HIVOX OTC Electrical Stimulator

K171803 · Hivox Biotek, Inc. · NUH · Nov 29, 2017 · Neurology

Device Facts

• Record ID: K171803
• Device Name: HIVOX OTC Electrical Stimulator
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: Nov 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HIVOX OTC Electrical Stimulator, SEM44 - 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), lower extremities (leg), abdomen and bottom 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. HIVOX OTC Electrical Stimulator, SEM44-1 - 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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

Device Story

HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) is a transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (EMS). Device uses adhesive electrodes applied to skin to deliver electrical impulses, mimicking body signals to stimulate nerve and muscle fibers. SEM44 provides both TENS and EMS; SEM44-1 provides TENS only. Features two independent channels; users select pre-set or custom programs. Operated by patients in home/OTC setting. Output provides tingling/vibrating sensation to influence nerve/muscle transmission. Benefits include temporary pain relief and improved muscle performance. Healthcare providers do not operate; output is used by patient to manage pain or muscle conditioning.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including shelf life, biocompatibility, software validation, electromagnetic compatibility, electrical safety, and functional performance testing.

Technological Characteristics

ABS housing; biphasic square waveform; 1-150Hz frequency; 4.5V battery power; two independent channels; software-controlled. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO 10993-5/10. Sterilization not specified.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, upper/lower extremities, abdomen, and bottom due to exercise or household work strain. EMS mode indicated for stimulation of healthy muscles to improve/facilitate muscle performance.

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 (MT9001, LT3060) (K130802)
• Tyece OTC TENS Device (SEM44) (K150386)

Submission Summary (Full Text)

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November 29, 2017

Hivox Biotek Inc. Linda Lin Territory Sales 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Tw

Re: K171803

Trade/Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 21, 2017 Received: August 31, 2017

Dear Linda Lin:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

William J. Heetderks -S 2017.11.29 20:14:45 -05'00'

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)

#### Device Name

HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)

Indications for Use (Describe)

HIVOX OTC Electrical Stimulator, SEM44 -

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), lower extremities (leg), abdomen and bottom 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.

HIVOX OTC Electrical Stimulator, SEM44-1 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

| Type of Use (Select <i>one or both</i> , as applicable) |
|---------------------------------------------------------|
|---------------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k), K171803/AIR Section 5 - 510(k) Summary

# 510(k) SUMMARY

| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|------------------------------------------------------------------------------------|
| 5.2 | Date of Summary: | November 29, 2017 |
| 5.3 | Submitter: | HIVOX BIOTEK INC. |
| | Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., New<br>Taipei City 24158, Taiwan, R.O.C. |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Mr. Linda Lin<br>([e-mail]) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | HIVOX OTC Electrical Stimulator |
|------------------------------|--------------------------------------------------------------------------------------------------|
| Model Number: | SEM44, SEM44-1 |
| Classification Product Code: | NUH |
| Subsequent Product Code: | NGX |
| Regulation Number: | 1) 882.5890<br>2) 890.5850 |
| Regulation Description: | 1) Transcutaneous electrical nerve<br>stimulator for pain relief<br>2) Powered muscle stimulator |
| Review Panel: | 1) Neurology<br>2) Physical Medicine |
| Device Class: | II |

#### 5.5 Identification of the Predicate Device:

| Predicate Device Name: | OTC Electrical stimulator |
|------------------------|-----------------------------------------|
| Model Number: | MT9001, LT3060 |
| Manufacturer: | Shenzhen Dongdixin Technology Co., Ltd. |

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| Classification Product Code: | NUH |
|------------------------------|-----------------------|
| Subsequent Product Code: | NGX |
| Regulation number: | 882.5890 |
| Device Class: | II |
| 510(k) Number: | K130802 |
| Predicate Device Name: | Tyece OTC TENS Device |
| Model Number: | SEM44 |
| Manufacturer: | SAVIA Ltd. |
| Classification Product Code: | NUH |
| Regulation number: | 882.5890 |
| Device Class: | II |
| 510(k) Number: | K150386 |

# 5.6 Intended Use/ Indications for Use of the Device

HIVOX OTC Electrical Stimulator, SEM44 -

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), lower extremities (leg), abdomen and bottom 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.

# HIVOX OTC Electrical Stimulator, SEM44-1 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

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# 5.7 Device Description

HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.

SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:

1. Electrical stimulation of nerve tracts (TENS)

2. Electrical stimulation of muscle tissue (EMS)

The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, SEM44 and SEM44-1 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities .; For EMS, SEM44 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For SEM44, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.

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# 5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, HIVOX OTC Electrical Stimulator (SEM44, SEM44-1).

- Shelf Life
- . Biocompatibility
- Software Validation
- Electromagnetic compatibility and electrical safety
- Function test

All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

# 5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

# 5.10 Substantial Equivalence Determination

The HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared OTC Electrical stimulator Models MT9001, LT3060 (K130802) and Tyece OTC TENS Device, Model SEM44 (K150386). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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| Item | Subject device | Predicate device I | Substantial equivalence determination |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | HIVOX OTC Electrical Stimulator | OTC Electrical stimulator | N/A |
| Model | SEM44<br>SEM44-1 | MT9001<br>LT3060 | |
| 510(k) No. | (to be assigned) | K130802 | |
| Intended Use | SEM44 –<br>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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.<br>EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. | MT9001 -<br>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.<br>EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.<br>LT3060 -<br>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 | Similar.<br>Both devices utilize TENS to release pain associated with sore and aching muscles, and EMS to improve and facilitate muscle performance. |

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| | | shoulder, waist, back, neck, upper extremities (arm), upper extremities (arm), lower extremities (leg) abdomen and bottom due to strain from exercise or normal household work activities. | and lower extremities (leg) due to strain from exercise or activities. normal household work activities. | | |
|----------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--|
| | Type of use | OTC | OTC | Same | |
| | | Basic Unit Characteristics | | | |
| Power Source | | 4.5V (batteries, 3x1.5V AAA) | 9V batteries | Different but does not adversely impact safety and effectiveness of subject device | |
| Method of Line Current Isolation | | N/A | N/A | Same | |
| Patient Leakage Current | Normal condition | N/A | 0.61μA | This parameter is not applicable to subject device. | |
| | Single fault condition | N/A | 0.68μA | | |
| Number of Output Modes | | TENS: 15<br>EMS: 35 | TENS: 1<br>EMS: 1 | Different but does not adversely impact safety and effectiveness of subject device | |
| Number of Output Channels | Synchronous or Alternating | 2 Synchronous | Alternating | Different but does not adversely impact safety and effectiveness of | |
| | | Method of<br>Channel<br>Isolation | | subject device | |
| | | By electrical circuit and<br>software | By electrical circuit and<br>software | Same | |
| | Regulated Current or<br>Regulated Voltage? | Regulated voltage | Current control | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| | Software/Firmware/<br>Microprocessor Control? | Yes | Yes | Same | |
| | Automatic Overload Trip? | Yes | Yes | Same | |
| | Automatic No-Load Trip? | Yes | Yes | Same | |
| Automatic Shut Off? | | Yes | Yes | Same | |
| User Override Control? | | Yes | Yes | Same | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | Same | |
| | Low Battery | Yes | Yes | Same | |
| | Voltage/<br>Current<br>Level | Yes | Yes | Same | |
| Timer Range (minutes) | | 5-100 minutes | 1-60 minutes | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Compliance with Voluntary<br>Standards | | IEC 60601-1,<br>IEC 60601-1-2. | IEC 60601-1,<br>IEC 60601-1-2. | Same | |

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| | IEC 60601-2-10,<br>ISO10993-5/10 | IEC 60601-2-10,<br>ISO10993-5/10 | | | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Compliance with 21 CFR<br>898-7 | Yes | Yes | Same | | |
| Weight | 89 g (including belt clip,<br>without batteries),<br>123 g (including belt clip<br>and batteries) | 128g (including batteries) | Slightly different<br>but does not<br>impact safety and<br>effectiveness of<br>subject device | | |
| Dimensions [L x W x T] | 132 x 63 x 29.5 mm<br>(including belt clip) | 117 x 60 x 34 mm | Slightly different<br>but does not<br>impact safety and<br>effectiveness of<br>subject device | | |
| Housing Materials and<br>Construction | ABS | ABS | Same | | |
| Output Specifications | | | | | |
| Waveform (e.g., pulsed<br>monophasic, biphasic) | Biphasic | Biphasic | Same | | |
| Shape (e.g., rectangular,<br>spike, rectified sinusoidal) | Square | Square | Same | | |
| Maximum<br>Output Voltage<br>(Volts, Vpp) | @500Ω | 100±10% | 96±20%<br>(48±20% (Vp)) | Different but | |
| | @2KΩ | 180±10% | 200±20%<br>(100±20%<br>(Vp))<br>228±20%<br>(114±20%<br>(Vp)) | does not<br>adversely impact<br>safety and | |
| | @10KΩ | 250±10% | 210±20%<br>(105±20%<br>(Vp))<br>230±20%<br>(115±20%<br>(Vp)) | effectiveness of<br>subject device | |
| Maximum | @500Ω | 200±10% | 96±20% | Different but | |
| | | | | | |
| Output<br>Current (mA) | @2KΩ | 90±10% | 50±20% | 57±20% | does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | @10KΩ | 25±10% | 10.5±20% | 11.5±20% | |
| Duration of primary phase | | 50-450μS | | 50-300μS | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Pulse Duration | | 50-450μS | | 50-300μS | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Frequency | | 1-150Hz | 1-150Hz | | Same |
| For interferential modes<br>only – Beat Frequency | | N/A | N/A | | Same |
| For<br>multi-program<br>waveforms<br>only – | Symmetrical<br>Phases? | N/A | Yes | | This parameter is<br>not applicable to<br>subject device. |
| | Phase<br>Duration | N/A | 50-300μS | | |
| Net charge (micro coulombs<br>µC) (per pulse) | | 0.001μC@500Ω | 0μC@500Ω | | Same |
| method of achieving zero<br>net charge | | N/A | biphasic and leading<br>polarity alternates for each<br>successive, Pulse + and<br>pulse – pulse channel | | This parameter is<br>not applicable to<br>subject device. |
| Max. phase charge (mC) | | 0.045@500Ω | 0.0288@500Ω | | Different but<br>does not |
| | | | | | adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | | | | | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Max. current Density<br>(mA/cm², r.m.s) | | 0.667@500Ω | | 1.15@500Ω | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Max. Average current<br>(average absolute value),<br>mA | | 13.5@500Ω | | 4.32@500Ω | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Max. Average Power<br>Density, W/cm² (using<br>smallest electrode<br>conductive surface area) | | 0.0046@500Ω | | 0.373@500Ω | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Burst<br>Mode<br>(i.e.<br>pulse<br>trains) | (a) Pulses per burst | 3 | 7 | N/A | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | (b) Bursts per<br>second | 2/60Hz | 0.5/1/2/3/4/5<br>Hz | N/A | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | (c) Burst duration | 36ms | 70ms | N/A | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | (d) Duty cycle | 36ms/390ms | 35ms/350ms | N/A | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| ON Time (seconds) | | 2 | N/A | 1-30 | Similar and does<br>not impact safety<br>and effectiveness<br>of subject device |
| OFF Time (seconds) | 2 | N/A | 1-60 | Similar and does<br>not impact safety<br>and effectiveness<br>of subject device | |
| Electrode area | 20.25sqcm x4 (81sqcm) | 25sqcm x2 (100sqcm) | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | | |
| Average DC current through<br>electrodes when device is on<br>but no pulses are being<br>applied (µA) | 0 | 0 | Same | | |

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| Item | Subject device | Predicate device II | Substantial<br>equivalence<br>determination |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Proprietary Name | HIVOX OTC Electrical<br>Stimulator | Tyece OTC TENS Device | N/A |
| Model | SEM44-1 | SEM44 | N/A |
| 510(k) No. | (to be assigned) | K150386 | N/A |
| Intended Use | 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), lower extremities (leg), abdomen and bottom due to strain from exercise or | The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities. | Similar.<br>Both devices utilize TENS to release pain associated with sore and aching muscles. |

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| | | household<br>normal<br>work | | | | | |
|-----------------------------------------------|-------------------------------------|---------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------|--|--|--|
| | | activities. | | | | | |
| Type of use | | OTC | OTC | Same | | | |
| | Basic Unit Characteristics | | | | | | |
| Power Source | | 4.5V (batteries, 3x1.5V | 4.5V (batteries, 3x1.5V | Same | | | |
| | | AAA) | AAA) | | | | |
| | Method of Line Current<br>Isolation | N/A | N/A | Same | | | |
| Patient | Normal condition | N/A | N/A | Same | | | |
| Leakage<br>Current | Single fault<br>condition | N/A | N/A | | | | |
| Number of Output Modes | | TENS: 15 | 15 Modes (01-15) | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | | | |
| | Synchronous<br>Or<br>Alternating | 2 Synchronous | 2 Synchronous | Same | | | |
| Number of<br>Output<br>Channels | Method of<br>Channel<br>Isolation | By electrical circuit and<br>software | PCB Insulation<br>Boost Isolation | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | | | |
| Regulated Current or<br>Regulated Voltage? | | Regulated voltage | Regulated voltage | Same | | | |
| Software/Firmware/<br>Microprocessor Control? | | Yes | Yes | Same | | | |
| Automatic Overload Trip? | | Yes | No | Different but | | | |

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| | | | | does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Automatic No-Load Trip? | | Yes | Yes | Same |
| Automatic Shut Off? | | Yes | Yes | Same |
| User Override Control? | | Yes | Yes | Same |
| | On/Off<br>Status | Yes | Yes | Same |
| | Low Battery | Yes | Yes | Same |
| Indicator<br>Display | Voltage/<br>Current<br>Level | Yes | Yes for voltage | Similar and does<br>not impact safety<br>and effectiveness<br>of subject device |
| Timer Range (minutes) | | 5-100 minutes | 5-100 minutes | Same |
| Compliance with Voluntary<br>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 | Same |
| Compliance with 21 CFR<br>898-7 | | Yes | Yes | Same |
| Weight | | 89 g (including belt clip,<br>without batteries),<br>123 g (including belt clip<br>and batteries) | 101 g (including belt chip) | Slightly different<br>but does not<br>impact safety and<br>effectiveness of<br>subject device |
| Dimensions [W x H x D] | | 132 x 63 x 29.5 mm<br>(including belt clip) | 132 x 63 x 29.5 mm<br>(including belt clip) | Same |
| Housing Materials and<br>Construction | | ABS | ABS | Same |
| Output Specifications | | | | |
| Waveform (e.g., pulsed<br>monophasic, biphasic) | | Biphasic | Biphasic | Same |
| Shape (e.g., rectangular,<br>spike, rectified sinusoidal) | | Square | Square | Same |
| Maximum<br>Output Voltage<br>(Volts, Vpp) | @500Ω | 100±10% | 70±15% | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | @2KΩ | 180±10% | 110±15% | |
| | @10KΩ | 250±10% | 190±15% | |
| Maximum<br>Output Current<br>(mA) | @500Ω | 200±10% | 86±15% | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| | @2KΩ | 90±10% | 23.3±15% | |
| | @10KΩ | 25±10% | 3.75±15% | |
| Duration of primary phase | | 50-450μS | 0 | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Pulse Duration | | 50-450μS | 50-360μS | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Frequency | | 1-150Hz | 1-150Hz | Same |
| For<br>multi-program | Symmetrical<br>Phases? | N/A | N/A | Same |
| waveforms<br>only | Phase<br>Duration | | | |
| Net charge (micro coulombs<br>μC) (per pulse) | $0.001μC@500Ω$ | $0.001μC @500Ω$ | Same | |
| Max. phase charge (mC) | $0.045@500Ω$ | $0.0454@500Ω$ | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Max. current Density<br>(mA/cm², r.m.s) | $0.667@500Ω$ | $0.790@500Ω$ | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Max. Average current<br>(average absolute value),<br>mA | $13.5@500Ω$ | $16.0@500Ω$ | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Max. Average Power<br>Density, W/cm² (using<br>smallest electrode<br>conductive surface area) | $0.0046@500Ω$ | $0.00632@500Ω$ | Different but<br>does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Burst<br>Mode<br>(i.e.<br>pulse | (a) Pulses per burst | 3 | 4 | Different but<br>does not<br>adversely impact<br>safety and |
| | (b) Bursts per<br>second | 2/60Hz | 4/83Hz | adversely impact<br>safety and |
| | (c) Burst duration | 36ms | 0.18ms | safety and |
| trains) | (d) Duty cycle | 36ms/390ms | 35ms/60ms | effectiveness of<br>subject device |
| | ON Time (seconds) | 2 | 2 | Same |
| | OFF Time (seconds) | 2 | 2 | Same |
|…