JKH Stimulator Plus

K191151 · Jkh USA, LLC · NUH · Jun 21, 2019 · Neurology

Device Facts

• Record ID: K191151
• Device Name: JKH Stimulator Plus
• Applicant: Jkh USA, LLC
• Product Code: NUH · Neurology
• Decision Date: Jun 21, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Over-The-Counter Use: TENS: PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes. PMS: PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029T is intended for temporary relief of minor aches and pains. Prescription Use: TENS: PL-029K5BL, PL-029K15, and PL-029T 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 PMS: PL-029K5BL, PL-029K15, and PL-029T are intended for the following use: - 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 delivers electrical pulses to body areas (back, foot) via electrodes for TENS and PMS (EMS) therapy; also provides thermal heat (max 43°C). User operates via device buttons (ON/OFF, intensity) or optional wireless remote/Bluetooth app. Device features multiple program modes with varying pulse frequencies. Used in home or clinical settings by patients or clinicians. Output affects muscle performance, circulation, and pain management. Benefits include temporary pain relief, muscle strengthening, and improved circulation.

Clinical Evidence

Bench testing only. Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization) standards. No clinical data provided.

Technological Characteristics

Microprocessor-controlled TENS/PMS stimulator with heating. Housing: Silicone and ABS. Output: Biphasic waveform, voltage-regulated. Connectivity: Wireless/Bluetooth app optional. Power: Battery-operated. Safety: Automatic no-load trip and shut-off. Biocompatible electrodes (patches, garments).

Indications for Use

Indicated for temporary relief of pain (sore/aching muscles, chronic intractable pain, arthritis, post-surgical/post-trauma acute pain) and muscle stimulation (improve tone/firmness, strengthen muscles, relax spasms, prevent disuse atrophy, muscle re-education, maintain/increase range of motion, increase local blood flow, prevent post-surgical venous thrombosis). Used by adults for OTC or prescription applications.

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

• JKH Stimulator Plus (K182203)

Submission Summary (Full Text)

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June 21, 2019

Jkh Usa. LLC Bill Quanqin Dai, PhD Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765

Re: K191151

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, GZJ, IPF, IRT Dated: May 14, 2019 Received: May 23, 2019

Dear Dr. 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.

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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.

for Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191151

Device Name JKH Stimulator Plus

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

#### TENS:

PL-029K.5BL, PL-029K.15, and PL-029T 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-029K.5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K15 is labeled for use only with its own compatible electrodes.

PMS:

PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:

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

Prescription Use:

TENS:

PL-029K5BL, PL-029K15, and PL-029T 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

#### PMS:

PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:

- 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

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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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# K191151

## 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: [e-mail] Date of Preparation: 04/26/2019

## 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 Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, GZJ, IPF, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription

#### 3. Predicate device

Trade Name: JKH Stimulator Plus 510(k) Number: K182203 Clearance Date: March 14, 2019 Submitter: JKH USA, 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 elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device 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 biocompatible

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electrode patch/pad is withheld as the trade secret and may be disclosed as requested.

## 5. Indications for Use

Over-The-Counter Use:

#### TENS:

PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes.

#### PMS:

PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL. PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:

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

Prescription Use:

TENS:

PL-029K5BL, PL-029K15, and PL-029T 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

## PMS:

PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:

- 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

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substantially equivalent to those of the predicate device.

| Parameter & Predicate<br>Device(s) | Subject Device | Predicate Device | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 510(k) Number | K191151 | K182203 | |
| Submitter/Manufacturer | JKH USA, LLC | JKH USA, LLC | |
| Device Name/Model | JKH Stimulator Plus, PL-029K5BL, PL-<br>029K15, and PL-029T | JKH Stimulator Plus, PL-029K12 and PL-<br>029K13 | |
| Intended Use | Over-The-Counter Use:<br>TENS:<br>PL-029K5BL, PL-029K15, and PL-029T are<br>used for temporary relief of pain associated<br>with sore and aching muscles in the shoulder,<br>waist, back, arm, and leg, due to strain from<br>exercise or normal household and work<br>activities.<br>PL-029K5BL, PL-029K15, and PL-029T are<br>also intended for symptomatic relief and<br>management of chronic, intractable pain and<br>relief of pain associated with arthritis.<br>The device of PL-029K5BL and PL-029K15<br>may be used during sleep. The device of PL-<br>029K5BL and PL-029K15 is labeled for use<br>only with its own compatible electrodes.<br>PMS:<br>PL-029K5BL, PL-029K15, and PL-029T are<br>used to stimulate healthy muscles in order to<br>improve and facilitate muscle performance. To<br>be used for the improvement of muscle tone<br>and firmness, and for strengthening muscles in<br>the arms, abdomen, legs, and buttocks. Not<br>intended for use in any therapy or for the<br>treatment of any medical conditions or<br>diseases.<br>PL-029K5BL, PL-029K15, and PL-029T are<br>also intended to temporarily increase local<br>blood circulation in the healthy muscles of<br>lower extremities.<br>Heating:<br>The device of PL-029T is intended for<br>temporary relief of minor aches and pains.<br>Prescription Use:<br>TENS:<br>PL-029K5BL, PL-029K15, and PL-029T are<br>intended for the following use:<br>- Symptomatic relief and management of<br>chronic, intractable pain<br>- Adjunctive treatment for post-surgical and<br>post-trauma acute pain<br>- Relief of pain associated with arthritis<br>PMS:<br>PL-029K5BL PL-029K15 and PL-029T are | Over-The-Counter Use:<br>TENS:<br>PL-029K12 and PL-029K13 are used for<br>temporary relief of pain associated with sore<br>and aching muscles in the shoulder, waist, back,<br>arm, and leg, due to strain from exercise or<br>normal household and work activities.<br>PL-029K12 and PL-029K13 are also intended<br>for symptomatic relief and management of<br>chronic, intractable pain and relief of pain<br>associated with arthritis.<br>The device of PL-029K12 may be used during<br>sleep. The device of PL-029K12 is labeled for<br>use only with its own compatible electrodes.<br>PMS:<br>PL-029K12 and PL-029K13 are used to<br>stimulate healthy muscles in order to improve<br>and facilitate muscle performance. To be used<br>for the improvement of muscle tone and<br>firmness, and for strengthening muscles in the<br>arms, abdomen, legs, and buttocks. Not<br>intended for use in any therapy or for the<br>treatment of any medical conditions or diseases.<br>PL-029K12 and PL-029K13 are also intended<br>to temporarily increase local blood circulation<br>in the healthy muscles of lower extremities.<br>Heating:<br>The device of PL-029K13 is intended for<br>temporary relief of minor aches and pains.<br>Prescription Use:<br>PL-029K12 and PL-029K13 are intended for<br>the following use:<br>- Symptomatic relief and management of<br>chronic, intractable pain<br>- Adjunctive treatment for post-surgical and<br>post-trauma acute pain<br>- Relief of pain associated with arthritis<br>- Temporary relaxation of muscle spasm<br>- Prevention or retardation of disuse atrophy<br>- Muscle re-education<br>- Maintaining or increasing range of motion<br>- Increase of local blood flow in the treatment<br>area<br>- Prevention of post-surgical venous thrombosis<br>through immediate stimulation of calf muscles | |
| | | | |
| | | intended for the following use:<br>- Temporary relaxation of muscle spasm<br>- Prevention or retardation of disuse atrophy<br>- Muscle re-education<br>- Maintaining or increasing range of motion<br>- Increase of local blood flow in the treatment area<br>- Prevention of post-surgical venous<br>thrombosis through immediate stimulation of calf muscles | |
| Prescription or OTC | | OTC and Prescription | OTC and Prescription |
| Power Source(s) | | Rechargeable or non-rechargeable battery | Rechargeable or non-rechargeable battery |
| - Method of Line Current<br>Isolation | | Battery Supply | Battery Supply |
| - Patient Leakage Current:<br>Normal Condition (μΑ) | | N/A | N/A |
| - Patient Leakage Current: Single<br>Fault Condition (μΑ) | | N/A | N/A |
| Average DC current through<br>electrodes when device is on but<br>no pulses are being applied (mA) | | 0 | 0 |
| Number of Output Modes | | PL-029K5BL: 6-8<br>PL-029K15: 1-4<br>PL-029T: 8 | 8 |
| Number of Output | | 1-2 | 1 |
| -Synchronous/Alternating? | | N/A | N/A |
| -Method of Channel Isolation | | N/A | N/A |
| Regulated Current or Regulated<br>Voltage? | | Voltage…