Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard electrical stimulation technologies (EMS and TENS) and do not mention any AI or ML components, algorithms, or data processing related to learning or adaptation.

Therapeutic

Yes.
The device is used to stimulate muscles for performance improvement and to provide temporary pain relief, which are both therapeutic applications.

Diagnostic

No

The device is an Electronic Pulse Stimulator, designed for therapeutic purposes (muscle stimulation and pain relief) rather than for diagnosing medical conditions. It delivers electrical pulses for treatment, not for identifying diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "Electronic Pulse Stimulator" that "delivers electric pulses generated to the user's skin through the electrodes." It also mentions physical components like "operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button," and "electrode pad through the snap-on connector." This indicates a hardware component that generates and delivers the electrical pulses, making it more than just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body ("in vitro").
Device Function: The provided description clearly states that this device is an "Electronic Pulse Stimulator" that delivers electrical pulses to the user's skin through electrodes. It uses EMS and TENS technology for muscle stimulation and pain relief.
Lack of Sample Analysis: There is no mention of this device analyzing any biological samples from the user. Its function is to apply external electrical stimulation.

Therefore, based on the intended use, device description, and the nature of its operation, this device falls under the category of a physical therapy or pain management device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes

NUH, NGX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mode 2 (TENS): shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom.
Device Description states: hips, arms and legs, abdomen, and feet.

Indicated Patient Age Range

Adults

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility Testing: The direct components of applied parts contacting with the users are electrode pads made of conductive hydrogel or PU fabric (contained sliver paste and conductive oil). The electrode pads are directly purchased from qualified supplier which has been tested and passed the In Vitro Cytotoxicity, Skin Sensitization test in accordance with the ISO10993-1 standards.
Electrical and EMC Safety: Electrical safety and EMC safety testing was performed to, and passed, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, and IEC 60601-1-2.
In addition to the compliance of voluntary standards:

The software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
The waveform test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s.
The adhesion test report has been conducted to verify the maximum duration of use for the electrodes used by the subject device according to the requirements of AAMI EC 12_2000(R) 2010-Section 5.4.
The dispersion and shelf life test report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA guidance –Shelf Life of Medical Device and ASTM F 1980-07 standard.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151035, K171803, K133929

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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
Philips
Lifstyle	(Primary):
PulseRelief	K151035	July 21,2015
HIVOX BIOTEK INC.	HIVOX OTC Electrical
Stimulator /SEM44	K171803	November 29, 2017
Shenzhen
OSTO
Technology Company
Limited	Health Expert Electronic
Stimulator, Model AST-
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.
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.
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.
TENS (Mode 9~25) To be used for temporary relief of pain associated with sore and aching muscles in	SE NOTE 1
extremities (leg),
abdomen and bottom
due to strain from
exercise or normal
household work
activities
Comparison
Elements	Subject Device	(Primary) Predicate
Device K151035	Predicate Device
K171803	Predicate Device
K133929	Comparison
		lower extremities (leg)
due to strain from
exercise or normal
household work
activities.

IEC 60601-1-11 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
IEC 60601-2-10 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests

In addition to the compliance of voluntary standards:

The software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
The waveform test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s
The adhesion test report has been conducted to verify the maximum duration of use for the electrodes used by the subject device according to the requirements of AAMI EC 12_2000(R) 2010-Section 5.4.

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The dispersion and shelf life test report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA guidance –Shelf Life of Medical Device and ASTM F 1980-07 standard.

Summary

Based on the above performance as documented in this application, Electronic Pulse Stimulator was found to have a safety and effectiveness profile that is similar to the predicate devices.

VIII. Conclusions

The subject device Electronic Pulse Stimulator is to be concluded substantial equivalent to its predicate devices.