(217 days)
TENS (Modes 1, 2, 4, 5, 6, 8)
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.
PMS (also called EMS, Modes 1, 3, 7)
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.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating Mode Temporary relief of minor aches and pains.
Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. 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 °C.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature 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 pads and electrode garments, which could be packaged separately and/or together with the subject device.
This document is a 510(k) summary for an Electronic Pulse Stimulator (device K162517). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices (K153520 and K070299). Since this is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) device, the acceptance criteria and study information will focus on its electrical and heating parameters rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a predetermined numerical threshold for a clinical outcome (e.g., "sensitivity must be >90%"). Instead, it demonstrates "substantial equivalence" based on various technical specifications and intended use. The "reported device performance" is essentially a comparison of these technical specifications between the subject device and the predicate devices.
The table below summarizes the comparison from Table 1 in the document for the subject device (PL-029K13, as it includes the heating mode) and its primary predicate (PL-029K6, K153520) for electrical stimulation, and the heating predicate (ezFit Digital Heating TENS, K070299) for the heating function. The ranges and specific values are presented as performance data.
| Feature | Predicate Device (K153520) Performance (PL-029K6) | Predicate Device (K070299) Performance (ezFit Digital Heating TENS) | Subject Device (K162517) Performance (PL-029K13) | Acceptance Criteria/Basis for Equivalence |
|---|---|---|---|---|
| TENS Mode | ||||
| Intended Use (TENS) | Temporary relief of pain (sore/aching muscles, chronic intractable pain, arthritis) | Symptomatic relief and management of chronic intractable pain. | Temporary relief of pain (sore/aching muscles, chronic intractable pain, arthritis) | Substantially Equivalent to K153520 for TENS. |
| Max Output Voltage (500Ω) | Mode 2: 39.2; Mode 3: 64; Mode 4: 56.8; Mode 5: 33.2; Mode 6: 31.6 | Undisclosed | Mode 2: 31.2; Mode 3: 46.0; Mode 4: 42.0; Mode 5: 27.6; Mode 6: 27.6; Mode 7: 40.8; Mode 8: 23.2 | Similar technical characteristics topredicate. The 7th and 8th modes of the subject device are similar to the 6 initial modes of the predicate. |
| Max Output Voltage (2kΩ) | Mode 2: 82.4; Mode 3: 84; Mode 4: 79.2; Mode 5: 70.4; Mode 6: 67.2 | Undisclosed | Mode 2: 68.0; Mode 3: 90.4; Mode 4: 68.8; Mode 5: 60.0; Mode 6: 60.0; Mode 7: 84.0; Mode 8: 50.4 | Similar technical characteristics topredicate. |
| Max Output Voltage (10kΩ) | Mode 2: 129; Mode 3: 120; Mode 4: 84.8; Mode 5: 121; Mode 6: 124 | Undisclosed | Mode 2: 118; Mode 3: 124; Mode 4: 78.4; Mode 5: 115; Mode 6: 115; Mode 7: 124; Mode 8: 99.2 | Similar technical characteristics topredicate. |
| Max Output Current (500Ω) | Mode 2: 78.4; Mode 3: 128; Mode 4: 113.6; Mode 5: 64.4; Mode 6: 63.2 | Undisclosed | Mode 2: 62.4; Mode 3: 92.0; Mode 4: 84.0; Mode 5: 55.2; Mode 6: 55.2; Mode 7: 81.6; Mode 8: 46.4 | Similar technical characteristics topredicate. |
| Max Output Current (2kΩ) | Mode 2: 41.2; Mode 3: 42; Mode 4: 39.6; Mode 5: 35.2; Mode 6: 33.6 | Undisclosed | Mode 2: 34.0; Mode 3: 45.2; Mode 4: 34.4; Mode 5: 30.0; Mode 6: 30.0; Mode 7: 42.0; Mode 8: 25.2 | Similar technical characteristics topredicate. |
| Max Output Current (10kΩ) | Mode 2: 12.9; Mode 3: 12; Mode 4: 8.5; Mode 5: 12.1; Mode 6: 12.4 | Undisclosed | Mode 2: 11.8; Mode 3: 12.4; Mode 4: 7.84; Mode 5: 11.5; Mode 6: 11.5; Mode 7: 12.4; Mode 8: 9.92 | Similar technical characteristics topredicate. |
| Pulse Period (mSec) | 10-833 | Undisclosed | 5.6-806 | Similar technical characteristics topredicate. |
| Frequency (Hz) | Mode 2: 69.4; Mode 3: 13.0-52.1; Mode 4: 1.2; Mode 5: 96.2; Mode 6: 96.2 | Undisclosed | Mode 2: 73.5; Mode 3: 13.7-59.5; Mode 4: 1.24; Mode 5: 104.1; Mode 6: 104.1; Mode 7: 20.8; Mode 8: 178.5 | Similar technical characteristics topredicate. |
| Max Phase Charge (500Ω) | Mode 2: 15.1; Mode 3: 25.6; Mode 4: 18.2; Mode 5: 12.8; Mode 6: 10.1 | Undisclosed | Mode 2: 11.5; Mode 3: 16.9; Mode 4: 15.5; Mode 5: 10.2; Mode 6: 10.2; Mode 7: 15.0; Mode 8: 8.54 | Similar technical characteristics topredicate. |
| Max Current Density (500Ω) | Mode 2: 2.18; Mode 3: 3.56; Mode 4: 3.16; Mode 5: 1.84; Mode 6: 1.76 | Undisclosed | Mode 2: 2.23; Mode 3: 3.29; Mode 4: 3.00; Mode 5: 1.97; Mode 6: 1.97; Mode 7: 2.91; Mode 8: 1.66 | Similar technical characteristics topredicate. |
| Max Average Power Density (500Ω) | Mode 4: 0.03; Mode 2: 1.14; Mode 3: 0.64-2.56; Mode 5: 1.13; Mode 6: 0.85 | Undisclosed | Mode 2: 0.92; Mode 3: 0.32-1.37; Mode 4: 0.04; Mode 5: 1.04; Mode 6: 1.04; Mode 7: 0.46; Mode 8: 1.26 | Similar technical characteristics topredicate. |
| PMS Mode | ||||
| Intended Use (PMS) | Stimulate healthy muscles (improve/facilitate muscle performance, muscle tone/firmness, strengthening, increase local blood circulation) | Not applicable (K070299 only TENS and heating) | Stimulate healthy muscles (improve/facilitate muscle performance, muscle tone/firmness, strengthening, increase local blood circulation) | Substantially Equivalent to K153520 for PMS. |
| Heating Mode | ||||
| Intended Use (Heating) | Not applicable (K153520 only TENS and PMS) | Temporary relief of minor aches and pains and muscle spasms. | Temporary relief of minor aches and pains. | Substantially Equivalent to K070299. The technology is similar, and the indications are comparable. |
| Heating Setting | N/A | Adjustable (36-42 °C) | Low and High | Similar technology (delivery of heat). |
| Maximum Temperature Setting | N/A | 42 °C | 43 °C | Similar maximum temperature setting, within acceptable safety margins for human skin. |
| Skin Temperature | N/A | N/A (implied safe operation across range) | Reached 41 °C in 20 min and remained stable. | Demonstrates safe temperature limits and stable operation. |
| Prescription/OTC | OTC | Prescription | OTC | Transition from prescription to OTC for heating is supported by substantial equivalence in technology and safety. The electrical stimulation aspects are OTC as well (similar to K153520). |
For non-clinical tests, the "acceptance criteria" were compliance with specific voluntary standards:
- IEC 60601-1 (medical electrical equipment safety and essential performance)
- IEC 60601-1-2 (electromagnetic compatibility)
- IEC 60601-2-10 (particular requirements for nerve and muscle stimulators)
- FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.
The reported device performance for these non-clinical tests is that the device "conformed" and "met the requirement of safety" for the standards and guidance, respectively.
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device..."
Therefore, there is no clinical test set, human subject data, or data provenance (country of origin, retrospective/prospective) described in this 510(k) summary for the purpose of demonstrating substantial equivalence. The evaluation relies on technical comparisons to predicate devices and adherence to engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As no clinical test set was used, there was no ground truth established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would be the specifications and requirements of the regulatory standards themselves, which are established by expert committees in their respective fields (e.g., electrical engineering, medical device safety).
4. Adjudication Method for the Test Set
Since no clinical test set with human subject outcomes was used for demonstrating substantial equivalence, no adjudication method (like 2+1 or 3+1 consensus) was applied.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which is not applicable to an Electronic Pulse Stimulator submission focused on electrical and heating parameters and substantial equivalence to existing devices.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone performance study in the context of an AI/ML algorithm was not done. The "performance" in this submission refers to the technical specifications of the device (e.g., output voltage, current, temperature) and its compliance with safety standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the technical specifications, the "ground truth" is established by engineering measurements against reference standards (e.g., voltmeters, ammeters, thermometers calibrated to international standards) to verify the device's output. For compliance with voluntary standards (IEC 60601-1, -1-2, -2-10), the "ground truth" is the requirements outlined in those international standards. For software, it's compliance with FDA guidance for software in medical devices.
8. The Sample Size for the Training Set
Since this is not an AI/ML device, there is no training set sample size described. The device's operation is based on fixed electrical circuits and heating elements, not learned models.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
JKH Health Co., Ltd. % Bill Quangin Dai 1142 S. Diamond Bar Blvd. #861 Diamond Bar, CA 91765
Re: K162517
Trade/Device Name: Electronic Pulse Stimulator 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: March 14, 2017 Received: March 21, 2017
Dear Dr. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Carlos L. Pena -S) A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162517
Device Name Electronic Pulse Stimulator
Indications for Use (Describe)
TENS (Modes 1, 2, 4, 5, 6, 8)
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.
PMS (also called EMS, Modes 1, 3, 7)
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.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating Mode 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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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, Xinqiao 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: 08/30/2016
2. Subiect Device
Trade/Device Name: Electronic Pulse Stimulator Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit and Powered Muscle Stimulation (PMS) unit 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: K153520 Clearance Date: Mav 05, 2016 Submitter: JKH Health Co., Ltd. (Previous name: Shenzhen Jingkehui Electronic Co., Ltd.)
Predicate Device: ezFit Digital Heating TENS Clearance Date: July 16, 2007 510(k) Number: K070299 Submitter: ezFit Technology, Inc.
4. Description of Subject Device
Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. 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 °C.
The device could be easily operated through its buttons to manually realize its functions, such as
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turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature 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 pads and electrode garments, which could be packaged separately and/or together with the subject device.
5. Indications for Use
TENS (Modes 1, 2, 4, 5, 6, 8)
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.
PMS (also called EMS, Modes 1, 3, 7)
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.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating Mode
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 predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| Subject Device | Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510(k) Number | K162517 | K162517 | K153520 | K070299 |
| Submitter/Manufacturer | JKH Health Co., Ltd. | JKH Health Co., Ltd. | JKH Health Co., Ltd. | ezFit Technology, Inc. |
| Device Name/Model | PL-029K12 | PL-029K13 | PL-029K6 | ezFit Digital Heating TENS |
| Intended Use | TENS ModeTo be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,arm, and leg, due to strainfrom exercise or normalhousehold and workactivities.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis. | TENS ModeTo be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,arm, and leg, due to strainfrom exercise or normalhousehold and workactivities.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis. | TENSTo be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,arm, and leg, due to strainfrom exercise or normalhousehold and workactivities.It is also intended forsymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis. | For TranscutaneousElectrical NerveStimulation, ezFit DigitalHeating TENS (Model No.:HR-661/UC-101) isintended forSymptomatic relief andmanagement of chronicintractable pain.For powered heatingtherapy, ezFit DigitalHeating TENS (Model No.:HR-661/UC-101) isintended for |
Table 1. Device comparison
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| PMS ModeTo stimulate healthy musclesin order to improve andfacilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.It is also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities. | PMS ModeTo stimulate healthy musclesin order to improve andfacilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.It is also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities.Heating ModeTemporary relief of minoraches and pains | PMSTo stimulate healthy musclesin order to improve andfacilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.It is also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities. | Temporary relief of minoraches and pains and musclespasms | |
|---|---|---|---|---|
| Prescription or OTC | OTC | OTC | OTC | Prescription |
| Power Source(s) | Rechargeable battery | Rechargeable battery | Rechargeable battery | Rechargeable battery |
| Functions and design | Electrical stimulation | Electrical stimulation andheat | Electrical stimulation | Electrical stimulation andheat |
| Heating Setting | N/A | Low and high | N/A | Adjustable (36-42 °C) |
| Maximum temperature setting | N/A | 43 °C | N/A | 42 °C |
| Maximum output voltage(Volts +/- 20%) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 36.4Mode 3: 47.6Mode 4: 57.6Mode 5: 29.6Mode 6: 29.6Mode 7: 40.8Mode 8: 24.0 | Mode 1: This mode cyclesthe following modesMode 2: 31.2Mode 3: 46.0Mode 4: 42.0Mode 5: 27.6Mode 6: 27.6Mode 7: 40.8Mode 8: 23.2 | Mode 1: This mode cyclesthe following modesMode 2: 39.2Mode 3: 64Mode 4: 56.8Mode 5: 33.2Mode 6: 31.6 | Undisclosed |
| Maximum output voltage(Volts +/- 20%) at 2kΩ | Mode 1: This mode cyclesthe following modesMode 2: 80.8Mode 3: 96.0Mode 4: 93.6Mode 5: 66.4Mode 6: 66.4Mode 7: 86.4Mode 8: 53.6 | Mode 1: This mode cyclesthe following modesMode 2: 68.0Mode 3: 90.4Mode 4: 68.8Mode 5: 60.0Mode 6: 60.0Mode 7: 84.0Mode 8: 50.4 | Mode 1: This mode cyclesthe following modesMode 2: 82.4Mode 3: 84Mode 4: 79.2Mode 5: 70.4Mode 6: 67.2 | Undisclosed |
| Maximum output voltage(Volts +/- 20%) at 10kΩ | Mode 1: This mode cyclesthe following modesMode 2: 134Mode 3: 132Mode 4: 108Mode 5: 126Mode 6: 126Mode 7: 129Mode 8: 105 | Mode 1: This mode cyclesthe following modesMode 2: 118Mode 3: 124Mode 4: 78.4Mode 5: 115Mode 6: 115Mode 7: 124Mode 8: 99.2 | Mode 1: This mode cyclesthe following modesMode 2: 129Mode 3: 120Mode 4: 84.8Mode 5: 121Mode 6: 124 | Undisclosed |
| Maximum output current(mA +/- 20%) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 72.8Mode 3: 95.2Mode 4: 115.2Mode 5: 59.2 | Mode 1: This mode cyclesthe following modesMode 2: 62.4Mode 3: 92.0Mode 4: 84.0Mode 5: 55.2 | Mode 1: This mode cyclesthe following modesMode 2: 78.4Mode 3: 128Mode 4: 113.6Mode 5: 64.4 | Undisclosed |
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| Mode 6: 59.2Mode 7: 81.6Mode 8: 48.0 | Mode 6: 55.2Mode 7: 81.6Mode 8: 46.4 | Mode 6: 63.2 | |||||
|---|---|---|---|---|---|---|---|
| Maximum output current(mA +/- 20%) at 2KΩ | Mode 1: This mode cyclesthe following modesMode 2: 40.4Mode 3: 48.0Mode 4: 46.8Mode 5: 33.2Mode 6: 33.2Mode 7: 43.2Mode 8: 26.8 | Mode 1: This mode cyclesthe following modesMode 2: 34.0Mode 3: 45.2Mode 4: 34.4Mode 5: 30.0Mode 6: 30.0Mode 7: 42.0Mode 8: 25.2 | Mode 1: This mode cyclesthe following modesMode 2: 41.2Mode 3: 42Mode 4: 39.6Mode 5: 35.2Mode 6: 33.6 | Undisclosed | |||
| Maximum output current(mA +/- 20%) at 10KΩ | Mode 1: This mode cyclesthe following modesMode 2: 13.4Mode 3: 13.2Mode 4: 10.8Mode 5: 12.6Mode 6: 12.6Mode 7: 12.9Mode 8: 10.5 | Mode 1: This mode cyclesthe following modesMode 2: 11.8Mode 3: 12.4Mode 4: 7.84Mode 5: 11.5Mode 6: 11.5Mode 7: 12.4Mode 8: 9.92 | Mode 1: This mode cyclesthe following modesMode 2: 12.9Mode 3: 12Mode 4: 8.5Mode 5: 12.1Mode 6: 12.4 | Undisclosed | |||
| Pulse period (mSec) | 6.4~840 | 5.6~806 | 10~833 | Undisclosed | |||
| Frequency (Hz) | Mode 1: This mode cyclesthe following modesMode 2: 62.5Mode 3: 12.8~54.3Mode 4: 1.19Mode 5: 104.1Mode 6: 104.1Mode 7: 19.8Mode 8: 156.2 | Mode 1: This mode cyclesthe following modesMode 2: 73.5Mode 3: 13.7~59.5Mode 4: 1.24Mode 5: 104.1Mode 6: 104.1Mode 7: 20.8Mode 8: 178.5 | Mode 1: This mode cyclesthe following modesMode 2: 69.4Mode 3: 13.0~52.1Mode 4: 1.2Mode 5: 96.2Mode 6: 96.2 | Undisclosed | |||
| Maximum Phase charge(µC) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 14.6Mode 3: 19.0Mode 4: 23.0Mode 5: 11.8Mode 6: 11.8Mode 7: 16.3Mode 8: 9.6 | Mode 1: This mode cyclesthe following modesMode 2: 11.5Mode 3: 16.9Mode 4: 15.5Mode 5: 10.2Mode 6: 10.2Mode 7: 15.0Mode 8: 8.54 | Mode 1: This mode cyclesthe following modesMode 2: 15.1Mode 3: 25.6Mode 4: 18.2Mode 5: 12.8Mode 6: 10.1 | Undisclosed | |||
| Maximum current density(mA/cm²) at 500Ω | Mode 1:This mode cyclesthe following modesMode 2: 2.02Mode 3: 2.64Mode 4: 3.20Mode 5: 1.64Mode 6: 1.64Mode 7: 3.26Mode 8: 1.92 | Mode 1:This mode cyclesthe following modesMode 2: 2.23Mode 3: 3.29Mode 4: 3.00Mode 5: 1.97Mode 6: 1.97Mode 7: 2.91Mode 8: 1.66 | Mode 1:This mode cyclesthe following modesMode 2: 2.18Mode 3: 3.56Mode 4: 3.16Mode 5: 1.84Mode 6: 1.76 | Undisclosed | |||
| Maximum average powerdensity (mW/cm²) at 500Ω | Mode 4: 0.04 | Mode 1: This mode cyclesthe following modesMode 2: 0.92Mode 3: 0.32~1.37 | Mode 4: 0.03 | Mode 1: This mode cyclesthe following modesMode 2: 0.94Mode 3: 0.38~1.65 | Mode 4: 0.03 | Mode 1: This mode cyclesthe following modesMode 2: 1.14Mode 3: 0.64~2.56 | Undisclosed |
| Mode 5: 1.01 | Mode 5: 1.04 | Mode 5: 1.13 | |||||
| Mode 6: 1.01 | Mode 6: 1.04 | Mode 6: 0.85 | |||||
| Mode 7: 0.53 | Mode 7: 0.46 | ||||||
| Mode 8: 1.44 | Mode 8: 1.26 |
7. Substantial Equivalence
As shown in the above comparison Table 1, the six modes of the predicate PL-029K6 (K153520) are the first six preset modes in both of the subject devices PL-029K12 and PL-029K13. The seventh and eighth preset modes of PL-029K12 and PL-029K13 have the technical characteristics (such as
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maximum output voltage, maximum output current, maximum current density, and maximum average power density) almost the same as the six modes of the predicate device. Also, the changes to the display on the subject device do not affect the safety or effectiveness. Accordingly, the subject devices PL-029K12 and PL-029K13 are substantially equivalent to the predicate device PL-029K6, and the same intended use of PL-029K6 as TENS and PMS could apply to PL-029K12 and PL-029K13.
In addition to the TENS and PMS modes, the subject device PL-029K13 also has a heating mode, and is compared to the predicate device that could deliver electrical stimulation and heat separately and simultaneously in K070299. Similar to the predicate device, the subject device is used for the electrical stimulation or heat; consult with your physician before using electrical stimulation and heat simultaneously. The subject device delivers heat through the same technology as the predicate device, and is viewed as substantially equivalent to the predicate device of the exact same technology and substantially equivalent indications for use. The differences that exist between the subject and predicate devices are insignificant in the terms of safety or effectiveness.
Design and Technology - The basic design and technology of providing electrical stimulation and heat is the same or similar.
Performance and Specifications - The subject device has similar electrical stimulation and heat performance and specifications to the predicate device.
Indications - The indications are similar.
Prescriptive - The predicate K070299 is for prescription, while the remaining predicate and subject devices are for OTC.
As demonstrated, the differences between the subject and predicate devices do not affect the intended use or alter the fundamental 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, safety, and effectiveness as the predicate device.
The same electrode pads and garments cleared from the predicate K153520 could apply to the subject device. Also, other-shape electrode pads and garments with the same components, such as conductive shoes, socks, belts, wraps, , will not change the biocompatibility or safety. Some electrodes used have an additional heating layer inside, compared to the K153520 cleared electrode. This heating layer isolated inside the electrode could not be touched by the user and does not raise any biocompatibility issue. Concerns of the safe and proper use of the electrodes and other accessories have been fully addressed through details in the Labeling.
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".
In addition to the compliance of voluntary standards, the verification of software used in the subject
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device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The electrode pads, electrode garments, and other accessories of the subject device also meet the requirement of safety.
The skin temperatures were measured at Mode 8 with the largest frequency of 160 Hz among the eight preset modes, the highest Intensity Level 20, and the highest Heat Level 2 for 60 min. The results showed the subject device reached the highest skin temperature of about 41 °C in 20 min, and then kept stable.
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).