Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

K220578 · Bozhou Rongjian Medical Appliance Co., Ltd. · GZJ · May 25, 2022 · Neurology

Device Facts

• Record ID: K220578
• Device Name: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
• Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: May 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

Device Story

Battery-powered portable TENS device; delivers gentle electrical current to nerves/muscles via skin electrodes; 16 programs (12 standard, 4 editable); 2 output channels; synchronous operation; current-controlled; user-adjustable timer (10-90 min). Used in clinical or home settings; operated by patient or clinician. Device provides symptomatic pain relief; output parameters (voltage, current, frequency) controlled by microprocessor; healthcare providers use device to manage chronic, post-surgical, or post-traumatic pain; benefits include non-pharmacological pain management.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing and compliance with electrical safety and electromagnetic compatibility standards.

Technological Characteristics

ABS housing; 4x1.5V AAA alkaline batteries; 2-channel output via transformer isolation; monophasic rectangular pulse waveform; 1-120Hz frequency; 75-300μs pulse width; 30V/60mA max output. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10. Microprocessor-controlled.

Indications for Use

Indicated for patients requiring pain relief, specifically for symptomatic relief of chronic intractable pain and adjunctive treatment of post-surgical and post-traumatic pain.

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

• Transcutaneous Electrical Nerve Stimulator (K202893)

Reference Devices

• Electrodes (K213879)

Submission Summary (Full Text)

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May 25, 2022

Bozhou Rongjian Medical Appliance Co., Ltd. Wu Zhifang General Manager Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, Anhui 233500 China

Re: K220578

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 18, 2022 Received: February 28, 2022

Dear Wu Zhifang:

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

Sincerely.

Amber Ballard, PhD 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

Enclosure

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# Indications for Use

510(k) Number (if known) K220578

Device Name

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

Indications for Use (Describe)

The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

Type of Use (Select one or both, as applicable)

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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

[As required by 21 CFR 807.92]

| 1. Submission Information | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K220578 |
| Date: | April 25, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| | Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou<br>City, 233500 Anhui, China |
| Contactor: | Wu Zhifang<br>E-mail: [e-mail]<br>Tel: [phone] |
| 2. Device Description | |
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) |
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is<br>an electrical nerve stimulator indicated for use for pain relief by<br>applying an electrical current to electrodes on a patient's skin to treat<br>pain. In particular, this device is indicated for use for symptomatic relief<br>of chronic intractable pain and adjunctive treatment in the management of<br>post surgical and post traumatic pain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends<br>gentle electrical current to underlying nerves and muscle group via<br>electrodes applied on the skin to relieve pain.<br>The device has 16 programs (12 standard programs and 4 editable<br>programs). It is a battery-powered portable device, comprising electronic<br>stimulatory module and accessories of lead wires, electrodes and 4×1.5V<br>AAA alkaline batteries.<br>Two outlet sockets are used to connect skin electrodes by lead wires. The<br>accessories of electrodes is 510(k) cleared device (K213879), Size<br>50*50mm. |

## 3. Predicate Device Identification

| Predicate 510(k) Number: | K202893 |
|---------------------------|--------------------------------------------|
| Marketing clearance date: | June 18, 2021 |
| Product name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |

## 4. Substantially Equivalent Comparison Conclusion

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| Parameters | New Device | Predicate Device | Comparison |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K220578 | K202893 | -- |
| Device Name | Transcutaneous Electrical<br>Nerve Stimulator (Model<br>RJTENS-1) | Transcutaneous Electrical<br>Nerve Stimulator | -- |
| Manufacturer | Bozhou Rongjian Medical<br>Appliance Co.,Ltd. | Wuxi Jiajian Medical<br>Instrument Co., Ltd | -- |
| Indication for Use | Transcutaneous Electrical Nerve<br>Stimulator ((Model RJTENS-1) is<br>an electrical nerve stimulator<br>indicated for use for pain relief<br>by applying an electrical<br>current to electrodes on a<br>patient's skin to treat pain. In<br>particular, this device is indicated<br>for use for symptomatic relief of<br>chronic intractable pain and<br>adjunctive treatment in the<br>management of post surgical and<br>post traumatic pain. | Transcutaneous Electrical<br>Nerve Stimulator is an electrical<br>nerve stimulator indicated for<br>use for pain relief by applying<br>an electrical current to<br>electrodes on a patient's skin to<br>treat pain. In particular, this<br>device is indicated for use for<br>symptomatic relief of chronic<br>intractable pain and adjunctive<br>treatment in the management of<br>post surgical and post traumatic<br>pain. | Same |
| Type of use | Prescription use | Prescription use | Same |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery | Same |
| - Method of Line<br>Current Isolation | N/A | N/A | Same |
| - Patient Leakage<br>Current | -- | -- | Same |
| - Normal<br>Condition (μΑ) | 2μΑ | 2μΑ | Same |
| - Single Fault<br>Condition (μΑ) | NA | NA | Same |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (μΑ) | <0.01μA | <0.01μA | Same |
| Number of program | 16 | 16 | Same |
| Number of Output<br>channels: | 2 | 2 | Same |
| - Synchronous<br>or Alternating? | Synchronous | Synchronous | Same |
| - Method of<br>Channel Isolation | By Transformer | By Transformer | Same |
| Regulated Current or<br>Regulated Voltage? | Current control | Current control | Same |
| Software/Firmware/ | Yes | Yes | Same |

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| Microprocessor<br>Control? | | | | | |
|----------------------------------------------|----------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-------------------|--|
| Automatic Overload<br>Trip? | No | No | Same | | |
| Automatic No-Load<br>Trip? | No | No | Same | | |
| Automatic Shut Off? | Yes | Yes | Same | | |
| User Override<br>Control? | Yes | Yes | Same | | |
| On/Off<br>Status? | Yes | Yes | Same | | |
| Indicat<br>or<br>Display | Low<br>Battery? | Yes | Yes | Same | |
| | Voltage/Current<br>Level? | Yes | Yes | Same | |
| | Timer Range<br>(minutes) | 10~90 min | 10~90 min | Same | |
| | Compliance with<br>Voluntary Standards? | ANSI AAMI ES60601-1, IEC<br>60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC<br>60601-1-2, IEC 60601-2-10 | Same | |
| | Compliance with 21<br>CFR 898? | Yes | Yes | Same | |
| | Weight (grams) | Approx.96g without battery | Approx.96g without battery | Same | |
| | Dimensions (mm) [W<br>x H x D] | 140*64*28 mm | 140*64*28 mm | Same | |
| | Housing Materials &<br>Construction | ABS | ABS | Same | |
| | Waveform | Monophasic | Monophasic | Same | |
| | Shape | Rectangular pulse | Rectangular pulse | Same | |
| | Maximum Output<br>Voltage (volts) | $30V±10% @500Ω$ | $30V±20% @500Ω$ | | |
| | Maximum Output<br>Current (specify<br>units) | $60mA±10% @500Ω$ | $60mA±20% @500Ω$ | Similar<br>Note 1 | |
| | Pulse width (μsec) | $75-300μs±10%$ | $75-300μs±20%$ | | |
| Pulse Period (msec) | | 8.33-1000ms | 8.33-1000ms | | |
| Max. pulse frequency<br>(Hz) [or Rate (pps)] | | $1-120Hz±10%$ | $1-120Hz±20%$ | | |
| | Net Charge (µC per<br>pulse) | $0.65μC @500Ω$ | $0.65μC @500Ω$ | | |
| Maximum Phase<br>Charge, (μC) | | $18μC @500Ω$ | $18μC @500Ω$ | Same | |
| Maximum Average<br>Current, (mA) | | $2.16mA @500Ω$ | $2.16mA @500Ω$ | | |

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| Density, (mA/cm², r.m.s.) | | | |
|-----------------------------------------------|-----------------------------|-----------------------------|------|
| Maximum Average<br>Power Density,<br>(mW/cm²) | 2.59mW/cm² @500Ω | 2.59mW/cm² @500Ω | |
| Accessories | Electrodes, cables, battery | Electrodes, cables, battery | Same |

Comparison in details:

### Note 1:

The deviation from the amplitude, frequency and pulse width of the proposed device are different from those of the predicate device. The proposed device has less deviation than the predicate device, which means that its output is more stable. And both the proposed device and predicate device passed ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 standards tests. Therefore, this difference will not raise any safety or effectiveness issue.

### 5. Non-Clinical Test Conclusion

Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:

• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD);

· IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;

· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;

### 6. Clinical Test

Clinical data was not including in this submission.

#### 7. Conclusions

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the subject device is substantially equivalent to the predicate device.