The intended use and basic technological characteristics of the PulseRelief device are equivalent with those of the referenced Predicate device K130802. Any technological differences do not raise new questions regarding safety and effectiveness.

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