Electronic Pulse Stimulator
Device Facts
| Record ID | K183674 |
|---|---|
| Device Name | Electronic Pulse Stimulator |
| Applicant | Shenzhen Leading Perfection Technology Co., Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | Oct 11, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance. Mode 2 (TENS): 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
Electronic Pulse Stimulator (Model S3) is an OTC powered muscle stimulator and TENS device. It delivers electrical pulses to the user's skin via electrode pads (conductive hydrogel or PU fabric with silver paste). The device features a main unit with power, intensity (+/-), and mode selection buttons. It operates in two modes: EMS for muscle training and TENS for pain relief. The device is intended for use on the hips, arms, legs, abdomen, and feet. Users attach the device to electrode pads via a snap-on connector. The device is battery-operated (USB rechargeable). It provides non-invasive electrical stimulation to help users manage muscle soreness or improve muscle performance. Healthcare providers do not operate the device; it is for patient self-use in a home environment.
Clinical Evidence
Bench testing only. Performance data included biocompatibility testing (ISO 10993-1), electrical safety and EMC testing (IEC 60601-1, 60601-1-11, 60601-2-10, 60601-1-2), software verification, waveform output verification, electrode adhesion testing (AAMI EC 12:2000), and shelf-life testing (ASTM F 1980-07).
Technological Characteristics
Materials: ABS housing, conductive hydrogel or PU fabric/silver paste electrodes. Energy: 3.7V USB rechargeable battery. Output: Single-channel, biphasic rectangular pulses. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5/10. Software: Microprocessor-controlled with automatic overload/no-load trip and auto-shutoff.
Indications for Use
Indicated for adult patients requiring temporary pain relief (TENS) for sore/aching muscles in shoulder, waist, back, neck, arms, legs, abdomen, and bottom due to exercise or household strain, or muscle stimulation (PMS) to improve/facilitate performance of healthy muscles.
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
- PulseRelief (K151035)
- HIVOX OTC Electrical Stimulator /SEM44 (K171803)
- Health Expert Electronic Stimulator, Model AST-300C and AST-300D (K133929)
Submission Summary (Full Text)
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Shenzhen Leading Perfection Technology 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, Guangdong 518000 CN
Re: K183674
Trade/Device Name: Electronic Pulse Stimulator, Model S3 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX Dated: March 30, 2019 Received: September 9, 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 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, PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K183674
Device Name Electronic Pulse Stimulator (Model: S3)
Indications for Use (Describe) Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
Mode 2 (TENS):
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
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 21CFR 807.92.
# Date: 2019-01-25
#### Submitter I.
Shenzhen Leading Perfection Technology Co., Ltd 4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi Road, Jiuwei, Hangcheng Street, Bao'an District, Shenzhen, China
Tel.: +86 755 2999 1449 Tax: +86 755 2371 3490
Simon Hou (General Manager) Tel: +86 134 8075 8801 Email: info@leadingind.com
# II. Device
Type of 510(k): Traditional Common Name: Powered muscle stimulator Trade Name: Electronic Pulse Stimulator Model: S3 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Review Panel: Neurology Regulatory Class: II Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890
# III. Predicate Device
| Applicant | Predicate Device | 510(k) Number | Approval Date |
|---------------------------------------------------|-------------------------------------------------------------------------|---------------|-------------------|
| Philips<br>Lifstyle | (Primary):<br>PulseRelief | K151035 | July 21,2015 |
| HIVOX BIOTEK INC. | HIVOX OTC Electrical<br>Stimulator /SEM44 | K171803 | November 29, 2017 |
| Shenzhen<br>OSTO<br>Technology Company<br>Limited | Health Expert Electronic<br>Stimulator, Model AST-<br>300C and AST-300D | K133929 | November 12, 2014 |
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## IV. Device Description
Electronic Pulse Stimulator is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. It has two modes of different pulse frequencies, mode 1 uses Electrical Muscle Stimulation (EMS) technology for muscle training and mode 2 uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to temporary relieve pain. The device includes operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button, and could be attached and detached to the electrode pad through the snap-on connector.
In additional, according to different simulation-needed bodies, users can choose the four types of electrode pad based on their own situation. Electronic Pulse Stimulator is suitable for the simulation-needed bodies including hips, arms and legs, abdomen, and feet.
# V. Indications for Use
Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
Mode 2 (TENS): To be used for temporary relief of pain associate 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.
# VI. Comparison of Technological Characteristics With the Predicate Devices
The Electronic Pulse Stimulator is substantially equivalent to the predicate devices based on intended use, design, specifications and performance.
The Electronic Pulse Stimulator raises no safety or efficacy concerns when compared to the following 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 predicate is provided below:
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| Comparison Elements | Subiect Device | (Primary) Predicate Device K151035 | Predicate Device K171803 | Predicate Device K133929 | Comparison | |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------|
| Trade Name/Model | Electronic Stimulator/S3 | PulseRelief | HIVOX OTC Electrical Stimulator/SEM44 | Health Expert Electronic Stimulator, Model AST-/300C and AST-300D | / | |
| 510(k) Number | To be assigned | K151035 | K171803 | K133929 | / | |
| Manufacturer | Shenzhen Leading Perfection Technology Co., Ltd | Philips Lifsty | HIVOX BIOTEK INC. | Shenzhen OSTO Technology Company Limited | / | |
| Regulation Number | 21CFR 882.5890 | 21CFR 882.5890 and 890.5850 | 21CFR 882.5890 | 21 CFR 882.5890 | SE | |
| Device Class | II | II | II | II | SE | |
| Product Code | NUH, NGX | NUH, NGX | NUH, NGX | NUH, NGX | SE NOTE 1 | |
| Indication for Use/Intended Use | Mode 1(PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.<br>Mode 2(TENS): To be used for temporary relief of pain associate with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and | The OTC TENS/EMS stimulator PulseRelief 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 | SEM44 (EMS): The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.<br>SEM44 (TENS): The device is designed to be used for temporary relief | PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.<br>TENS (Mode 9~25) To be used for temporary relief of pain associated with sore and aching muscles in | SE NOTE 1 | |
| extremities (leg),<br>abdomen and bottom<br>due to strain from<br>exercise or normal<br>household work<br>activities | | | | | | |
| Comparison<br>Elements | Subject Device | (Primary) Predicate<br>Device K151035 | Predicate Device<br>K171803 | Predicate Device<br>K133929 | Comparison | |
| | | lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household work<br>activities.<br><br>It should be applied to<br>normal, healthy, dry<br>and clean skin of adult<br>patients, and is to be<br>used for stimulate<br>healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance. | of pain associated with<br>sore and aching muscles<br>in the shoulder, waist,<br>back, neck, upper<br>extremities (arm), lower<br>extremities (leg),<br>abdomen and bottom due<br>to strain from exercise or<br>normal household work<br>activities. | the shoulder, waist, back,<br>back of the neck, arm, leg,<br>and foot due to strain from<br>exercise or normal household<br>work activities by applying<br>current to stimulate nerve. | | |
| Shape of electrodes | Rectangle | Square | Unknown | Rectangle | SE | |
| Anatomical application | Arm, leg, abdomen,<br>hip, feet | Shoulder, waist, back,<br>upper extremities<br>(arm), and lower<br>extremities (leg) | Shoulder, waist, back,<br>neck, upper extremities<br>(arm), lower extremities<br>(leg), abdomen and<br>bottom | Shoulder, waist, back, back<br>of the neck, arm, leg, and<br>foot | SE | |
| Applicable People | Adults | Adults | Adults | Adults | SE | |
| Location for Use | OTC | OTC | OTC | OTC | SE | |
| Basic Unit Characteristics | | | | | | |
| Comparison<br>Elements | Subiect Device | (Primary)<br>Predicate Device<br>K151035 | Predicate Device<br>K171803 | Predicate Device<br>K133929 | Comparison | |
| Power Supply | USB rechargeable<br>battery, 3.7V | Li-ion 3.7V 500mAH | 4.5V (batteries, 3×1.5V AAA) | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | SE<br>NOTE 2 | |
| Method of Line<br>Current Isolation | N/A | N/A | N/A | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | < 0.1 | <10μA | N/A | AC: 54.5μA, DC: 0.5μA | SE | |
| Signal Fault<br>Current<br>Condition | N/A | <50μA | N/A | AC:120.0μA,<br>DC: 0.6μA | SE | |
| Number of Output<br>Modes | 2 (1 TENS and 1 EMS) | EMS: 5<br>TENS:15 | EMS: 35<br>TENS:15 | EMS: 8<br>TENS:17 | SE<br>NOTE 2 | |
| Number of Output<br>Channels | 1 | 1 | 2 | 2 | SE<br>NOTE 2 | |
| Synchronous or<br>Alternating? | N/A | N/A | Synchronous | Synchronous | SE | |
| Method of Channel<br>Isolation | N/A | N/A | By electrical circuit and<br>software | Voltage Transform<br>Isolation<br>"BODY▼" and<br>" BODY▼" buttons for<br>body channel,<br>" SOLE ▲" and<br>"SOLE▼" buttons for<br>feet channel | SE | |
| Comparison<br>Elements | Subiect Device | (Primary) Predicate<br>Device K151035 | Predicate Device<br>K171803 | Predicate Device<br>K133929 | Comparison | |
| Software /Firmware<br>/Microprocessor<br>Control? | Yes | Yes | Yes | Yes | SE | |
| | Automatic Overload<br>Trip? | Yes | Yes | Yes | No | SE |
| Yes | | Yes | Yes | No | SE | |
| Automatic No-Load<br>Trip? | | Yes | Yes | Yes | No | SE |
| Automatic Shut OFF? | | Yes | Yes | Yes | Yes | SE |
| Patient Override<br>Control? | | Yes | Yes | Yes | Yes | SE |
| Indicat<br>or<br>Display | On/Off<br>Status? | Yes | Yes | Yes | Yes | SE |
| | Low<br>Battery? | Yes | Yes | Yes | No | SE |
| | Voltage/<br>Current<br>Level? | No | Yes | Yes | Yes | SE |
| Timer Range | | 25 minutes | 1~59minutes and<br>continuous | 5~100minutes | 25 minutes | SE<br>NOTE 2 |
| Compliance<br>with<br>Voluntary Standards? | | IEC60601-1-2<br>IEC60601-1<br>IEC60601-11 | IEC60601-1-2<br>IEC60601-1<br>IEC60601-2-10 | IEC60601-1-2<br>IEC60601-1<br>IEC60601-2-10 | IEC60601-1-2<br>IEC60601-1<br>IEC60601-2-10 | SE |
| Comparison<br>Elements | | Subiect Device | (Primary)<br>Predicate<br>Device K151035 | Predicate Device<br>K171803 | Predicate Device<br>K133929 | Comparison |
| | | IEC60601-2-10<br>ISO10993-5/10 | ISO10993-5/10 | ISO10993-5/10 | ISO10993-5/10 | |
| Compliance<br>with<br>21CFR898 | | Yes | Yes | Yes | Yes | SE |
| Weight | | 14.5g(with battery) | 62g (excl. electrodes) | 89g (including belt clip,<br>without batteries)<br>123g (including belt clip,<br>and batteries) | 2Kg (Without accessories) | SE<br>NOTE 3 |
| Dimensions | | Ф4.2cm×1.38cm | 54×54×14mm (unit) | 132 x 63 x<br>29.5mm(including<br>clip) | 428mm x 428.8mm x<br>185mm | SE<br>NOTE 3 |
| Housing Materials and<br>Construction<br>(Main<br>unit) | | ABS | ABS, PC | ABS | ABS | SE |
| Output Specifications | | | | | | |
| Waveform | | Symmetrical<br>rectangular | Biphasic, rectangular | Biphasic, square | Pulsed, symmetric,<br>Biphasic, Rectangular, | SE<br>NOTE 4 |
| Maxim<br>um<br>Output | $@500Ω$ | 40±20% | 31±20% | 100±10 % (50±10 %(Vp)) | 44±10% | SE<br>NOTE 4 |
| Voltage<br>(Volts, | $@2kΩ$ | 64±20% | 69±20% | 180±10 % (90±10 %(Vp)) | 80±10% | SE<br>NOTE 4 |
| Comparison<br>Elements | | Subject Device | (Primary)<br>Predicate<br>Device K151035 | Predicate Device<br>K171803 | Predicate Device<br>K133929 | Comparison |
| Vp) | @10kΩ | 76±20% | 70±20% | 250±10 % (125±10 %(Vp)) | 112±10% | SE<br>NOTE 4 |
| Maximum<br>Output<br>Current<br>(mA) | @500Ω | 80±20% | 62±20% | 200±10 % (100±10 %(Ip)) | 88±10% | SE<br>NOTE 4 |
| | @2kΩ | 32±20% | 34±20% | 90±10 % (45±10 %(Ip)) | 40±10% | SE<br>NOTE 4 |
| | @10kΩ | 7.6±20% | 7±20% | 25±10 % (12.5±10 %(Ip)) | 11.2±10% | SE<br>NOTE 4 |
| Pulse Width | | 200μs | TENS: 60~350μs<br>EMS: 150~350μs | 50-450μs | 120μs | SE<br>NOTE 4 |
| Frequency (Hz) | | Mode 1: 4-35Hz<br>Mode 2: 4-41Hz | TENS: 1~100Hz<br>EMS: 45~65Hz | 1-150Hz | 77.3Hz | SE<br>NOTE 4 |
| Maximum<br>Phase<br>Charge (μC) @500Ω | | 22.31 | TENS: 1.6~6.8<br>EMS: 4.7~10.9 | 0.045 | 12.78μC @ 500Ω | SE<br>NOTE 4 |
| Maximum<br>Density<br>@500Ω | Current<br>(mA/cm²) |…
