HIVOX Spopad EMS SP-911, SP-921
Device Facts
| Record ID | K192264 |
|---|---|
| Device Name | HIVOX Spopad EMS SP-911, SP-921 |
| Applicant | Hivox Biotek, Inc. |
| Product Code | NGX · Physical Medicine |
| Decision Date | Nov 8, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
Indications for 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-911, SP-921) are battery-operated, 1-channel electrical muscle stimulators. Device generates symmetrical biphasic electrical pulses delivered to skin via integrated electrodes (2 for SP-911; 4 for SP-921). Used for muscle toning, firming, and strengthening. Operated by user in home/non-clinical setting. Device features automatic shut-off and user-controlled intensity. Output signals are delivered through skin to induce muscle contraction. Benefits include non-medication muscle training and self-exercise. Healthcare providers do not interact with output; device is for consumer self-use.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including shelf-life testing, performance verification, and usability validation.
Technological Characteristics
Powered by 3V CR2032 battery. Silicone housing. Symmetrical biphasic rectangular waveform. Pulse duration 400 μs. Frequency 3/4/5 Hz (SP-911) or 2/4/25 Hz (SP-921). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Microprocessor-controlled.
Indications for Use
Indicated for improvement of muscle tone and firmness, and strengthening muscles in arms, abdomen, thighs, and buttocks. Not for therapy or treatment of medical conditions or 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
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 8, 2019
Hivox Biotek Inc. Marx Lee Regulatory Affairs Representative 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City, TW 24158
Re: K192264
Trade/Device Name: HIVOX Spopad EMS SP-911, SP-921 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 7, 2019 Received: October 9, 2019
Dear Marx Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for: Vivek Pinto, Ph.D. Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K192264
Device Name HIVOX Spopad EMS SP-911, SP-921
#### 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Section 6
# 510(k) Summary
{4}------------------------------------------------
# 510(k) SUMMARY
| 5.1 Type of Submission | Special |
|------------------------|---------------------------------------------------------------------------------|
| 5.2 Date of Summary | November 8, 2019 |
| 5.3 Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 24158, Taiwan, R.O.C. |
| Phone: | +886-2-8511-2668 |
| Fax: | +886-2-8511-2669 |
| Contact: | Marx Lee |
| | (Marx.Lee@hivox-biotek.com) |
## 5.4 Identification of the Subject Device
| Proprietary/Trade name: | HIVOX Spopad EMS |
|------------------------------|-------------------------|
| Models: | SP-911, SP-921 |
| Classification product code: | NGX |
| Regulation number: | 890.5850 |
| Regulation description: | Power muscle stimulator |
| Review panel: | Physical Medicine |
| Device class: | II |
## 5.5 Identification of the Predicate Device
| Proprietary/Trade name: | HIVOX Spopad EMS |
|------------------------------|-------------------------|
| Models: | SP-910, SP-920 |
| 510(k) number: | K141921 |
| Classification product code: | NGX |
| Regulation number: | 890.5850 |
| Regulation description: | Power muscle stimulator |
| Review panel: | Physical Medicine |
| Device class: | II |
{5}------------------------------------------------
## 5.6 Intended Use / Indication for Use of the Device
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.
#### 5.7 Description of the Device
EMS, Electrical Muscle Stimulator, which improves, tones, firms & strengthens muscle and relaxes stiff muscle through the skin. It is recognized as a clinically proven, effective, non-medication method of training muscle from certain causes. It manages muscle strengthen, toning and firming. It is also free from side effects when used properly, and can also be used as a simple means of self-training.
HIVOX Spopad EMS SP series, SP-911 and SP-921 are the proposed devices for the 510(k) submission. 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 therapy or for the treatment of any medical conditions or diseases.
SP-911 and SP-921 are 1-channel battery-operated-user-friendly muscle stimulation system specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-911 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-921 comprises 4 electrodes, which connect 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.
#### 5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, HIVOX Spopad EMS SP-911 and SP-921.
- Shelf-Life testing
- Performance verification
- Usability validation
All the test result demonstrate HIVOX Spopad EMS SP-911 and SP-921 meet the requirement of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
{6}------------------------------------------------
# 5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
# 5.10 Comparison of Differences and Substantial Equivalence Determination 5.10.1 Comparison between SP-910 and SP-911
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Device name | HIVOX Spopad<br>EMS | HIVOX Spopad<br>EMS | N/A | |
| Model name | SP-911 | SP-910 | N/A | |
| 510(k) number | K192264 | K141921 | N/A | |
| Product code | NGX | NGX | Identical | |
| Classification name | Powered Muscle<br>Stimulator | Powered Muscle<br>Stimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication 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<br>areas.<br>Not intended for<br>use in any<br>therapy or for the<br>treatment of any<br>medical<br>conditions or<br>diseases. | 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<br>areas.<br>Not intended for<br>use in any<br>therapy or for the<br>treatment of any<br>medical<br>conditions or<br>diseases. | Identical | |
| Technology | Electrical Muscle<br>Stimulation | Electrical Muscle<br>Stimulation | Identical | |
| Size (L x W x H, inch) | 8.15 × 4.06 × | 9.41 × 2.76 × | Different but | |
| | 0.51 | 0.45 | does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device | |
| Weight (g) | 24.2 | 35.8 | Different but<br>does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device | |
| Power source | 3 V battery × 1 | 3 V battery × 1 | Identical | |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical | |
| Patient Leakage Current<br>Normal Condition (μΑ) | 2.0 | 2.0 | Identical | |
| Patient Leakage Current<br>Single Fault Condition (μΑ) | 2.1 | 2.1 | Identical | |
| Method of channel isolation | Single channel | Single channel | Identical | |
| Average DC current through<br>electrodes when device is on but<br>no pulses are being applied (μΑ) | 0 | 0 | Identical | |
| Number of output modes | 1 | 1 | Identical | |
| Regulated current or regulated<br>voltage? | Voltage | Voltage | Identical | |
| Software / Firmware /<br>Microprocessor control? | Yes | Yes | Identical | |
| Automatic overload trip? | No | No | Identical | |
| Automatic no-load trip? | No | No | Identical | |
| Automatic shut-off? | Yes | Yes | Identical | |
| User overrides control? | Yes | Yes | Identical | |
| Indicator display –<br>On / Off Status | No | No | Identical | |
| Indicator display – | No | No | Identical | |
| Low battery? | | | | |
| Indicator display –<br>Voltage / Current level | No | No | Identical | |
| Timer range (minutes) | 20 | 20 | Identical | |
| Compliance with voluntary<br>standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Identical | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical | |
| Output waveform | Symmetrical<br>biphasic | Symmetrical<br>biphasic | Identical | |
| Shape | Rectangular | Rectangular | Identical | |
| Duration of primary<br>(depolarizing) phase | 0 | 0 | Identical | |
| Pulse duration (μs) | 400 | 400 | Identical | |
| Maximum output voltage<br>(V, ±10%) at 500 Ω | 52 | 52 | Identical | |
| Maximum output voltage<br>(V, ±10%) at 2k Ω | 102 | 102 | Identical | |
| Maximum output voltage<br>(V, ±10%) at 10k Ω | 150 | 150 | Identical | |
| Maximum output current<br>(mA, ±10%) at 500 Ω | 104 | 104 | Identical | |
| Maximum output current<br>(mA, ±10%) at 2k Ω | 51 | 51 | Identical | |
| Maximum output current<br>(mA, ±10%) at 10k Ω | 15 | 15 | Identical | |
| Frequency (Hz) | 3/4/5 | 3/4/5 | Identical | |
| Net charge per pulse at 500 Ω<br>(μC) | 0.416 | 0.416 | Identical | |
| Maximum charge at 500 Ω (μC) | 41.6 | 41.6 | Identical | |
| Conductive surface area (cm²) | 62.20<br>(Two electrodes) | 87.58<br>(Two electrodes) | Identical | |
| Maximum current density at 500 | 1.672 | 1.187 | Different but | |
| Ω (mA/cm²) | | | | does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device |
| Maximum average power density<br>at 500 Ω (W/cm²) | | 0.0869 | 0.0617 | Different but<br>does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device |
| | | | | |
| Burst<br>mode | A. Pulse per burst | N/A | N/A | Identical |
| | B. Burst per second | N/A | N/A | Identical |
| | C. Burst duration (sec) | N/A | N/A | Identical |
| | D. Duty cycle | N/A | N/A | Identical |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
## 5.10.2 Comparison between SP-920 and SP-921
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination | |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------|
| Device name | HIVOX Spopad<br>EMS | HIVOX Spopad<br>EMS | N/A | |
| Model name | SP-921 | SP-920 | | |
| 510(k) number | K192264 | K141921 | | |
| Product code | NGX | NGX | Identical | |
| Classification name | Powered Muscle<br>Stimulator | Powered Muscle<br>Stimulator | Identical | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | |
| Indication for use | Indicated for the<br>improvement of<br>muscle tone and<br>firmness, for<br>strengthening | Indicated for the<br>improvement of<br>muscle tone and<br>firmness, for<br>strengthening | Identical | |
| | | | | |
| | muscles in arms,<br>abdomen, thighs,<br>and buttocks<br>areas.<br>Not intended for<br>use in any<br>therapy or for the<br>treatment of any<br>medical<br>conditions or<br>diseases. | muscles in arms,<br>abdomen, thighs,<br>and buttocks<br>areas.<br>Not intended for<br>use in any<br>therapy or for the<br>treatment of any<br>medical<br>conditions or<br>diseases. | | |
| Technology | Electrical Muscle<br>Stimulation | Electrical Muscle<br>Stimulation | Identical | |
| | | | Different but<br>does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device | |
| Size (L × W × H, inch) | $7.17 × 6.81 ×0.51$ | $6.69 × 6.69 ×0.51$ | | |
| | | | Different but<br>does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device | |
| Weight (g) | 48.3 | 52.6 | | |
| Power source | 3 V battery × 1 | 3 V battery × 1 | Identical | |
| Method of Line Current Isolation | Battery supply | Battery supply | Identical | |
| Patient Leakage Current<br>Normal Condition (μΑ) | 2.0 | 2.0 | Identical | |
| Patient Leakage Current<br>Single Fault Condition (μΑ) | 2.1 | 2.1 | Identical | |
| Method of channel isolation | Single channel | Single channel | Identical | |
| Average DC current through | 0 | 0 | Identical | |
| electrodes when device is on but<br>no pulses are being applied (μΑ) | | | | |
| Number of output modes | 1 | 1 | Identical | |
| Regulated current or regulated<br>voltage? | Voltage | Voltage | Identical | |
| Software / Firmware /<br>Microprocessor control? | Yes | Yes | Identical | |
| Automatic overload trip? | No | No | Identical | |
| Automatic no-load trip? | No | No | Identical | |
| Automatic shut-off? | Yes | Yes | Identical | |
| User overrides control? | Yes | Yes | Identical | |
| Indicator display –<br>On / Off Status | No | No | Identical | |
| Indicator display –<br>Low battery? | No | No | Identical | |
| Indicator display –<br>Voltage / Current level | No | No | Identical | |
| Timer range (minutes) | 20 | 20 | Identical | |
| Compliance with voluntary<br>standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Identical | |
| Compliance with 21 CFR 898? | Yes | Yes | Identical | |
| Housing material and construction | Silicone | Silicone | Identical |…
