(360 days)
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 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.
The provided document is a 510(k) Premarket Notification from the FDA for a device called "Medi-Direct TENS Pen." This document is primarily concerned with demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies that would be typical for more complex medical devices, especially those involving AI or nuanced diagnostic capabilities.
Therefore, the information requested about acceptance criteria, detailed study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) is not present in this document. This typically applies to devices that rely on complex algorithms, imaging analysis, or diagnostic accuracy, which is not the case for this TENS device.
Instead, the document details a comparison of technical specifications to predicate devices and adherence to voluntary electrical safety and electromagnetic compatibility standards.
Here's what can be extracted and inferred from the document regarding "acceptance" for this specific type of device, based on the principle of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
For this type of device, "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) against a clinical outcome. Instead, they are framed as meeting safety standards and having comparable technical characteristics and intended use to existing, cleared devices. The "reported device performance" is essentially the device's technical specifications and its compliance with standards.
| Acceptance Criteria (Proxy for Substantial Equivalence) | Reported Device Characteristics / Performance |
|---|---|
| Intended Use Equivalence: Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. | Fully matches the Intended Use of the predicate devices (K162517, K141260, K133789) as detailed in the "Indications for Use" section and Table 1. |
| Technical Characteristic Equivalence (Key Parameters comparable to predicates): | As summarized in Table 1, the subject device's parameters (e.g., maximum output voltage & current, pulse duration, frequency, maximum phase charge, maximum current density, maximum average power density) are within the ranges or comparable to those of the predicate devices. |
| Safety Standard Compliance: | Complies with IEC 60601-1 (General electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-10 (Specific for nerve and muscle stimulators). |
| Power Source: Battery-powered. | Confirmed as "Battery" and "Battery Supply" for line current isolation. |
| Waveform & Shape: Monophasic, Rectangular. | Stated for the subject device. |
| Output Type: Voltage regulated. | Stated for the subject device. |
| No new safety or effectiveness issues. | Stated explicitly as a conclusion of the comparison: "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." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document refers to non-clinical testing for electrical safety and electromagnetic compatibility, not a clinical "test set" in the sense of patient data for performance evaluation.
- Data Provenance: Not applicable for patient data. The non-clinical tests were performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. Ground truth as typically understood (e.g., expert radiological reads, pathological confirmation) is not relevant for this device's premarket notification, which focuses on engineering specifications and safety compliance.
4. Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) Pen, a physical therapy device for pain relief. It does not involve AI, image reading, or human interpretation that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm in the sense of a diagnostic or interpretative AI is involved. The device's "performance" is its electrical output and safety compliance.
7. The Type of Ground Truth Used:
- For this device, "ground truth" equates to engineering specifications, compliance with international voluntary standards (IEC 60601 series), and a comparison to the known, cleared characteristics of existing predicate devices. There is no clinical "ground truth" derived from patient outcomes or expert diagnoses mentioned.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI model or complex algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
Summary of the Study Proving Acceptance for this Specific Device:
The "study" proving the device meets "acceptance criteria" (defined as substantial equivalence) is primarily non-clinical testing and a detailed comparison to established predicate devices.
-
Non-Clinical Tests Performed (Section 8):
- Validation of design and assurance of conformance with voluntary standards.
- Standards Covered:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic Compatibility (EMC) requirements and tests.
- IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- The document states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence."
-
Substantial Equivalence Comparison (Section 6, Table 1):
- A direct comparison of the "Medi-Direct TENS Pen" (subject device) to three predicate devices (K162517, K141260, K133789) across numerous parameters.
- Key Parameters Compared: Intended Use, Prescription/OTC status, Power Source, Electrical Characteristics (leakage current, output channels, regulated current/voltage, waveform, shape, maximum output voltage/current, pulse duration, frequency, maximum phase charge, current density, power density), Software/Firmware, Safety Features (Overload/No-Load Trip, Automatic Shut-Off), User Controls, Indicators, Compliance with Standards, and Housing Materials.
- Conclusion of Comparison: The document explicitly states: "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 effectiveness." And ultimately, "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."
In conclusion, for the Medi-Direct TENS Pen, "acceptance" for FDA clearance was demonstrated through engineering and electrical compliance testing against consensus standards and a feature-by-feature comparison to already cleared similar devices, rather than a clinical study evaluating diagnostic or treatment efficacy.
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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
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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
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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)
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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: 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
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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 & PredicateDevice(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 JingkehuiElectronic 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 temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, arm, and leg,due to strain fromexercise or normalhousehold and workactivities. | TENS:To be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,arm, and leg, due tostrain from exercise ornormal household andwork activities.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain andrelief of pain associatedwith arthritis. | To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, arm, and leg,due to strain fromexercise or normalhousehold and workactivities. | The DolphinNeurostim™ OT C isindicated for temporaryrelief of pain associatedwith sore and achingmuscles in the back,arms, and legs due tostrain from exercise ornormal household andwork activities. |
| Prescription or OTC | OTC | OTC | OTC | OTC |
| Power Source(s) | Battery | Rechargeable battery | Battery | Battery |
| - Method of Line CurrentIsolation | 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 throughelectrodes when device is onbut 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
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| Regulated Current or RegulatedVoltage? | 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 | |
| IndicatorDisplay: | On/Off Status? | No | Yes | Yes | Yes |
| Low Battery? | No | Yes | No | Yes | |
| Voltage/CurrentLevel? | No | Yes | No | No | |
| Timer Range (minutes) | No | 10~540 | 15~60 | No | |
| Compliance with VoluntaryStandards? | Yes | Yes | Yes | Yes | |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Yes | |
| Housing Materials andConstruction | 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) at500Ω | 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 powerdensity (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.
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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.
§ 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).