StimPlus Patch, StimPlus Patch, StimPlus Patch
Device Facts
| Record ID | K200561 |
|---|---|
| Device Name | StimPlus Patch, StimPlus Patch, StimPlus Patch |
| Applicant | Jkh Health Co., Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | Jul 1, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
TENS: PL-029K29, PL-029K30, and PL-029Q 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-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone 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-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
Device Story
StimPlus Patch delivers electrical pulses to body areas via electrode patches/garments; provides TENS for pain relief, PMS for muscle performance/circulation, and optional heat. User operates via on-device buttons (ON/OFF, intensity adjustment) or optional wireless remote/Bluetooth app. Device transforms electrical energy into biphasic pulses; output intensity is user-controlled to achieve comfortable sensation. Used in home/OTC settings. Benefits include pain management, improved muscle tone, and increased local circulation. Healthcare providers do not operate; output is self-managed by patient.
Clinical Evidence
Bench testing only. Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, and ISO 10993-10. Software verification performed per FDA guidance.
Technological Characteristics
Materials: Silicone and ABS. Energy: Rechargeable or non-rechargeable battery. Output: Biphasic waveform, regulated voltage. Connectivity: Optional wireless/Bluetooth. Sterilization: Not specified. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10.
Indications for Use
Indicated for OTC use for temporary relief of pain in shoulder, waist, back, arm, and leg muscles due to strain; management of chronic, intractable pain; relief of arthritis pain; stimulation of healthy muscles to improve tone/strength in arms, abdomen, legs, and buttocks; and temporary increase of local blood circulation in healthy lower extremity muscles. Heating function indicated for temporary relief of minor aches and 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
Submission Summary (Full Text)
{0}------------------------------------------------
July 1, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
JKH Health Co., LTD Pu Jiang General Manager 4-5F, Building 12, Hengmingzhu Industral Park, Xinqiao Tongfuyu Industrial Area Shajing, Baoan Shenzhen, Guangdong 518104 China
Re: K200561
Trade/Device Name: StimPlus Patch 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 Dated: May 12, 2020 Received: June 3, 2020
Dear Pu Jiang:
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
{1}------------------------------------------------
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For:
Timothy Marjenin 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
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K200561
Device Name StimPlus Patch
# Indications for Use (Describe)
TENS:
PL-029K29, PL-029K30, and PL-029Q 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-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
#### PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone 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-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
#### 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 Health Co., Ltd. (Previous name: Shenzhen Jingkehui Electronic Co., Ltd.) Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xingiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Contact Person: Pu Jiang Tel: +86-755-27926589 Fax: +86-755-29970323 Email: Bill@JKHhealth.com Date of Preparation: 02/28/2020
## 2. Subject Device
Trade/Device Name: StimPlus Patch 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, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC)
## 3. Predicate device
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd.
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K141260 Clearance Date: September 17, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd.
## 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). the device may also provide heat 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/light 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.
{4}------------------------------------------------
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 (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.
## 5. Indications for Use
Over-The-Counter Use:
#### TENS:
PL-029K29, PL-029K30, and PL-029Q 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-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
## PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone 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-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
## 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.
| Parameter & Predicate<br>Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence | |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------|
| 510(k) Number | K200561 | K162517 | K141260 | N/A | |
| Submitter/Manufacturer | JKH Health Co., Ltd.<br>(Previous name: Shenzhen<br>Jingkehui Electronic Co.,<br>Ltd.) | JKH Health Co., Ltd. | Shenzhen Jingkehui<br>Electronic Co., Ltd. | Identical | |
| Device Name/Model | PL-029K29, PL-029K30,<br>and PL-029Q | PL-029K12 and PL-029K13 | PL-029K | N/A | |
| Intended Use | TENS:<br>PL-029K29, PL-029K30,<br>and PL-029Q 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>PL-029K29, PL-029K30,<br>and PL-029Q are also<br>intended for symptomatic<br>relief and management of<br>chronic, intractable pain and<br>relief of pain associated with<br>arthritis.<br>PMS:<br>PL-029K29, PL-029K30,<br>and PL-029Q are used to<br>stimulate healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance. To be used for<br>the improvement of muscle<br>tone and firmness, and for<br>strengthening muscles in the<br>arms, 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-029K29, PL-029K30,<br>and PL-029Q are also<br>intended to temporarily<br>increase local blood<br>circulation in the healthy<br>muscles of lower extremities.<br>Heating:<br>PL-029K30 and PL-029Q is<br>intended for temporary relief<br>of minor aches and pains. | TENS:<br>PL-029K12 and PL-029K13<br>are used for temporary relief<br>of pain associated with sore<br>and 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>PL-029K12 and PL-029K13<br>are also intended for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief of<br>pain associated with arthritis.<br>PMS:<br>PL-029K12 and PL-029K13<br>are used to stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance. To be used for<br>the improvement of muscle<br>tone and firmness, and for<br>strengthening muscles in the<br>arms, 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-029K13<br>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 is<br>intended for temporary relief<br>of minor aches and pains. | To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>arm, and leg, due to strain<br>from exercise or normal<br>household and work<br>activities. | Identical | |
| Prescription or OTC | OTC | OTC | OTC | Identical | |
| Power Source(s) | Rechargeable or non-<br>rechargeable battery | Rechargeable battery | Non-rechargeable battery | Identical | |
| - Method of Line Current<br>Isolation | Battery Supply | Battery Supply | Battery Supply | Identical | |
| - Patient Leakage Current:<br>Normal Condition (μΑ) | 2.0 | 2.0 | 2.0 | Identical | |
| - Patient Leakage Current:<br>Single Fault Condition<br>(μΑ) | <10.0 | <10.0 | <10.0 | Identical | |
| Average DC current<br>through electrodes when<br>device is on but no pulses<br>are being applied (mA) | 0 | 0 | 0 | Identical | |
| | Number of Output Modes | PL-029K29: 1-8<br>PL-029K30: 1-8<br>PL-029Q: 1-8 | 8 | 8 | The program modes of the<br>subject device are from<br>those of the predicate<br>device. |
| | Number of Output | 1-2 | 1 | 1 | Identical |
| | Synchronous/Alternating? | PL-029K29: Synchronous<br>PL-029K30: Synchronous<br>PL-029Q: Synchronous | Synchronous | Synchronous | Identical |
| | -Method of Channel<br>Isolation | 1 | 1 | 1 | Identical |
| | Regulated Current or<br>Regulated Voltage? | Voltage | Voltage | Voltage | Identical |
| | Software/Firmware/<br>Microprocessor Control? | Yes | Yes | Yes | Identical |
| | Automatic Overload Trip? | No | No | No | Identical |
| | Automatic No-Load Trip? | Yes | Yes | No | Identical |
| | Automatic Shut Off? | Yes | Yes | Yes | Identical |
| | User Override Control? | Yes | Yes | Yes | Identical |
| Indicator | On/Off | Yes | Yes | Yes | Identical |
| Display: | Low Battery? | Yes | Yes | No | Identical |
| | Voltage/<br>Current<br>Level? | No | No | No | Identical |
| | Timer Range (minutes) | PL-029K29: 10~60<br>PL-029K30: 10~60<br>PL-029Q: 10~60 | PL-029K12: 10~540<br>PL-029K13: 10~540 | 15~60 | Identical |
|…
