HIVOX SPOPAD EMS

K141921 · Hivox Biotek, Inc. · NGX · Jan 16, 2015 · Physical Medicine

Device Facts

• Record ID: K141921
• Device Name: HIVOX SPOPAD EMS
• Applicant: Hivox Biotek, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Device Story

HIVOX Spopad EMS (SP-910, SP-920, SP-620) are 1-channel, battery-operated powered muscle stimulators; designed for OTC self-use to exercise muscles. Device comprises electronic stimulator module generating stimulation signals; 2 or 4 electrodes connect signals to skin. Power supplied by CR2032 battery. User-friendly system; improves muscle tone, firmness, and strength; relaxes stiff muscles. Device operates via microprocessor control; delivers symmetrical biphasic rectangular waveforms. User applies device to target areas; output affects muscle contraction/relaxation cycles. Benefits include non-medication muscle training and self-training capability.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of comparative electrical output analysis, compliance with IEC 60601-1 (general safety), IEC 60601-2-10 (nerve/muscle stimulators), and IEC 60601-1-2 (EMC).

Technological Characteristics

Battery-powered (3V CR2032); silicone housing. Symmetrical biphasic rectangular waveform. 1-channel output. Microprocessor-controlled. Compliance: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Max current density <2 mA/cm²; max power density <0.0691-0.117 W/cm². Timer: 20 minutes.

Indications for Use

Indicated for healthy individuals seeking improvement of muscle tone, firmness, and strengthening in arms, abdomen, thighs, and buttocks. Not for use in therapy or treatment of medical conditions/diseases.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Body Control System (K092476)

Submission Summary (Full Text)

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

January 16, 2015

HIVOX BIOTEK, INC. Ke-Min Jen. Official Correspondent 5 F., No. 123 Shingde Road San-chong District New Taipei City. TW 24158

Re: K141921

Trade/Device Name: HIVOX Spopad EMS SP-910, SP-920, SP-620 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 7, 2014 Received: December 11, 2014

Dear Dr. Jen. Ke-Min:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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,

# Felipe Aquel -S

Carlos L. Peña, PhD, MS for 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) K141921

Device Name HIVOX Spopad EMS SP-910, SP-920, SP-620

#### Indications for Use (Describe)

These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

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

- Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the word "HIVOX" in a sans-serif font. The letters are black, and there is a registered trademark symbol after the "X". To the right of the word is a plus sign made up of four squares. The top left square is green, and the bottom right square is blue.

# 5. 510(k) SUMMARY (According to 21 CFR 807.92)

| ● | 510(K) OWNER'S<br>HIVOX BIOTEK INC. | |
|---|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAME | 5F, No.123, Shingde Road, Sanchong Dist.,<br>New Taipei City, 24158, TAIWAN, R.O.C. |
| | | TEL: [phone] FAX:[phone] |
| ● | Name Of Contact<br>Person | Dr. JEN, KE-MIN<br>TEL: [phone] FAX:[phone]<br>Email: [e-mail] |
| ● | Date Of Submission | July 5, 2014 |
| ● | Trade Name | HIVOX Spopad EMS SP-910, SP-920, SP-620 |
| ● | Common Name | Powered Muscle Stimulator |
| ● | Classification Name | Powered Muscle Stimulator<br>(21 CFR 890.5850, Product Code NGX) |
| ● | Panel | Physical Medicine |
| ● | Intended Use | These Electrical Muscle Stimulation units are indicated for the<br>improvement of muscle tone and firmness, for strengthening<br>muscles in arms, abdomen, thighs, and buttocks areas.<br>Not intended for use in any therapy or for the treatment of any<br>medical conditions or diseases. |
| ● | Device Design | EMS, Electrical Muscle Stimulation, which improves, tones,<br>firms & strengthens muscle and relaxes stiff muscle through the<br>skin. It is recognized as a clinically proven, effective,<br>non-medication method of training muscle from certain causes.<br>It manages muscle strengthen, toning and firming. It is also free<br>from side effects when used properly, and can also be used as a<br>simple means of self-training. |

HIVOX Spopad EMS SP series, SP-910 / SP-920 / SP-620 are the proposed subject devices for this 510(k) submission.

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Image /page/4/Picture/0 description: The image shows the word "HIVOX" in bold, black letters. To the right of the word is a plus sign made up of four squares. The top left and bottom right squares are green, and the top right and bottom left squares are blue.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.

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5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

| Comparison items | Predicate device 1<br>(PD) | Subject device<br>(1) | Subject device<br>(2) | Subject device<br>(3) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|
| Manufacturer<br>Submitter | SPORT-ELEC S.A. | HIVOX-BIOTEK | | |
| Device name | Body Control<br>System | Spopad EMS, SP series | | |
| Model number | 4M | SP-910 | SP-920 | SP-620 |
| 510(k) number | K092476 | TBA | TBA | TBA |
| Product code | NGX | | NGX | |
| Classification name | Powered Muscle<br>Stimulator | Powered Muscle Stimulator | | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | | |
| Indications for use | Indicated for the<br>improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms,<br>abdomen, thighs<br>and buttocks areas.<br>Contraindicated<br>use on injured or<br>otherwise impaired<br>muscles<br>Not intended for<br>use in any therapy<br>or for the treatment<br>of any medical<br>conditions or<br>diseases. | Indicated for the improvement of muscle tone<br>and firmness, for strengthening muscles in arms,<br>abdomen, thighs, and buttocks areas.<br>Not intended for use in any therapy or for the<br>treatment of any medical conditions or diseases. | | |
| Technology | Electrical Muscle<br>Stimulation | Electrical Muscle Stimulation | | |
| Power Source | 1.5V battery *3 | 3V Battery *1 | | |
| - Method of Line<br>Current Isolation | Battery supply | Battery Supply | | |
| - Patient Leakage<br>Current<br>Normal Condition (µA) | < 3 | | 2.0 | |
| Single Fault<br>Condition(µA) | < 4 | | 2.1 | |
| Method of channel<br>isolation | Software | 1 channel | | |

## Compare to Legally Marketed Predicate Devices _

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5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

| Average DC current<br>through electrodes when<br>device is on but no<br>pulses are being applied | 0 μΑ | 0 μΑ |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| Number of output<br>modes | 1 | 1 |
| Regulated current or<br>regulated voltage? | Voltage | Voltage |
| Software /firmware /<br>Microprocessor control? | Yes | Yes |
| Automatic overload<br>trip? | No | No |
| Automatic no-load trip? | No | No |
| Automatic shut-off? | Yes | Yes |
| User overrides control? | Yes | Yes |
| Indicator display -<br>On/Off Status | Yes | No |
| Indicator display – Low<br>battery? | Yes | No |
| Indicator display –<br>Voltage /Current | No | No |
| Timer Range (minutes) | N/A | 20 |
| Compliance with<br>voluntary standards? | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2<br>IEC 60601-1-4 | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60601-1-2 |
| Compliance with 21<br>CFR 898? | Yes | Yes |
| Housing material and<br>construction | ABS | Silicone |
| Output waveform | Monophasic | Symmetrical biphasic |
| Shape | Rectangular | Rectangular |
| Duration of primary<br>(depolarizing) phase | 0 | 0 |
| Pulse duration (μSec) | N/A | 400 |
| Maximum output<br>voltage (Voltage,<br>+/-10%) at 500 ohms | N/A | 52<br>58.4<br>60 |
| Maximum output<br>voltage (Voltage,<br>+/-10%) at 2k ohms | N/A | 102<br>106<br>109 |
| Maximum output<br>voltage (Voltage,<br>+/-10%) at 10k ohms | N/A | 150<br>146<br>140 |

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Image /page/7/Picture/0 description: The image shows the logo for HIVOX. The logo consists of the word "HIVOX" in black, sans-serif font. To the right of the word is a plus sign made up of four squares. The top left square is green, the top right square is white, the bottom left square is white, and the bottom right square is blue.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

| Maximum output<br>current (mA +/-10%) at<br>500 ohms | N/A | 104 | 117 | 120 | |
|---------------------------------------------------------|-------------------------|--------|--------|--------|----|
| Maximum output<br>current (mA +/-10%) at<br>2k ohms | N/A | 51 | 53 | 54.5 | |
| Maximum output<br>current (mA +/-10%) at<br>10k ohms | N/A | 15 | 14.6 | 14 | |
| Frequency (Hz) | N/A | 3/4/5 | 2/4/25 | 2/4/25 | |
| Net charge per pulse at<br>500 ohms (µC) | N/A | 0.416 | 0.468 | 0.960 | |
| Maximum charge at 500<br>ohms (µC) | N/A | 41.6 | 46.8 | 48 | |
| Maximum current<br>density at 500 ohms<br>(mA/cm²) | <2 | 1.328 | 1.057 | 1.952 | |
| Maximum average<br>power density at 500<br>ohms (W/cm²) | < 0.25 | 0.0691 | 0.0617 | 0.117 | |
| Burst mode | A. Pulse per burst | N/A | N/A | 25 | 25 |
| | B. Burst per second | N/A | N/A | 1 | 1 |
| | C. Burst duration (sec) | N/A | N/A | 20 | 20 |
| | D. Duty cycle | N/A | N/A | 20 | 20 |

#### Summary of comparison

Basically, the predicate device and Subject Devices are all Over-The-Counter muscle stimulators. Thus, the indications for use for the devices do not differ much.

PD and Subject Devices are all battery-powered, thus electric hazards or safety do not raise much concern, since maximum current / power densities for the devices are all less than 2 (mA/cm2) / 0.25 (W/cm2), which are the FDA recommended ratings. Since the electric output data for PD and Subject Devices only exist minor differences, the minor differences of the electric outputs do not raise any safety and effectiveness aspect. PD and Subject Devices all have the same safety and effectiveness, especially they all pass medical device electric safety standard, IEC 60601-1 and standard for Nerve and Muscle Stimulator, IEC 60601-2-10 and electromagnetic compatibility standard IEC 60601-1-2.

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Image /page/8/Picture/0 description: The image shows the logo for HIVOX. The logo consists of the word "HIVOX" in a bold, sans-serif font, followed by a registered trademark symbol. To the right of the wordmark is a stylized plus sign composed of four squares, two in green and two in blue. The overall design is clean and modern.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

We know that for effectiveness in achieving repeated muscle contractions, powered muscle stimulators typically are capable of stimulating muscle for at least one second per burst, and are capable of providing at least one second of muscle relaxation between successive pulse bursts. PD should meet these requirements. Subject Devices meet these requirements too. PD and Subject Devices are all validating-software processing, thus keeping regular processing parameters and safety functions normal. The Subject Devices have the same effectiveness as the predicate device.

In conclusion, the Subject Devices do not raise any new safety and effectiveness aspect with respect to the PD. Thus the Subject Devices are substantially equivalent to the predicate device.