Hi-Dow Wireless TENS/EMS System (Model HD-5N)

K163393 · Hi-Dow International, Inc. · NUH · Aug 4, 2017 · Neurology

Device Facts

• Record ID: K163393
• Device Name: Hi-Dow Wireless TENS/EMS System (Model HD-5N)
• Applicant: Hi-Dow International, Inc.
• Product Code: NUH · Neurology
• Decision Date: Aug 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Battery-operated wireless pulse generator; consists of remote control unit and wireless receivers attached to electrodes. Remote sends 2.4GHz RF signals to receivers to control intensity and mode. Receivers generate electrical impulses delivered transdermally via adhesive hydrogel electrodes. Used in home environment by patient. TENS mode stimulates nerves to reduce pain sensation; EMS mode produces muscle contractions for conditioning. Output adjustable (20 intensity levels, 45-minute timer). Benefits include non-invasive pain relief and muscle performance improvement.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), FCC Part 15 compliance for RF emissions, and biocompatibility testing (ISO 10993-1, 5, 10).

Technological Characteristics

Wireless pulse generator; ABS housing; 3.7V Lithium battery. RF 2.4GHz communication. Pulsed biphasic waveform; regulated voltage. 2 channels; 4 modes. Type BF applied part. Biocompatible hydrogel electrodes. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, ISO 10993. Software-controlled.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, neck, upper extremities, and lower extremities due to exercise or household strain (TENS); and for stimulation of healthy muscles to improve/facilitate performance (EMS). Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic/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

• Hi-Dow Model JQ-5C Powered Muscle Stimulator (K102598)
• FDES106(ED406) Mini TENS&EMS Device (K130723)

Reference Devices

• WiTouch™ Pro (K120398)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design underneath them.

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

August 4, 2017

Hi-Dow International, Inc. % Schevon Salmon Associate Attorney Benjamin L. England & Associates, LLC 810 Landmark Drive, Suite 126 Glen Burnie, Maryland 21061

Re: K163393

Trade/Device Name: Hi-Dow Wireless TENS/EMS (Model HD-5N) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: July 11, 2017 Received: July 13, 2017

Dear Schevon Salmon:

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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,

# 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) K163393

Device Name

Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Indications for Use (Describe) TENS:

To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS:

It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) |
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date of Summary Preparation: 8/4/2017

#### 1. Submitter

Hi-Dow International, Inc. 2555 Metro Blvd Maryland Heights, MO 63043 Tel: [phone] Fax: [phone] E-mail: [e-mail] Contact: Mr. Eric Chen

### 2. Name of the Device

| Proprietary Name: | Hi-Dow Wireless TENS/EMS System, Model HD-5N |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | 1. Transcutaneous Electrical Nerve Stimulator for pain relief: TENS<br>2. Powered Muscle Stimulator |
| Classification: | 1. Stimulator, Nerve, Transcutaneous, Over-The-Counter<br>2. Stimulator, Muscle, Powered, Over-the-Counter |
| Classification Regulation: | 1. 21 CFR 882.5890<br>2. 21 CFR 890.5850 |
| Product Code: | 1. NUH<br>2. NGX |
| Classification Panel: | 1. Neurology<br>2. Physical Medicine |
| Device Classification: | Class 2 |
| Contraindications: | Do not use this device if you have a cardiac pacemaker, implanted<br>defibrillator, or other implanted metallic or electronic device. Such<br>use could cause electric shock, burns, electrical interference, or<br>death. |

#### 3. The Predicate Device

K102598, Hi-Dow Model JQ-5C Powered Muscle Stimulator (21 CFR 890.5850)

Transcutaneous Electrical Nerve Stimulator for pain relief (21 CFR 882.5890) This predicate has not been subject to a design-related recall.

#### 4. Secondary Predicate

K130723, FDES106(ED406) Mini TENS&EMS Device Powered Muscle Stimulator (21 CFR 890.5850) Transcutaneous Electrical Nerve stimulator for pain relief (21 CFR 82.5890)

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#### 5. Reference Device

K120398, WiTouch™ Pro, (Transcutaneous electrical nerve stimulator for pain relief) 21CFR 882.5890. This device is included to provide an example of a cleared radiofrequency controlled device in the TENS/PMS regulatory classification; it is not included for its specific intended use or product code. The Subject Device has very similar technological specifications and is in the same regulatory category.

#### 6. Device Description

The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles.

The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains.

The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes.

The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device.

The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit.

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.

#### 7. Intended Use of Device

#### TENS

The Hi-Dow Wireless TENS/EMS System. Model HD-5N is intended to be used for temporary relief of pain associated with sore or 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

Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

#### 8. Summary of Substantial Equivalence

The Hi-Dow Wireless TENS/EMS System, Model HD-5N and HI-Dow, Model JQ-5C (K102598) devices are very similar. They deliver essentially the same electrical energy transdermally using electrodes and gel. They differ in how the control unit interacts with the

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#### 7. 510(k) Summ

electrodes. In Model JQ-5C, the control and the power delivery functions are housed in the same unit. Electrodes, attached to the patient, are connected directly to the control/power unit. The wireless device (Model HD-5N) separates the control aspect from the electrical power delivery unit. The Hi-Dow Wireless TENS/EMS system separates the control aspects from the electrical power delvery unit. The control unit sends radiofrequency signals to the receiving power delivery unit which generates impulses according to the corresponding mode of operation and level of treatment.

The technological characteristics of the Hi-Dow Wireless TENS/EMS System and secondary predicate, FDES106(ED406) Mini TENS&EMS Device, are very similar. They both deliver electrical energy transdermally using electrodes. They differ in how the control unit interacts with the electrodes and the performance data. In FDES106(ED406), the control and power delivery are housed in the same unit and electrodes are connected directed to the control/power unit. The devices also use AA batteries.

Table: The table below provides analysis of the similarities and difference between HD-5N, the predicate ((K102598 JQ-5C) and the secondary predicate device (K130723).

#### 9. Comparison of Technological Characteristics with the Predicate Devices

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# 14. Substantial Equivalence Discussion

| | | | Secondary Predicate |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Elements of Comparison | Subject device | Predicate Device | Device |
| 510(k) Number | K163393 | K102598 | K130723 |
| Device Name and<br>Model | Powered Muscle Stimulator and<br>Transcutaneous electrical nerve stimulator<br>for pain relief HD-5N | JQ-5C | FDES106(ED406) Mini<br>TENS&EMS Device |
| Manufacturer | Hi-Dow Electron Technology(Hefei)<br>Inc., Ltd. | Hefei Jianqiao Sci-tech Development<br>Co., Ltd. | Famidoc Technology Co., Ltd |
| Intended Use & Indications for Use | TENS<br>To be used for the temporary relief of<br>pain associated with sore or aching<br>muscles in the shoulder, waist, back,<br>upper extremities (arm), and lower<br>extremities (leg) due to strain from<br>exercise or normal household work<br>activities.<br>EMS:<br>Intended to be used to stimulate healthy<br>muscles in order to improve and<br>facilitate muscle performance. | To be used for the temporary relief of pain<br>associated with sore and aching muscles in the<br>shoulder, waist, back, neck, upper extremities<br>(arm), and lower extremities (leg) due to strain<br>from exercise or normal household work<br>activities.<br>It is intended to be used to stimulate healthy<br>muscles in order to improve and facilitate<br>muscle performance. | For program N, B and H of TENS<br>mode<br>To be used for temporary relief of pain<br>associated with sore and aching<br>muscles due to strain from exercise or<br>normal household work activities.<br>For program El and E2 of EMS mode<br>Used to stimulate healthy muscles in<br>order to improve and facilitate<br>muscle performance. |
| Basic Unit Characteristics | | | |
| Device Power Source(s) | DC 3.7V Lithium Battery | DC 3.7 V Lithium Battery | Battery powered, d.c. 3.0V, 2 X AAA<br>batteries |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part |

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| Patient Leakage Current | | NC | DC:<10μA AC:<100 μA | DC:<10μA AC: < 100 μA | 0.9μΑ |
|----------------------------------------------|---------------------------|-----|-------------------------------------------------------------------|---------------------------------|------------------------------------|
| | | SFC | DC:<50μA AC:<500 μA | DC:<50μA AC: < 500 μA | 0.8μA |
| Number of Output Channels | | | 2 | 2 | 1 |
| Number of Output Modes | | | 4 | 6 | 5 |
| Synchronous or Alternating? | | | 2 Channel Asynchronous | 2 Channel Synchronous | Alternating |
| Method of Channel Isolation | | | Two separate devices, and use<br>independent power supply system. | Parallel | By Electrical Circuit and Software |
| Regulated Current or Regulated<br>Voltage? | | | Regulated Voltage | Regulated Voltage | Regulated Voltage |
| Software/Firmware/Microprocessor<br>Control? | | | Yes | Yes | Yes |
| Automatic Overload Trip? | | | No | No | Yes |
| Automatic No-Load Trip? | | | No | No | Yes |
| Automatic Shut Off | | | Yes | Yes | Yes |
| User Override Control ? | | | Yes | Yes | Yes |
| | On/Off Status? | | Yes | Yes | Yes |
| Indicator | Low Battery? | | Yes | Yes | Yes |
| Display | Voltage/Current<br>Level? | | No | No | No |
| Timer Range | | | 45mins | 10 ~ 60mins | 30 mins |
| Compliance with 21 CFR 898? | | | Yes | Yes | Yes |
| Weight (lbs., oz.) | | | Remote: 2.2 oz. | 1.5 oz. | .093 oz. |
| | | | Receiver: 0.85oz. | | |
| Dimensions (in.) [W x H x D] | | | Remote: 4.25"(W) x 2.1" (H) x 0.6" (D) | 3.15"(W) x 1.65" (H) x 0.55"(D) | 2.5"x1.77"x0.36" |
| | | | Receiver:Φ2.25" (Diameter) x 0.47"(D) | | |

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| Electrode shape(square, round,<br>rectangular, oval) and<br>size(L*W(cm)or area cm²) | | Oval electrode pad(gel),<br>4.5*3cm, 12cm²;<br>Rectangular electrode pad(gel),<br>9*4cm, 36cm²;<br>Rectangular electrode pad(gel),<br>9*6cm, 54cm²; | Oval electrode pad(gel), 9cm²; | N/A |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Housing Material and Construction | | ABS | ABS and metal | Plastic (ABS)<br>Enclosure |
| Output Specifications | | | | |
| Waveform (e.g., pulsed monophasic,<br>biphasic) | | Pulsed Biphasic | Pulsed Biphasic | Pulsed Biphasic |
| Shape (e.g., rectangular, spike,<br>rectified sinusoidal) | | Rectangular | Rectangular | Square |
| For<br>multiphasic | Symmetrical<br>phases? | YES | YES | Yes |
| waveforms<br>only: | Step-i and Step-3<br>Phase Duration<br>(include units),<br>(state range, if<br>applicable),<br>(both phases, if<br>asymmetrical) | TENS & EMS : 100µS | 100µS | - |
| | Step-2 Phase<br>Duration (include<br>units), (state range,<br>if applicable), (both<br>phases, if<br>asymmetrical) | TENS & EMS : 100µS | 100µS | - |
| Frequency (Hz) | | (TENS) MODE 3: 1.28<br>(TENS) MODE 4: 1~59.8<br>(EMS) MODE 1: 52.3<br>(EMS) MODE 2: 5.8 | 1~68 | TENS: 2 ~ 80<br>EMS: 2 ~ 50 |
| phase Duration(include units) (S) | | (TENS) MODE 3: Continuous<br>(TENS) MODE 4: 92.5<br>(EMS) MODE 1: 4.6<br>(EMS) MODE 2: 4.8 | Continuous / 4.5~93 | TENS: 200 ~ 350µS<br>EMS: 250µS |
| Maximum output<br>Voltage ,(Vpeak, specify units v) | | (TENS) MODE 3: 48.5V@500Ω<br>(TENS) MODE 4: 41.1V@500Ω<br>(EMS) MODE 1: 37.9V@500Ω<br>(EMS) MODE 2: 46.8V @500Ω | 62.4V@500Ω | TENS: 30.4V@500Ω<br>EMS: 28V@500Ω |
| Maximum output Current, (Ipeak,<br>specify units mA) | | (TENS) MODE 3: 97mA@500Ω<br>(TENS) MODE 4: 82.2mA@500Ω<br>(EMS) MODE 1: 75.8mA@500Ω<br>(EMS) MODE 2: 93.6mA@500Ω | 124.8mA@500Ω | TENS: 60.8mA@500Ω<br>EMS: 56mA@500Ω |
| Net Charge, (µC per pulse) | | (TENS) MODE 3: 9.7µC@500Ω<br>(TENS) MODE 4: 8.22µC@500Ω<br>(EMS) MODE 1: 7.5µC@500Ω<br>(EMS) MODE 2: 9.36µC@500Ω | 0µC@500Ω | TENS: 15.2µC@500Ω<br>EMS: 14µC@500Ω |
| | Maximum phase Charge, (µC) | (TENS) MODE 3: 38.8µC@500Ω<br>(TENS) MODE 4: 32.88µC@500Ω<br>(EMS) MODE 1: 15µC@500Ω<br>(EMS) MODE 2: 37.44µC@500Ω | 49.92µC@500Ω | TENS:15.2µC@500Ω<br>EMS: 14µC@500Ω |
| Maximum<br>Current<br>Density,<br>(mA/cm²) | | (TENS) MODE 3: 8.08mA/cm²@500Ω<br>(TENS) MODE 4: 6.85mA/cm²@500Ω<br>(EMS) MODE 1: 6.31mA/cm²@500Ω<br>(EMS) MODE 2: 7.8mA/cm²@500Ω | 13.86mA@500Ω | TENS: 4.1mA/cm²@500Ω<br>EMS: 3.77mA/cm²@500Ω |
| Maximum Average Current( mA). | | (TENS) MODE 3: 0.0124mA@500Ω<br>(TENS) MODE 4: 0.492mA@500Ω<br>(EMS) MODE 1: 0.393mA@500Ω<br>(EMS) MODE 2: 0.054mA@500Ω | 0.761mA@500Ω | TENS: 0.51mA@500Ω<br>EMS: 0.41mA@500Ω |
| (mW/CM²), | Maximum Average Power Density<br>(using<br>smallest<br>electrode conductive surface area) | (TENS) MODE 3: 0.05W/cm²@ 500Ω<br>(TENS) MODE 4: 1.68W/cm²@ 500Ω<br>(EMS) MODE 1: 1.25W/cm²@ 500Ω<br>(EMS) MODE 2: 0.21W/cm²@ 500Ω | 5.27 mW/cm2@ 500Ω | TENS: 2mW/cm²@500Ω<br>EMS: 1.2mW/CM²@500Ω |
| Burst | Pulses per burst | Continuous / complex; 41~181 | Continuous / 38.5~510 | TENS: 7 |
| | Bursts per second | Complex / 0.208~0.217 | 0.086~0.78 | TENS: 2 |
| Mode(i.e.,<br>pulse trains) | Burst<br>duration(seconds) | Continuous / 4.6~92.5 | Continuous / 4.5~93 | TENS: .02 |
| | ON Time(seconds) | 0.1 | 0.1 | - |
| | OFF Time(seconds) | 0.1 | 0.1 | - |
| Remote communication mode? | | RF: 2.4GHz transceiver | N/A | N/A |
| | Wireless | FCC Part 15 Conducted Emissions | N/A | N/A |
| | | FCC Part 15 Radiated Emissions | | |
| | | Remote Control:<br>FCC ID:2ACD4HD-5N-TX<br>Device: FCC ID:2ACD4HD-5N-RX | | |
| Additional Features | | | | |
| Environment for operating | | Temperature : 5°C to 40°C(41°F~104°F)<br>Humidity(non-condensing) : 30%-75%,<br>Atmospheric pressure : 700 to 1060Hpa | Temperature: 10°C~40°C (50°F~104°F)<br>Humidity(non-condensing) : ≤80%<br>Atmospheric pressure: 800~1050Hpa | Temperature : 5°C to 40°C(41°F~104°F)<br>Humidity(non-condensing) : 30%-85%, |
| Environment for storage | | Temperature: -10°Cto55°C (14°F~131°F)<br>Humidity(non-condensing) : 10%-90%<br>Atmospheric pressure : 700 to 1060Hpa | Temperature: -20°C~60°C (-4°F~140°F)<br>Humidity(non-condensing) : 10~95% | Temperature: -10°Cto50°C (14°F~122°F)<br>Humidity(non-condensing) : 10%-90% (non-<br>condensing) |
| Standards | | | | |
| Biocompatibility | | All user directly contacting materials are<br>compliance with | EN ISO 10993-1:2009 | Compliant with requirements of ISO 10993-5<br>and ISO 10993-10 standards |
| | | ISO10993-1:2009/C1: 2010,<br>ISO10993-5:2009,<br>ISO10993-10:2010. | | |
| | Electrical Safety | IEC 60601-1:2005 (Third Edition) + Corr.<br>1:2006 + Corr. 2:2007 + A1:2012 (or IEC<br>60601-1:2012 reprint); IEC 60601-2-<br>10:2012; also complies with<br>ANSI/AAMI ES60601-1:2005 + A1:2012,<br>C1: 2009 and A2: 2010 EN 60601-1: 2006<br>EN 60601-2-10: 2000 + A1: 2001 | EN 60601-1: 2006<br>EN 60601-2-10: 2000 + A1: 2001 | Compliant with requirements<br>IEC 60601-1,<br>IEC 60601-2-10, IEC 60601-1-1-2 |
| | EMC | IEC 60601-1-2:2007, IEC 60601-1-<br>11:2010 Clause 12, IEC 60601-2-<br>10:2012 Clause 201.17&202; | EN60601-1, EN60601-1-2, EN ISO<br>14971:2009, EN 60601-2-10:2000 +<br>A1:2001 | Compliant with requirements IEC 60601-1-2,<br>IEC 60601-2-10. |

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#### 10. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility testing

The biocompatibility evaluation for the electrodes and the gel used with these devices 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. The battery of testing included the flowing tests:

ISO10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process

ISO10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity

ISO10993-10:2010, Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization

#### Electrical safety and electromagnetic compatibility (EMC) and Other Standards

The following tests were performed on the Hi-Dow Wireless TENS/EMS System, Model HD-5N device in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance. Also complies with ANSI/AAMI ES60601-1:2005 + A1:2012, C1: 2009 and A2: 2010, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.

IEC60601-1-2:2007,EN60601-1-2:2007,Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.

IEC60601-2-10:2012/EN60601-2-10:2015 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulator IEC 60601-1-11: 2010/EN 60601-1-11: 2010; Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

FCC Part 15 "Conducted Emissions"

FCC Part 15 "Radiated Emissions"

#### Software Verification and validation Testing

Software verification and validation testing were conducted and documents were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in injury to

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the patient or operator.

#### 11. Conclusion

Based on the electrical characteristics tested under IEC 60601, the Hi-Dow Wireless Device performs the same as the cleared devices, the Hi-Dow Model JQ-5C and FDES106(ED406) Mini TENS&EMS Device. This supports the conclusion that it is as safe and as effective as the cleared devices for the stated indications.

---END OF 510(K) SUMMARY---