JKH Stimulator Plus

K182203 · Jkh USA, LLC · NUH · Mar 14, 2019 · Neurology

Device Facts

• Record ID: K182203
• Device Name: JKH Stimulator Plus
• Applicant: Jkh USA, LLC
• Product Code: NUH · Neurology
• Decision Date: Mar 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Over-The-Counter Use: TENS (Modes 1, 2, 4, 5, 6, 8): PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes. PMS (also called EMS, Modes 1, 3, 7): PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains. Prescription Use: PL-029K12 and PL-029K13 are intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Device Story

JKH Stimulator Plus (models PL-029K12, PL-029K13) is a TENS/PMS unit delivering electrical pulses to body areas via electrodes; includes heating function (PL-029K13) up to 43°C. Operated via device buttons or optional wireless/Bluetooth remote. Used in home or clinical settings by patients or clinicians. Inputs: user-selected intensity/mode; Outputs: electrical stimulation pulses and thermal heat. Affects clinical decision-making by providing non-pharmacological pain management, muscle conditioning, and circulation support. Benefits include temporary pain relief, improved muscle tone, and post-surgical recovery support.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, and ISO 10993-10. Software verification performed per FDA guidance.

Technological Characteristics

Transcutaneous electrical nerve/muscle stimulator; rechargeable/non-rechargeable battery powered. Features TENS, PMS, and heating modes. Max skin temp 43°C. Connectivity: wireless/Bluetooth remote. Biocompatible electrodes (patches, garments). Standards: IEC 60601-1, 60601-1-2, 60601-2-10, ISO 10993.

Indications for Use

Indicated for adults requiring temporary pain relief (TENS), muscle performance improvement/toning (PMS/EMS), or local blood circulation increase. Prescription use includes post-surgical/post-trauma pain, muscle spasm relaxation, disuse atrophy prevention, muscle re-education, range of motion maintenance, and venous thrombosis prevention. Heating mode (PL-029K13) for minor aches/pains.

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 (K162517)
• Sys*Stim ME 208 (K031017)
• ASCEND (K140333)
• Strive (K153704)

Submission Summary (Full Text)

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June 21, 2021

JKH USA, LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd, #861 Diamond Bar, California 91765

Re: K182203

Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, GZI, IPF

Dear Bill Quanqin Dai:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 14, 2019. Specifically, FDA is updating this SE Letter as an administrative correction. FDA has added a new product code, GZI, to better categorize your device technology to be consistent with your 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, OHT5: Office of Neurological and Physical Medicine Devices, by email (Amber.Ballard(@)fda.hhs.gov) or phone [phone]).

Sincerely,

Vivek J. Pinto -S

Vivek Pinto, PhD Division 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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March 14, 2019

JKH USA. LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765

Re: K182203

Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, IPF Dated: October 22, 2018 Received: January 2, 2019

Dear Bill Quanqin Dai:

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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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182203

Device Name JKH Stimulator Plus

Indications for Use (Describe) Over-The-Counter Use:

TENS (Modes 1, 2, 4, 5, 6, 8):

PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

PMS (also called EMS, Modes 1, 3, 7):

PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

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

X 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

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter's Information

Submitter: JKH USA, LLC Mailing Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Contact Person: Dr. Bill Quanqin Dai Tel: [phone] Email: Bill(@jkhUSA.com Date of Preparation: 06/29/2018

### 2. Subject Device

Trade/Device Name: JKH Stimulator Plus Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit. Powered Muscle Stimulation (PMS) unit, and heating for pain relief, blood circulation, and muscle performance Regulation Medical Specialtv: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, GZJ, GZI, IPF, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription

#### 3. Predicate device

Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd.

Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearance Date: May 30, 2003 Submitter: Mettler Electronics Corp.

Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date: July 3, 2014 Submitter: NeuroMetrix, Inc.

Predicate Device: Strive 510(k) Number: K153704 Clearance Date: June 3, 2016 Submitter: DJO, LLC

### 4. Description of Subject Device

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device

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has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains.

The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.

The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.

### 5. Indications for Use

Over-The-Counter Use:

TENS (Modes 1, 2, 4, 5, 6, 8):

PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

### PMS (also called EMS, Modes 1, 3, 7):

PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

#### Heating:

The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain

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- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

# 6. Summary of Substantial Equivalence

The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182203 | K162517 | K031017 | K140333 | K153704 |
| Submitter/<br>Manufacturer | JKH USA, LLC | JKH Health Co., Ltd. | Mettler Electronics<br>Corp. | NeuroMetrix, Inc. | DJO, LLC |
| Device Name/Model | PL-029K12 and<br>PL-029K13 | PL-029K12 and<br>PL-029K13 | Sys*Stim ME 208 | ASCEND | Strive |
| Intended Use | Over-The-Counter Use:<br><br>TENS (Modes 1, 2, 4, 5, 6,<br>8):<br>PL-029K12 and PL-<br>029K13 are used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, arm,<br>and leg, due to strain from<br>exercise or normal<br>household and work<br>activities.<br><br>PL-029K12 and PL-<br>029K13 are also intended<br>for symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis.<br><br>The device of PL-029K12<br>may be used during sleep.<br>The device of PL-029K12<br>is labeled for use only with<br>its own compatible<br>electrodes.<br><br>PMS (also called EMS,<br>Modes 1, 3, 7):<br>PL-029K12 and PL-<br>029K13 are used to<br>stimulate healthy muscles<br>in order to improve and<br>facilitate muscle<br>performance. To be used<br>for the improvement of | TENS:<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>arm, and leg, due to<br>strain from exercise or<br>normal household and<br>work activities.<br><br>It is also intended for<br>symptomatic relief and<br>management of<br>chronic, intractable<br>pain and relief of pain<br>associated with<br>arthritis.<br><br>PMS:<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>To be used for the<br>improvement of<br>muscle tone and<br>firmness, and for<br>strengthening muscles<br>in the arms, abdomen,<br>legs, and buttocks. Not<br>intended for use in any<br>therapy or for the<br>treatment of any<br>medical conditions or<br>diseases.<br><br>It is also intended to | 1. Symptomatic relief<br>of chronic intractable<br>pain, acute post<br>traumatic pain or<br>acute post-surgical<br>pain<br>2. Temporary relation<br>of muscle spasm<br>3. Prevention of<br>postsurgical phlebo-<br>thrombosis through<br>immediate<br>stimulation of calf<br>muscles<br>4. Increasing local<br>blood circulation<br>5. Prevention or<br>retardation of disuse<br>atrophy<br>6. Muscle re-<br>education<br>7. Maintaining or<br>increasing range of<br>motion | ASCEND is intended<br>for use as a<br>transcutaneous<br>electrical nerve<br>stimulation device for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the lower<br>extremities due to<br>strain from exercise<br>or normal household<br>and work activities.<br><br>ASCEND is intended<br>for use as a<br>transcutaneous<br>electrical nerve<br>stimulation device for<br>the symptomatic<br>relief and<br>management of<br>chronic intractable<br>pain.<br><br>The device may be<br>used during sleep.<br>The device is labeled<br>for use only with<br>compatible<br>NeuroMetrix<br>electrodes. | Prescription Use:<br>The StriveTM TENS<br>device is used for the<br>symptomatic relief<br>and management of<br>chronic, intractable<br>pain and relief of<br>pain associated with<br>arthritis. It is also<br>used as an adjunctive<br>treatment for post-<br>surgical and post-<br>trauma acute pain.<br><br>As a TENS device,<br>indications are for the<br>following conditions:<br>- Symptomatic relief<br>and management of<br>chronic, intractable<br>pain<br>- Adjunctive<br>treatment for post-<br>surgical and post-<br>trauma acute pain<br>- Relief of pain<br>associated with<br>arthritis<br><br>Over the Counter<br>Use:<br>The StriveTM TENS<br>device is used for:<br>-temporary relief of<br>pain associated with<br>sore and aching<br>muscles due to strain<br>from exercise or<br>normal household |
| | muscle tone and firmness,<br>and for strengthening<br>muscles in the arms,<br>abdomen, legs, and<br>buttocks. Not intended for<br>use in any therapy or for the<br>treatment of any medical<br>conditions or diseases.<br>PL-029K12 and PL-<br>029K13 are also intended to<br>temporarily increase local<br>blood circulation in the<br>healthy muscles of lower<br>extremities.<br>Heating:<br>The device of PL-029K13<br>is intended for temporary<br>relief of minor aches and<br>pains.<br>Prescription Use:<br>PL-029K12 and PL-<br>029K13 are intended for the<br>following use:<br>- Symptomatic relief and<br>management of chronic,<br>intractable pain<br>- Adjunctive treatment for<br>post-surgical and post-<br>trauma acute pain<br>- Relief of pain associated<br>with arthritis<br>- Temporary relaxation of<br>muscle spasm<br>- Prevention or retardation<br>of disuse atrophy<br>- Muscle re-education<br>- Maintaining or increasing<br>range of motion<br>- Increase of local blood<br>flow in the treatment area<br>- Prevention of post-<br>surgical venous thrombosis<br>through immediate<br>stimulation of calf muscles | temporarily increase<br>local blood circulation<br>in the healthy muscles<br>of lower extremities.<br>Heating:<br>Temporary relief of<br>minor aches and pains. | | | and work activities.<br>-the symptomatic<br>relief and<br>management of<br>chronic, intractable<br>pain and relief of<br>pain associated with<br>arthritis. |
| Prescription or OTC | OTC and Prescription | OTC | Prescription | OTC | OTC and Prescription |
| Power Source(s) | Rechargeable or non-<br>rechargeable battery | Rechargeable battery | Main (line) voltage | Rechargeable battery | Rechargeable battery |
| Compliance with<br>Voluntary Standards? | Yes | Yes | Yes | Yes | Yes |
| Compliance with 21<br>CFR 898? | Yes | Yes | Yes | Yes | Yes |
| Functions and design | Electrical stimulation and<br>heat | Electrical stimulation<br>and heat | Electrical stimulation | Electrical stimulation | Electrical stimulation |
| Maximum skin<br>temperature | 43 °C | 43 °C | N/A | N/A | N/A |
| Maximum output<br>voltage (Volts +/-<br>20%) at 500Ω | PL-029K12: 57.6<br>PL-029K13: 46.0 | PL-029K12: 57.6<br>PL-029K13: 46.0 | 92 | 50 | 30 |
| Maximum output<br>voltage (Volts +/- | PL-029K12: 96.0<br>PL-029K13: 90.4 | PL-029K12: 96.0<br>PL-029K13: 90.4 | 144 | 100 | 110 |
| 20%) at 2KΩ | | | | | |
| Maximum output voltage (Volts +/- 20%) at 10kΩ | PL-029K12: 134<br>PL-029K13: 124 | PL-029K12: 134<br>PL-029K13: 124 | 166 | 100 | 110 |
| Maximum output current (mA +/- 20%) at 500Ω | PL-029K12: 115.2<br>PL-029K13: 92.0…