EMS Belt (Model MC0485)

K183103 · Dongguan Yingfeng Metal & Plastic Products Co., Ltd. · NGX · Sep 18, 2019 · Physical Medicine

Device Facts

• Record ID: K183103
• Device Name: EMS Belt (Model MC0485)
• Applicant: Dongguan Yingfeng Metal & Plastic Products Co., Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Sep 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

EMS Belt (Model MC0485) is a battery-operated, one-channel powered muscle stimulator designed for abdominal muscle exercise. System consists of an electronic stimulator module, a fixation belt, and four integrated TPE electrode pads. Device delivers gentle electrical current to targeted muscles via skin-contacting electrodes. User controls stimulation intensity and parameters via buttons on the controller, with settings displayed on an LCD. Used in home environments by consumers. Output affects muscle performance through electrical stimulation; benefits include improved muscle conditioning. Device includes safety features like overload protection and automatic shut-off.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5/10), electrical safety and EMC (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10), software verification/validation, and performance verification (waveform/output testing and electrode shelf-life per ASTM F1980-07).

Technological Characteristics

Powered muscle stimulator; 4.5V battery-powered (3x1.5V alkaline). Controller housing: ABS plastic; Belt: Multispandex; Electrodes: TPE. Symmetrical rectangular waveform. Output parameters: 1-22Hz frequency, 270µs pulse width. Connectivity: Standalone. Software: Firmware-controlled with moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-10, ISO 10993-5/10, ASTM F1980-07.

Indications for Use

Indicated for healthy individuals to stimulate muscles to improve and facilitate muscle performance. Over-the-counter use.

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

• HIVOX OTC Electrical Stimulator/SEM44 (K171803)
• Health Expert Electronic Stimulator/AST-300C and AST-300D (K133929)
• Revitive IX (OTC)/RIX (K143207)

Reference Devices

• SmartTENS (K143430)

Submission Summary (Full Text)

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September 18, 2019

Dongguan Yingfeng Metal & Plastic Products Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 CN

Re: K183103

Trade/Device Name: EMS Belt (Model: MC0485) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 14, 2019 Received: August 15, 2019

Dear Rain Yip:

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.

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Vivek Pinto, PhD Director (Acting) 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

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# Indications for Use

510(k) Number (if known) K183103

Device Name EMS Belt (Model MC0485)

Indications for Use (Describe)

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

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)

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# 510(k) Summary

# ''510(k) Summary'' as required by 21 CFR Part 807.92.

### Date: 2018-10-26

#### I. Submitter

Dongguan Yingfeng Metal & Plastic Products Co., Ltd Bianpu District, Lianhu Road, Qiaotou Town, Dongguan City, Guangdong Province, P.R.C

Tel.: [phone] Tax: [phone]

Zesheng Chen Quality Manager Tel: [phone] Email: [e-mail]

# II. Device

Name of Device/Model: EMS Belt/MC0485 Common or Usual Name: Powered muscle stimulator Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Regulatory Class: II Product Code: NGX Regulation Number: 21 CFR 890.5850

# III. Predicate Device

The predicate devices are listed as below:

| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---------------------------------------------------|-----------------------------------------------------------------|---------------|---------------|
| Hivox Biotek Inc. | (Primary) HIVOX OTC<br>Electrical Stimulator/SEM44 | K171803 | Nov. 29, 2017 |
| Shenzhen<br>OSTO<br>Technology Company<br>Limited | Health Expert Electronic<br>Stimulator/AST-300C and<br>AST-300D | K133929 | Nov. 12, 2014 |
| Actegy, Ltd | Revitive IX (OTC)/RIX | K143207 | Mar. 23, 2015 |

Reference device(s):

| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|--------------|------------------|---------------|---------------|
|--------------|------------------|---------------|---------------|

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| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|----------------------------------|------------------|---------------|---------------|
| EasyMed Instruments<br>Co., Ltd. | SmartTENS | K143430 | May 29, 2015 |

# IV. Device Description

MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt.

Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt.

The stimulator sends gentle electrical current to targeted muscle area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.

# V. Indications for Use

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

# VI. Comparison of Technological Characteristics With the Predicate Device

The EMS Belt is substantially equivalent to the predicated device based on intended use, design, specifications and performance. It raises no safety or efficacy concerns when compared to the predicate devices.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicates is provided below:

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| Comparison Elements | Subject Device | Primary Predicate Device<br>K171803 | Predicate Device<br>K133929 | Predicate Device<br>K143207 | Reference Device<br>K143430 | SE | | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------|--|
| Trade Name/Model | EMS Belt/MC0485 | HIVOX OTC Electrical<br>Stimulator/SEM44 | Health Expert Electronic<br>Stimulator/AST-300C and<br>AST-300D | Revitive IX (OTC)/RIX | SmartTENS | / | | |
| 510(k) Number | To be assigned | K171803 | K133929 | K143207 | K143430 | / | | |
| Regulation Number | 21CFR 890.5850 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | 21CFR 882.5890 | SE | | |
| Device Class | II | II | II | II | II | SE | | |
| Product Code | NGX | NUH, NGX | NUH, NGX | NUH, NGX | NUH | SE<br>NOTE 1 | | |
| Indication<br>for<br>Use/Intended Use | To be used to<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | SEM44 (EMS): The device<br>is designed to be used for<br>stimulate healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance.<br>SEM44 (TENS): The device<br>is designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm),<br>lower extremities (leg),<br>abdomen and bottom due to<br>strain from exercise or<br>normal household work<br>activities. | PMS (Mode 1~8): It is<br>intended to stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance.<br>TENS (Mode 9~25): To be<br>used for temporary relief of<br>pain associated with sore and<br>aching muscles in the<br>shoulder, waist, back, back<br>of the neck, arm, leg, and<br>foot due to strain from<br>exercise or normal<br>household work activities by<br>applying current to stimulate<br>nerve. | To temporarily increase<br>local blood circulation in<br>healthy leg muscles<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>For temporary relief of<br>pain associated with sore<br>and aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arms)<br>and lower extremities<br>(legs) due to strain from<br>exercise or normal<br>household duties | The device is intended<br>for the relief of pain<br>associated with sore<br>or aching muscles of<br>the low back, arms, or<br>legs due to stain from<br>exercise or normal<br>household and work<br>activities. | SE<br>NOTE 1 | | |
| Comparison Elements | Subject Device | Primary Predicate Device<br>K171803 | Predicate Device<br>K133929 | Predicate Device<br>K143207 | Reference Device<br>K143430 | SE | | |
| Location for Use | OTC | OTC | OTC | OTC | OTC | SE | | |
| Basic Specifications | | | | | | | | |
| Power Supply | 4.5V (3 × 1.5V<br>Alkaline batteries) | 4.5V (batteries, 3x1.5V<br>AAA) | Adaptor Input: 100-240Vac,<br>50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | Power adaptor<br>Input: 100-240V, 50/60Hz,<br>0.18A<br>Output: 5.0VDC, 1.0A | 3.7V rechargeable<br>lithium battery | SE<br>NOTE 2 | | |
| Method of Line Current Isolation | N/A | N/A | Type BF Applied Part | Not publicly available | Not publicly available | SE | | |
| Patient<br>Leakage<br>Current | Normal Condition | N/A | N/A | AC: 54.5µA, DC: 0.5µA | Not publicly available | Not publicly available | SE | |
| | Signal Fault Condition | N/A | N/A | AC: 120.0µA, DC: 0.6μΑ | Not publicly available | Not publicly available | SE | |
| Number of Output<br>Modes | | 10 | EMS: 35<br>TENS: 15 | 25 | 1 | 7 | SE<br>NOTE 2 | |
| | Number of Output<br>Channels | 1 | 2 | 2 | 2 (1 for foot, 1 for body<br>pads) | 1 | SE<br>NOTE 2 | |
| Synchronous or<br>Alternating? | | Alternating | Synchronous | Synchronous | Not publicly available | Not publicly available | SE | |
| Method of Channel<br>Isolation | N/A | By electrical circuit and<br>software | Voltage Transform Isolation<br>"BODY▼" and "BODY▼ "<br>buttons for body channel,<br>"SOLE ▲ " and "SOLE ▼ " | Not publicly available | Not publicly available | SE | | |
| Comparison Elements | | Subject Device | Primary Predicate Device<br>K171803 | Predicate Device<br>K133929 | Predicate Device<br>K143207 | Reference Device<br>K143430 | SE | |
| | | | | buttons for feet channel | | | | |
| Software<br>/Microprocessor<br>Control? | /Firmware | Yes | Yes | Yes | Yes | Yes | SE | |
| Automatic<br>Trip? | Overload | No | Yes | No | Yes | Yes | SE | |
| Automatic<br>Trip? | No-Load | No | Yes | No | Not publicly available | Yes | SE | |
| Automatic Shut OFF? | | Yes | Yes | Yes | Yes | Yes | SE | |
| Patient<br>Control? | Override | Yes | Yes | Yes | Yes | Yes | SE | |
| | On/Off<br>Status? | Yes | Yes | Yes | Not publicly available | Yes | SE | |
| Indicator<br>Display | Low<br>Battery? | Yes | Yes | No | Not publicly available | Yes | SE | |
| | Voltage/C<br>urrent<br>Level? | Yes | Yes | Yes | Not publicly available | Yes | SE | |
| Timer Range | | 5min, 10min, 15min,<br>20min, 25min, 30min | 5~100minutes | 25minutes | 1~60minutes | 20min, 25min, 30min,<br>40min depending on<br>preset program | SE<br>NOTE 2 | |
| Compliance<br>with<br>Voluntary Standards? | | IEC60601-1-2<br>IEC60601-1 | IEC60601-1-2<br>IEC60601-1 | IEC60601-1-2<br>IEC60601-1 | IEC60601-1-2<br>IEC60601-1 | IEC60601-1-2<br>IEC60601-1 | ടല | |
| Comparison Elements | Subject Device | Primary Predicate Device<br>K171803 | Predicate Device<br>K133929 | Predicate Device<br>K143207 | Reference Device<br>K143430 | SE | | |
| | IEC60601-11<br>IEC60601-2-10<br>ISO10993-5/10 | IEC60601-2-10<br>ISO10993-5/10 | IEC60601-2-10<br>ISO10993-5/10 | IEC60601-2-10<br>ISO10993-5/10 | IEC60601-2-10<br>ISO10993-5/10 | | | |
| Compliance<br>with<br>21CFR898 | Yes | Yes | Yes | Yes | Yes | SE | | |
| Weight | 310<br>(without<br>g<br>batteries) | (including<br>belt<br>89g<br>clip,<br>without batteries)<br>123g (including<br>belt clip,<br>and batteries) | 2kg (without accessories) | 1725g (Without PSU) | 64g | SE<br>NOTE 3 | | |
| Dimensions | 78 x 140 x 30mm<br>(controller)<br>430 x 150 x 12mm<br>(belt) | 132<br>ર્ભ્ડ<br>X<br>X<br>29.5mm(including belt clip) | 428 x 428.8 x 185mm | φ360 x 75mm | 155.4x 64.4x 19.1mm | SE<br>NOTE 3 | | |
| Housing Materials and<br>Construction | Controller body: ABS<br>plastic<br>Belt: Mutispandex<br>Electrode pads: TPE | ABS plastic | ABS plastic | ABS.<br>Casing/body<br>footpads NBR | ABS & TPE | SE<br>NOTE 4 | | |
| Biocompatibility | All<br>user<br>directly<br>contacting<br>materials<br>are compliance with<br>ISO10993-5<br>and<br>ISO10993-10. | All user directly contacting<br>materials are compliance<br>with<br>ISO10993-5<br>and<br>ISO10993-10. | All user directly contacting<br>materials<br>are compliance<br>with<br>ISO10993-5<br>and<br>ISO10993-10. | All user directly contacting<br>materials are compliance<br>ISO10993-5<br>and<br>with<br>ISO10993-10. | directly<br>All<br>user<br>contacting<br>materials<br>are compliance with<br>ISO10993-5<br>and<br>ISO10993-10. | SE | | |
| Output Specifications | | | | | | | | |
| Waveform | Symmetrical<br>rectangular | Biphasic, square…