TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

K230443 · Jiangxi Royall Smart Technology Co., Ltd. · NUH · May 22, 2023 · Neurology

Device Facts

• Record ID: K230443
• Device Name: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
• Applicant: Jiangxi Royall Smart Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04): - To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. - To stimulate healthy muscles in order to improve and facilitate muscle performance. - To temporarily increase local blood circulation in healthy muscles.

Device Story

TENS & EMS Device provides electrical pulse stimulation to treatment areas via electrode pads; intended for OTC pain management and muscle stimulation. Device features 1-3 channels (model dependent) and 3-5 stimulation modes. User operates device via ON/OFF knob, mode selection button, intensity dial/buttons, and time selection button. Device transforms electrical energy into pulsed, symmetric, biphasic waveforms; output parameters (frequency, intensity, pulse duration) are controlled by internal firmware. Healthcare providers or patients use device to manage chronic/intractable pain or muscle soreness; output affects nerve/muscle tissue to provide symptomatic relief, improve muscle performance, and increase local blood circulation. Benefits include non-pharmacological pain management and muscle conditioning.

Clinical Evidence

No clinical data. Bench testing only. Device performance validated via electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), biocompatibility (ISO 10993-1, -5, -10), and usability (IEC 62366-1, IEC 60601-1-6).

Technological Characteristics

Microprocessor-controlled TENS/EMS stimulator; DC 3.0V (2x AAA) power source. Delivers pulsed, symmetric, biphasic rectangular waveforms with interphase interval. Features 1 channel; intensity levels (5-15); frequency 1-136 Hz; pulse duration 200µs. Materials compliant with ISO 10993. Type BF applied part. Connectivity: None (standalone). Sterilization: Not specified.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in back, neck, upper/lower extremities due to exercise or household strain; symptomatic relief/management of chronic, intractable pain; relief of pain associated with arthritis; stimulation of healthy muscles to improve/facilitate performance; and temporary increase of local blood circulation in 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

• Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I (K163611)

Reference Devices

• Pain Therapy System, Model PTS-II (K150277)

Submission Summary (Full Text)

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May 22, 2023

Jiangxi Royall Smart Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong China

Re: K230443

Trade/Device Name: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: February 21, 2023 Received: February 21, 2023

Dear Cassie Lee:

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

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542 of the Act); 21 CFR 1000-1050.

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-

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,

# Robert Kang -S

for Pamela 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

Enclosure

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# Indications for Use

510(k) Number (if known) K230443

Device Name

TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)

Indications for Use (Describe)

TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):

- To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

- To temporarily increase local blood circulation in healthy muscles.

| 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 of K230443

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.

#### 1. Submitter's Information

Sponsor Name: Jiangxi Royall Smart Technology Co., Ltd. Establishment Registration Number: Applying Address: Workshop 3#, Shangyou Lefeng Technology Co., Ltd., Huangbu Town, Ganzhou City, Jiangxi Province Postal code: 341200 Contact Person (including title): Shunzhou Yang (Head of Quality Division) Tel: [phone] Fax: / E-mail: [e-mail]

#### Application Correspondent:

Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

#### 2. Date of the summary prepared: May 18, 2023

#### 3. Subject Device Information

Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Trade Name: TENS & EMS Device Model Name: LY-ET-01, LY-ET-02, LY-ET-04 510(K) Number: K230443 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Regulation Number: 882.5890 Regulatory Class: II

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#### 4. Predicate Device Information

Predicate Device: Sponsor: Guangzhou Xinbo Electronic Co., Ltd. Trade Name: Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K163611 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Requlation Number: 21 CRF 882.5890

Requlation Class: II

#### Reference device:

Sponsor: Counter Scientific Development (GZ) Ltd Trade/Device Name: Pain Therapy System, Model PTS-II Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K150277 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN GZJ Regulation Number: 21 CRF 882.5890 Regulatory Class: II

#### 5. Device Description

TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.

It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.

TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The

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TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.

The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.

#### 6. Intended Use / Indications for Use

TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):

- To be used for temporary relief of pain associated with sore and aching muscles in the upper and । lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance. -
- -To temporarily increase local blood circulation in healthy muscles.

#### 7. Comparison to predicate device and conclusion

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Reference device | Remark | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Jiangxi Royall Smart<br>Technology Co., Ltd. | Guangzhou Xinbo<br>Electronic Co., Ltd. | Counter Scientific<br>Development (GZ) Ltd | -- | |
| Trade Name | TENS & EMS Device | Pain Therapy Device, | Pain Therapy System | -- | |
| 510(k) Number | K230443 | K163611 | K150277 | -- | |
| Classification<br>Name | Transcutaneous<br>Electrical Nerve<br>Stimulator For Pain<br>Relief, Over The<br>Counter | Transcutaneous<br>Electrical Nerve<br>Stimulator For Pain<br>Relief, Over The<br>Counter | Transcutaneous<br>Electrical Nerve<br>Stimulator For Pain<br>Relief, Over The<br>Counter | Same | |
| Classification<br>Product Code | NUH | NUH | NUH | Same | |
| Subsequent<br>Product Code | NYN, NGX | NYN, NGX | GZJ, NGX, NYN | Same | |
| Elements of | | Subject Device | Predicate Device | Reference device | Remark |
| Comparison | | | | | |
| Intended Use /<br>Indications for Use | | TENS & EMS Device (<br>Model: LY-ET-01, LY-E<br>T-02, LY-ET-04):<br>- To be used for tempor<br>ary relief of pain associ<br>ated with sore and achi<br>ng muscles in the upper<br>and lower back, back o<br>f the neck, upper extre<br>mities (shoulder and ar<br>m), lower extremities (le<br>g and feet) due to strain<br>from exercise or norma<br>l household work activiti<br>es by applying current t<br>o stimulate nerve. To be<br>used for symptomatic r<br>elief and management o<br>f chronic, intractable pai<br>n and relief of pain asso<br>ciated with arthritis.<br>- To stimulate healthy m<br>uscles in order to impro<br>ve and facilitate muscle<br>performance .<br>- To temporarily increas<br>e local blood circulation<br>in healthy muscles. | To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the upper and lower<br>back, back of the neck,<br>upper extremities<br>(shoulder and arm),<br>lower extremities (leg<br>and feet) due to strain<br>from exercise or normal<br>household work<br>activities by applying<br>current to stimulate<br>nerve. To be used for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and<br>relief of pain associated<br>with arthritis (Choose<br>Mode B or C).<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance<br>(Choose Mode A).<br>To temporarily increase<br>local blood circulation in<br>healthy muscles<br>(Choose Mode A). | To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the upper and lower<br>back due to strain from<br>exercise or normal<br>household work<br>activities (Choose<br>Mode A, B, or C)<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the upper extremities<br>(Arms) due to strain<br>from exercise or normal<br>household work<br>activities (Choose<br>Mode A, B or C)<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the lower extremities<br>(Legs) due to strain<br>from exercise or normal<br>household work<br>activities (Choose<br>Mode A, B or C)<br>To be used for<br>symptomatic relief and<br>management of<br>chronic, intractable pain<br>and relief of pain<br>associated with Arthritis<br>(Choose Mode A)<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance<br>(Choose Mode B) | Same |
| Regulatory Class | | Class II | Class II | Class II | Same |
| OTC or Rx | | OTC | OTC | OTC | Same |
| Power Source(s) | | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | Same |
| Method of Line<br>Current Isolation | | Type BF Applied Part | Type BF Applied Part | Use resistance to<br>isolate | Same |
| Patient<br>Leakage<br>Current | NC<br>SFC | DC: <1 μA | DC: 0.5 μA | N/A | Similar<br>Note 1 |
| | | DC: <1 μA | DC: 0.6 μA | N/A | |
| Average DC | | < 0.01 μA | < 0.01 μA | 0 μA | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Reference device | Remark | |
| current through<br>electrodes when<br>device is on but no<br>pulses are being<br>applied | | | | | |
| Number of Output<br>Channels | 1 | 2 Channels: for models<br>P.T.S-II,<br>P.T.S-IIA, P.T.S-IIB;<br>1 Channel: for model<br>CP-I | 2 Synchronous | Similar<br>Note 2 | |
| Output Intensity<br>Level | LY-ET-01: 5 intensity<br>levels<br>LY-ET-02: 5 intensity<br>levels<br>LY-ET-04: 15 intensity<br>levels | 5 steps | Not published | Different<br>Note 2 | |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | Synchronous | Same | |
| Method of<br>Channel Isolation | Parallel connection | Parallel connection | Parallel connection | Same | |
| Software/Firmware<br>/Microprocessor<br>Control? | Yes | Yes | Yes | Same | |
| Automatic<br>Overload Trip | No | No…