(119 days)
Not Found
No
The summary describes a standard TENS/PMS device with manual controls and optional wireless control. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as providing temporary relief of pain associated with sore and aching muscles, symptomatic relief and management of chronic pain, and relief of pain associated with arthritis, which are therapeutic claims. It also mentions improving and facilitating muscle performance, strengthening muscles, and increasing local blood circulation, which can also be considered therapeutic.
No
The device is described as providing temporary relief of pain, stimulating muscles, and increasing blood circulation, which are therapeutic functions, not diagnostic ones. Diagnostics involve identifying or investigating a disease or condition.
No
The device description explicitly states it delivers electric pulses through electrodes and includes physical operating elements like buttons. It also mentions providing heat. While it has optional wireless control via a remote or Bluetooth APP, the core functionality involves hardware components that deliver the therapy.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended uses described (pain relief, muscle stimulation, temporary increase in blood circulation, temporary relief of minor aches and pains) are all related to in vivo applications, meaning they are applied to and affect the living body directly.
- Device Description: The device delivers electric pulses to the user's body through electrodes. This is a physical interaction with the body, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
In Vitro Diagnostics (IVDs) are medical devices intended to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a therapeutic device that applies electrical stimulation and potentially heat to the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, NYN, IRT
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, and leg, arms, abdomen, legs, and buttocks, lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter (OTC)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
- (d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
- (e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
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) |
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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
| Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence | |
|---|---|---|---|---|---|
| 510(k) Number | K200561 | K162517 | K141260 | N/A | |
| Submitter/Manufacturer | JKH Health Co., Ltd. | ||||
| (Previous name: Shenzhen | |||||
| Jingkehui Electronic Co., | |||||
| Ltd.) | JKH Health Co., Ltd. | Shenzhen Jingkehui | |||
| Electronic Co., Ltd. | Identical | ||||
| Device Name/Model | PL-029K29, PL-029K30, | ||||
| and PL-029Q | PL-029K12 and PL-029K13 | PL-029K | N/A | ||
| Intended 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 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-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. | TENS: | ||||
| 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. | |||||
| PMS: | |||||
| 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. | To be 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. | Identical | ||||
| Prescription or OTC | OTC | OTC | OTC | Identical | |
| Power Source(s) | Rechargeable or non- | ||||
| rechargeable battery | Rechargeable battery | Non-rechargeable battery | Identical | ||
| - Method of Line Current | |||||
| Isolation | Battery Supply | Battery Supply | Battery Supply | Identical | |
| - Patient Leakage Current: | |||||
| Normal Condition (μΑ) | 2.0 | 2.0 | 2.0 | Identical | |
| - Patient Leakage Current: | |||||
| Single Fault Condition | |||||
| (μΑ) |