Electronic Pulse Stimulator

K221992 · Beijing Choice Electronic Technology Co., Ltd. · NUH · Oct 21, 2022 · Neurology

Device Facts

• Record ID: K221992
• Device Name: Electronic Pulse Stimulator
• Applicant: Beijing Choice Electronic Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Oct 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.

Device Story

Electronic Pulse Stimulator (MDTS100) is a battery-powered transcutaneous electrical nerve stimulator (TENS) for OTC home use. Device delivers pulsed monophasic electrical current to muscles via adhesive electrode pads placed on skin. User selects from 7 stimulation modes via front-panel button. Device features include automatic shut-off, no-load trip, and patient override control. Although device includes Bluetooth hardware, functionality is disabled in this model. Healthcare providers do not operate the device; patients self-administer therapy to relieve muscle soreness. Output parameters (voltage, current, frequency) are fixed within safety limits to ensure therapeutic benefit without requiring clinical supervision.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, -5, -10), and software verification/validation.

Technological Characteristics

Battery-powered TENS device; ABS plastic enclosure. Output: pulsed monophasic rectangular waveform; 0.9Hz-82Hz frequency; 35µs pulse duration. Connectivity: Bluetooth (hardware present but disabled). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10. Biocompatibility: ISO 10993-1, 5, 10. Software: Moderate level of concern.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities, and lower extremities due to strain from exercise or normal household and work activities in adults.

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

• Electronic Pulse Stimulator MDTS100 (K160508)

Submission Summary (Full Text)

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October 21, 2022

Beijing Choice Electronic Technology Co., Ltd. c/o Haiying Zhao Quality Director North Building 3F, No.9 Shuangyuan Road Badachu Hi-tech Zone, Shijingshan District Beijing, China 100041

Re: K221992

Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: September 15, 2022 Received: September 19, 2022

Dear Haiying Zhao:

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.

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Pamela D. Scott Assistant Director 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

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### Indications for Use

510(k) Number (if known) K221992

Device Name Electronic Pulse Stimulator

Indications for Use (Describe)

The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.

| 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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# Section II 510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

There is no prior submission for the device.

## 3.1 Submitter Information

#### ● Manufacturer Name:

Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. 2nd Floor, 3rd Floor and Room 410-412 4th Floor, No. 2 Building, No. 9 Shuangyuan Road , Shijingshan District BEIJING, 100041, P.R.China

#### ● Contact Person:

Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: [phone] Fax: [phone] Email: [e-mail]

- Date prepared :June 24, 2022 ●
### 3.2 Proposed Device Information

Device Common Name: Transcutaneous Electrical Nerve Stimulator, OTC

Device Trade/Proprietary Name: Electronic Pulse Stimulator

Model: MDTS100

Classification Name: Stimulator, Nerve, Transcutaneous,Over-The-Counter

Regulation Number: 882.5890

Product Code: NUH

Class: II

Panel: Neurology

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## 3.3 Predicate Device

#### 510(k) Number: K160508

Common Name: Transcutaneous Electrical Nerve Stimulator, OTC

Device Trade/Proprietary Name: Electronic Pulse Stimulator

Model: MDTS100

Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code: NUH

Regulation Number: 882.5890

Device Class: II

Panel: Neurology

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

Intended Use: The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.

## 3.4 Device Description

The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit.

The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness.

Its accessories include connecting wires, electrode pads, 2 AAA batteries.

The device is for over the counter use.

The device does not contain drug or biological products.

The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.

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### 3.5 Comparison list of the technological characteristics

| Comparison Elements | | | | Proposed Device | Predicate Device | Remark |
|---------------------------------------------------------------------------------------------------|----------------------|----------------------------|------------------------------------------------|---------------------------------------------------------|----------------------------------------------|--------|
| 510(k) number | | | | NA | K160508 | |
| Device Name/Model | | | | Electronic Pulse Stimulator MDTS100 | Electronic<br>Pulse<br>Stimulator<br>MDTS100 | |
| Manufacturer | | | Beijing Choice Electronic Technology Co., Ltd. | Beijing<br>Choice<br>Electronic<br>Technology Co., Ltd. | Same | |
| | -Method<br>Isolation | of<br>Line | Current | N/A for DC current | N/A for DC current | Same |
| Power | -Patient | -Normal condition | | < 10μΑ | <10μA | Same |
| Source(s) | Leakage<br>Current | -Single<br>condiction | fault | <50uA | <50μA | Same |
| Average DC current through<br>electrodes when device is on but no<br>pulses are being applied(uA) | | | < 10μΑ | < 10μΑ | Same | |
| Number of Output Modes | | | 7 | 7 | Same | |
| Number of Output<br>-Synchronous<br>or<br>Channels<br>Alternating? | | | Alternating | Alternating | Same | |
| | | of<br>-Method<br>Isolation | Channel | No | No | Same |

Table 2-1 Basic Unit Characteristics Comparison Table between the Proposed Device and Predicate Device

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| Regulated Current or Regulated Voltage? | Regulated Voltage | Regulated Voltage | Same | |
|-------------------------------------------------------------------------------|--------------------------|-----------------------------|---------|------|
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |
| Automatic Overload Trip | No | No | Same | |
| Automatic No-Load Trip? | Yes | Yes | Same | |
| Automatic Shut Off? | Yes | Yes | Same | |
| Patient Override Control? | Yes | Yes | Same | |
| Indicator<br>Display: | - On/Off Status? | Yes | Yes | Same |
| | - Low Battery? | Yes | Yes | Same |
| | -Voltage/Current Level? | Yes | Yes | Same |
| Timer Range (minutes) | 20 minutes | 20 minutes | Same | |
| Compliance with Voluntary Standards? | Yes | Yes | Same | |
| Compliance* with 21 CFR 898?<br>(*Becomes mandatory beginning May 9,<br>2000) | Yes | Yes | Same | |
| Weight | 2.3 oz(Battery Excluded) | 2.2 oz. (Battery Excluded ) | Similar | |
| Dimensions (in.) [W x H x D] | 2.17x 5.12x0.79 | 2.17x 5.12x0.87 | Similar | |
| Housing Materials and Construction | Enclosure: ABS | Enclosure: ABS | Same | |

### Premarket Notification 510(k) Submission—Section III 510(k) Summary

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| Comparison Elements | Proposed Device | Predicate Device | Remark | |
|------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------|----------|------------|
| Waveform (e.g., pulsed monophasic, biphasic) | pulsed monophasic | pulsed monophasic | Same | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | Same | |
| Maximum Output Voltage (specify units)<br>(+/- 20 %) | 150V @ 500 Ω<br>160V @ 2 kΩ<br>165V @ 10 kΩ | 150V @ 500 Ω<br>160V @ 2 kΩ<br>165V @ 10 kΩ | Same | |
| Maximum Output Current (specify units)<br>(+/- %) | 300mA @ 500 Ω<br>80mA @ 2 kΩ<br>16.5mA @ 10 kΩ | 300mA @ 500 Ω<br>80mA @ 2 kΩ<br>16.5mA @ 10 kΩ | Same | |
| Duration of primary (depolarizing) phase (µsec) | 0 µsec | 0 µsec | Same | |
| Pulse Duration((µsec)) | 35 µsec | 35 µsec | Same | |
| Frequency(Hz) | 0.9Hz~82Hz | 0.9Hz~82Hz | Same | |
| Net Charge (µC per pulse)<br>(If zero, state method of achieving zero net charge.) | 42µC @ 500 Ω | 42µC @ 500 Ω | Same | |
| Maximum Phase Charge, (µC)@500Ω | 42µC | 42µC | Same | |
| Maximum Current Density, (mA/cm | 3.3mA/cm2@1.57"×1.57"Electrode Pad | 3.3mA/cm2@1.57"×1.57"Electrode Pad | Same | |
| Maximum Average Current (average absolute value), mA | 2.8mA | 2.8mA | Same | |
| Burst Mode (i.e., pulse trains) | a. Pulses per burst | 197 | 197 | Same |
| | b. Bursts per second | 0.185 | 0.185 | Same |
| | c. Burst duration (seconds) | 2.4s | 2.4s | Same |
| | d. Duty Cycle [Line (b) x Line (c)] | 0.44 | 0.44 | Same |
| ON Time (seconds) | | ≤1second | ≤1second | Same |
| OFF Time (seconds) | | ≤1second | ≤1second | Same |
| Cybersecurity | | FDA Guidance for Content of Premarket Submission for Management of Cybersecurity in Medical Device | / | Difference |
| Wireless Testing | | Conform to FCC and wireless coexistence test | / | Difference |

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#### Premarket Notification 510(k) Submission-Section III 510(k) Summary

#### Conclusion:

The proposed device and the predicate device have same performance specification. There are very small differences in the weight and dimensions of the two devices, which have no impact on the safety and effectiveness.

Compared with the predicate device the proposed device has bluetooth function. We have conducted the wireless test and cybersecurity analysis to verify the basic safety and the essential performance. The Bluetooth function in this model of the device is not used.

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### 3.6 Intended use

The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.

## 3.7 Testing

### Biocompatibility Testing

The material in contact with the patient of the proposed device is self adhesive electrode, which has been conducted the biocompatibility test according to the requirement of the ISO 10993-1, ISO 10993-5, ISO 10993-10.

### Electrical safety and electromagnetic compatibility (EMC)

The proposed device Electronic Pulse Stimulator MDTS100 is tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 to evaluate the electrical safety and EMC.

#### Performance Test-Bench

We have also conducted IEC 60601-2-10 and other performance tests including maximum output amplitudes, pulse durations, pulse repetition frequencies, maximum output current, supply voltage fluctuations, supply voltage fluctuations, Cleaning Test , High and Low Temperature & Humidity Test, Shelf-life Test as so on .

#### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

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#### Cybersecurity testing

Cybersecurity testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Postmarket Management of Cybersecurity in Medical Devices." Cybersecurity testing was performed because of the Bluetooth function. Please note that the Bluetooth function in this model of the device is not used.

#### Wireless Testing

We have conducted the FCC test and wireless coexistence for the proposed device MDTS 100. The test reports are presented in Electromagnetic Compatibility and Electrical Safety. Wireless testing was performed because of the Bluetooth function. Please note that the Bluetooth function in this model of the device is not used.

#### Clinical Testing

The clinical testing was not needed in this submission.

### 3.8 Determination of substantial equivalence

The proposed device of the Electronic Pulse Stimulator MDTS100 has the same classification information, same intended use, same design principle, same product design and specifications as the predicate device. So, the proposed device are Substantially Equivalent (SE) to the predicate device which is US legally market device.