(360 days)
Not Found
No
The device description explicitly states it has a single mode, a single button, and delivers a fixed stimulation output. There is no mention of adaptive behavior, learning, or any components typically associated with AI/ML. The performance studies focus on electrical safety and electromagnetic compatibility, not algorithmic performance.
Yes
The device is described as providing "temporary relief of pain" by activating nerves and/or muscles, which are therapeutic actions.
No.
The device is described as a TENS unit used for temporary pain relief by delivering electrical pulses, not for diagnosing medical conditions.
No
The device description explicitly states it is a "hand-held and battery-powered unit of TENS" and describes physical components like a metal contact tip and grounding contact, indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly states that this device is a hand-held TENS unit used for the temporary relief of pain associated with sore and aching muscles. It delivers electrical stimulation directly to the user's skin.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the user. The device interacts directly with the body's surface.
Therefore, based on the provided description, this device falls under the category of a therapeutic device, specifically a TENS unit, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The subject device is a hand-held and battery-powered unit of TENS. It combines the electrical characteristics of TENS with the point stimulation delivered through the electrodes of a metal contact tip and a metal grounding contact on the device has only one TENS mode of the low frequency (2 Hz), and only one button (Power Button). When the Power Button is held down, the device will turn on and deliver the fixed stimulation output to the user's body skin; when the Power Button is released, the device will turn off and the stimulation output will stop. Therefore, the device is very simple and easy to use. The device is designed to generate small pulses of electrical current and delivers the pulses to the user's skin through the metal contact tip such that the underlying nerves and/or muscles are activated for pain relief.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. 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) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
(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".
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
September 21, 2019
JKH USA, LLC Bill Dai Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765
Re: K182671
Trade/Device Name: Medi-Direct TENS Pen Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: June 6, 2019 Received: August 23, 2019
Dear Bill 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 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
1
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,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182671
Device Name Medi-Direct TENS Pen
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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 USA, LLC Mailing Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Contact Person: Bill Quanqin Dai Tel: 909-929-9896 Email: Bill@jkhUSA.com Date of Preparation: 06/29/2018
2. Subject Device
Trade/Device Name: Medi-Direct TENS Pen Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH 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, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd.
Predicate Device: Dolphin Neurostim OTC 510(k) Number: K133789 Clearance Date: March 4, 2015 Submitter: Acumed Medical, Ltd.
4. Description of Subject Device
The subject device is a hand-held and battery-powered unit of TENS. It combines the electrical characteristics of TENS with the point stimulation delivered through the electrodes of a metal contact tip and a metal grounding contact on the device has only one TENS mode of the low frequency (2 Hz), and only one button (Power Button). When the Power Button is held down, the device will turn on and deliver the fixed stimulation output to the user's body skin; when the Power Button is released, the device will turn off and the stimulation output will stop. Therefore, the device is very simple and easy to use.
The device is designed to generate small pulses of electrical current and delivers the pulses to the user's
4
skin through the metal contact tip such that the underlying nerves and/or muscles are activated for pain relief.
5. Indications for Use
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.
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 | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| 510(k) Number | K182671 | K162517 | K141260 | K133789 |
| Submitter/Manufacturer | JKH USA, LLC | JKH Health Co., Ltd. | Shenzhen Jingkehui | |
| Electronic Co., Ltd. | Acumed Medical, Ltd. | |||
| Device Name/Model | Medi-Direct TENS Pen | PL-029K12 | PL-029K | Dolphin Neurostim OTC |
| Intended Use | 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. | TENS: | |||
| 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. | ||||
| It is also intended for | ||||
| symptomatic relief and | ||||
| management of chronic, | ||||
| intractable pain and | ||||
| relief of pain associated | ||||
| with arthritis. | 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. | The Dolphin | |||
| Neurostim™ OT C is | ||||
| indicated for temporary | ||||
| relief of pain associated | ||||
| with sore and aching | ||||
| muscles in the back, | ||||
| arms, and legs due to | ||||
| strain from exercise or | ||||
| normal household and | ||||
| work activities. | ||||
| Prescription or OTC | OTC | OTC | OTC | OTC |
| Power Source(s) | Battery | Rechargeable battery | Battery | Battery |
| - Method of Line Current | ||||
| Isolation | Battery Supply | Battery Supply | Battery Supply | Battery Supply |
| - Patient Leakage Current: | ||||
| Normal Condition (uA) | N/A | N/A | N/A | N/A |
| - Patient Leakage Current: | ||||
| Single Fault Condition (μΑ) | N/A | N/A | N/A | N/A |
| Average DC current through | ||||
| electrodes when device is on | ||||
| but no pulses are being applied | ||||
| (mA) | 0 | 0 | 0 | 0 |
| Number of Output | 1 | 1 | 1 | 1 |
| -Synchronous/Alternating? | N/A | N/A | N/A | N/A |
| -Method of Channel Isolation | N/A | N/A | N/A | N/A |
Table 1. Comparison between the subject device and the predicate device
5
| Regulated Current or Regulated
| Voltage? | Voltage | Voltage | Voltage | Voltage | |
|---|---|---|---|---|---|
| Software/Firmware/ | |||||
| Microprocessor Control? | Yes | Yes | Yes | Yes | |
| Automatic Overload Trip? | No | No | No | No | |
| Automatic No-Load Trip? | No | Yes | No | No | |
| Automatic Shut Off? | No | Yes | Yes | No | |
| User Override Control? | Yes | Yes | Yes | Yes | |
| Indicator | |||||
| Display: | On/Off Status? | No | Yes | Yes | Yes |
| Low Battery? | No | Yes | No | Yes | |
| Voltage/Current | |||||
| Level? | No | Yes | No | No | |
| Timer Range (minutes) | No | 10~540 | 15~60 | No | |
| Compliance with Voluntary | |||||
| Standards? | Yes | Yes | Yes | Yes | |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Yes | |
| Housing Materials and | |||||
| Construction | ABS plastic & metal | ABS, metal, & Silicone | ABS & Silicone | ABS plastic & metal | |
| Waveform | Monophasic | Biphasic | Monophasic | Monophasic & Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum output voltage | |||||
| (Volts +/- 20%) at 500Ω | 7.1 | 24~57.6 | 37.2~71.2 | 1 | |
| Maximum output voltage | |||||
| (Volts +/- 20%) at 2KΩ | 27.6 | 53.6~96 | 64.8~122 | 3 | |
| Maximum output voltage | |||||
| (Volts +/- 20%) at 10kΩ | 132 | 105~134 | 96.8~146 | 6.6 | |
| Maximum output current (mA | |||||
| +/- 20%) at 500Ω | 14.2 | 48~115.2 | 74.4~142.4 | 2 | |
| Maximum output current (mA | |||||
| +/- 20%) at 2KΩ | 13.8 | 26.8~48 | 32.4~61 | 1.5 | |
| Maximum output current (mA | |||||
| +/- 20%) at 10KΩ | 13.2 | 10.5~13.4 | 9.7~14.6 | 0.7 | |
| Pulse duration (µSec) | 106 | 100 | 50~100 | 213000 | |
| Frequency (Hz) | 2 | 1.2~156 | 1.2~83.3 | 2.4-3.0 | |
| Maximum Phase charge (µC) at | |||||
| 500Ω | 1.51 | 9.6~23 | 3.7~33 | 440 | |
| Maximum current density | |||||
| (mA/cm²) at 500Ω | 203 | 1.64~3.26 | 4.65~8.9 | 210 | |
| Maximum average power | |||||
| density (W/cm²) at 500Ω | 0.00031 | 0.00004~0.00144 | 0.00012~0.0031 | 0.116 |
As shown in the above comparison table, the maximum output voltage and current of the subject device are within those ranges of the predicate device; the pulse duration, period, frequency, maximum phase charge, and maximum current density of the subject device are smaller or almost the same as those of the predicate device; the maximum average power density of the subject device is within the range of
the predicate device. Therefore, the differences do not affect safety or
As demonstrated above, the differences do not affect the intended use or alter th mental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results to the predicate device.
6
8. Non-Clinical Tests Performed
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. 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) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (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".
9. Conclusion
The tests performed and the comparison of technical characteristics and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.