(125 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 Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
The provided document is an FDA 510(k) Pre-Market Notification for an Electronic Pulse Stimulator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices based on technical characteristics and adherence to recognized electrical safety and electromagnetic compatibility standards. There is no mention of a clinical study or performance metrics related to diagnostic accuracy, sensitivity, specificity, etc., which are common for AI/ML device evaluations.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address the points that can be gleamed from the document.
Acceptance Criteria and Device Performance for Electronic Pulse Stimulator (K141260)
Based on the provided FDA 510(k) summary, the "acceptance criteria" are related to demonstrating substantial equivalence in technical specifications (electrical output parameters, pulse characteristics), intended use, and compliance with recognized safety standards. Performance is reported in terms of these technical specifications compared to predicate devices. There is no explicit acceptance criteria for efficacy beyond demonstrating similar technical function to predicate devices and adherence to general safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied: Similar to Predicate Devices & within specified ranges) | Reported Device Performance (Subject Device - PL-029BL / PL-029K Ranges) | Predicate Device Performance (K131921 / K131290 Ranges) |
|---|---|---|---|
| Electrical Output Parameters (+/- 20% tolerance listed for voltage/current) | |||
| Max Output Voltage (500Ω) | Consistent with predicate devices | 24.0 - 75.2 V (PL-029BL), 37.2 - 71.2 V (PL-029K) | 49.6 V (K131921), 32 - 64 V (K131290) |
| Max Output Voltage (2kΩ) | Consistent with predicate devices | 46.4 - 121 V (PL-029BL), 64.8 - 122 V (PL-029K) | 99.2 V (K131921), 64 - 94.4 V (K131290) |
| Max Output Voltage (10kΩ) | Consistent with predicate devices | 85.6 - 134 V (PL-029BL), 96.8 - 146 V (PL-029K) | 114 V (K131921), 96.8 - 129 V (K131290) |
| Max Output Current (500Ω) | Consistent with predicate devices | 48.0 - 150.4 mA (PL-029BL), 74.4 - 142.4 mA (PL-029K) | 18 mA (K131921), 64 - 128 mA (K131290) |
| Max Output Current (2kΩ) | Consistent with predicate devices | 23.2 - 60.5 mA (PL-029BL), 32.4 - 61 mA (PL-029K) | 3.2 mA (K131921), 32 - 47.2 mA (K131290) |
| Max Output Current (10kΩ) | Consistent with predicate devices | 8.5 - 13.4 mA (PL-029BL), 9.7 - 14.6 mA (PL-029K) | 0.6 mA (K131921), 9.7 - 12.9 mA (K131290) |
| Pulse Width (µSec) | Similar to predicate devices | 100 µSec (PL-029BL), 50-100 µSec (PL-029K) | 50-140 µSec (K131921), 100 µSec (K131290) |
| Pulse Period (mSec) | Similar to predicate devices | 6.1-824 mSec (PL-029BL), 12-832 mSec (PL-029K) | 40 mSec (K131921), 10-840 mSec (K131290) |
| Frequency (Hz) | Similar to predicate devices | 1.2-164.4 Hz (PL-029BL), 1.2-83.3 Hz (PL-029K) | 86 Hz (K131921), 1.2-100 Hz (K131290) |
| Max Phase Charge (µC) at 500Ω | Similar to predicate devices | 9.2 - 31.3 µC (PL-029BL), 3.7 - 33.0 µC (PL-029K) | 23 µC (K131921), 12.8 - 27.3 µC (K131290) |
| Max Current Density (mA/cm²) at 500Ω | Similar to predicate devices | 1.92-6.02 (PL-029BL), 4.65-8.90 (PL-029K) | 1.4 (K131921), 2.56-5.12 (K131290) |
| Max Avg Power Density (mW/cm²) at 500Ω | Similar to predicate devices | 0.07-3.45 (PL-029BL), 0.12-3.10 (PL-029K) | Not explicitly listed for all modes (K131921), 0.08-3.75 (K131290) |
| Safety and EMC Standards | Compliance with IEC 60601-1, -1-2, -2-10 | All tests performed, design validated, and conformance assured. | Predicate devices also complied with relevant standards. |
| Software Verification | Conformance with FDA Guidance for Software Contained in Medical Devices | Verification performed according to FDA Guidance. | Not explicitly mentioned but assumed for predicate devices. |
| Biocompatibility | Electrodes meet safety requirements | Electrodes meet safety requirements. | Not explicitly mentioned but assumed for predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on engineering bench testing and comparison to predicate device specifications, not a clinical test set with patient data.
- Data Provenance: Not applicable in the context of clinical studies. The data related to electrical output parameters are from bench tests of the subject device and specifications of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the clinical sense was established by experts for a test set. The validation focused on whether the device's technical specifications met engineering requirements and were comparable to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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 an Electronic Pulse Stimulator, not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device's performance is standalone in the sense of its physical output, but there's no "algorithm-only" performance study in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this type of device, "ground truth" relates to the accurate measurement of electrical output parameters and compliance with recognized safety standards (e.g., IEC 60601 series). The "truth" is whether the device produces the specified electrical pulses safely and reproducibly.
8. The sample size for the training set:
- Not applicable. There is no AI/ML component, thus no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML component, thus no training set or associated ground truth.
Summary of the Study (Device Evaluation):
The "study" presented is a non-clinical evaluation demonstrating substantial equivalence of the Electronic Pulse Stimulator (K141260) to previously cleared predicate devices (K131921 and K131290).
- Methodology: The evaluation involved comparing the subject device's technical characteristics (e.g., maximum output voltage and current, pulse width, frequency, phase charge, current density, power density) with those of the predicate devices. Deviations in these parameters were assessed for their impact on safety and effectiveness.
- Key Findings: The submission states that "The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness."
- Supporting Tests: The device underwent several non-clinical tests to ensure safety and performance, including:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic Compatibility requirements and tests.
- IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- Verification of software in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Biocompatibility assessment of the electrode pads.
- Conclusion: Based on these non-clinical tests and the comparison of technical specifications, the submitter concluded that the subject device is substantially equivalent to the predicate devices and is as safe and effective for its intended over-the-counter use for temporary pain relief.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
Shenzhen Jingkehui Electronic Co. LTD c/o Bill Quanqin Dai, Ph.D. Application Correspondent 513 Piazza Drive, Unit B Mountain View, CA, 94043
Re: 510(k) Number: K141260 Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Neurology Regulatory Class: Class II Product Code: NUH Dated: Aug 16th 2014 Received: Aug 20th 2014
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
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" (21CFR 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 yours.
Felipe Aguel -S
Carlos Pena, Ph.D. for
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) K141260
Device Name
Electronic Pulse Stimulator
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)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.09.17 15:39:53 -04'00'
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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: Shenzhen Jingkehui Electronic Co., Ltd. Address: 5F, Building 12, Hengmingzhu Industrial Park, Xiangxing Road, Shajing, Baoan District, Shenzhen, China Contact Person: Pu Jiang Tel: +86-755-29970323 Fax: +86-755-23493443 Email: bill@JKHhealth.com Date of Preparation: 05/12/2014
2. Subject Device
Trade/Device Name: Electronic Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator (TENS) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Definition: Temporary relief of pain due to sore/aching muscles Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter
3. Predicate device
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K131921 Use: Over-The-Counter Submitter: Shenzhen Jingkehui Electronic Co., Ltd.
Predicate Device: IQ Technologies 510(k) Number: K131290 Use: Over-The-Counter Submitter: IO Technologies Inc.
4. Description of Subject Device
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-thecounter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
5. Intended Use of Subject Device
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.
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6. Summary of Substantial Equivalence
The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics of the subject device are substantially equivalent to those of the predicate devices.
| Parameter | Subject Device | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| 510(k) Number | K141260 | K141260 | K131921 | K131290 |
| Device Name/Model | ElectronicPulseStimulator/PL-029BL | ElectronicPulseStimulator/PL-029K | ElectronicPulseStimulator/PL-029 | IQ Technologies |
| Maximum outputvoltage (Volts +/-20%) at 500Ω | Mode 1: 41.6Mode 2: 66.4Mode 3: 60.8Mode 4: 35.2Mode 5: 32.8Mode 6: This modecycles the abovemodesMode 7: 75.2Mode 8: 24.0 | Mode 1: 46.0Mode 2: 59.6Mode 3: 49.2Mode 4: 64.8Mode 5: 37.2Mode 6: This modecycles the abovemodesMode 7: 71.2Mode 8: 64.0 | 49.6 | Mode 1: 42Mode 2: 63.2Mode 3: 64Mode 4: 34.4Mode 5: 32Mode 6: Thismode cycles theabove modes |
| Maximum outputvoltage (Volts +/-20%) at 2ΚΩ | Mode 1: 80.0Mode 2: 100Mode 3: 83.2Mode 4: 70.4Mode 5: 67.2Mode 6: This modecycles the abovemodesMode 7: 121Mode 8: 46.4 | Mode 1: 86.4Mode 2: 111Mode 3: 80Mode 4: 90.4Mode 5: 64.8Mode 6: This modecycles the abovemodesMode 7: 122Mode 8: 89.6 | 99.2 | Mode 1: 80.8Mode 2: 94.4Mode 3: 87.2Mode 4: 68Mode 5: 64Mode 6: Thismode cycles theabove modes |
| Maximum outputvoltage (Volts +/-20%) at 10kΩ | Mode 1: 125Mode 2: 128Mode 3: 84.8Mode 4: 123Mode 5: 116Mode 6: This modecycles the abovemodesMode 7: 134Mode 8: 85.6 | Mode 1: 116Mode 2: 146Mode 3: 138Mode 4: 106Mode 5: 111Mode 6: This modecycles the abovemodesMode 7: 136Mode 8: 96.8 | 114 | Mode 1: 129Mode 2: 129Mode 3: 96.8Mode 4: 128Mode 5: 119Mode 6: Thismode cycles theabove modes |
| Maximum outputcurrent (mA +/- 20%)at 500Ω | Mode 1: 83.2Mode 2: 132.8Mode 3: 121.6Mode 4: 70.4Mode 5: 65.6Mode 6: This modecycles the abovemodes | Mode 1: 92.0Mode 2: 119.2Mode 3: 98.4Mode 4: 129.6Mode 5: 74.4Mode 6: This modecycles the abovemodes | 18 | Mode 1: 84Mode 2: 126.4Mode 3: 128Mode 4: 68.8Mode 5: 64Mode 6: Thismode cycles the |
| modes | modes | above modes | ||
| Mode 7: 150.4 | Mode 7: 142.4 | |||
| Mode 8: 48.0 | Mode 8: 128.0 | |||
| Maximum outputcurrent (mA +/- 20%)at 2ΚΩ | Mode 1: 40.0 | Mode 1: 43.2 | 3.2 | Mode 1: 40.4 |
| Mode 2: 50 | Mode 2: 55.5 | Mode 2: 47.2 | ||
| Mode 3: 41.6 | Mode 3: 40 | Mode 3: 43.6 | ||
| Mode 4: 35.2 | Mode 4: 45.2 | Mode 4: 34 | ||
| Mode 5: 33.6 | Mode 5: 32.4 | Mode 5: 32 | ||
| Mode 6: This modecycles the abovemodes | Mode 6: This modecycles the abovemodes | Mode 6: Thismode cycles theabove modes | ||
| Mode 7: 60.5 | Mode 7: 61 | |||
| Mode 8: 23.2 | Mode 8: 44.8 | |||
| Maximum outputcurrent (mA +/- 20%)at 10KΩ | Mode 1: 12.5 | Mode 1: 11.6 | 0.6 | Mode 1: 12.9 |
| Mode 2: 12.8 | Mode 2: 14.6 | Mode 2: 12.9 | ||
| Mode 3: 8.5 | Mode 3: 13.8 | Mode 3: 9.7 | ||
| Mode 4: 12.3 | Mode 4: 10.6 | Mode 4: 12.8 | ||
| Mode 5: 11.6 | Mode 5: 11.1 | Mode 5: 11.9 | ||
| Mode 6: This modecycles the abovemodes | Mode 6: This modecycles the abovemodes | Mode 6: Thismode cycles theabove modes | ||
| Mode 7: 13.4 | Mode 7: 13.6 | |||
| Mode 8: 8.6 | Mode 8: 9.7 | |||
| Pulse Width (μSec) | 100 | 50~100 | 50~140 | 100 |
| Pulse period (mSec) | 6.1~824 | 12~832 | 40 | 10~840 |
| Frequency (Hz) | Mode 1: 69.4 | Mode 1: 54.3 | 86 | Mode 1: 69.4 |
| Mode 2: 12.8~53.2 | Mode 2: 35.7 | Mode 2: 12.3~54.3 | ||
| Mode 3: 1.2 | Mode 3: 62.5 | Mode 3: 1.2 | ||
| Mode 4: 96.2 | Mode 4: 6.7 | Mode 4: 100 | ||
| Mode 5: 96.2 | Mode 5: 83.3 | Mode 5: 100 | ||
| Mode 6: This modecycles the abovemodes | Mode 6: This modecycles the abovemodes | Mode 6: Thismode cycles theabove modes | ||
| Mode 7: 19.2 | Mode 7: 19.8 | |||
| Mode 8: 164.4 | Mode 8: 1.2 | |||
| Maximum Phasecharge (µC) at 500Ω | Mode 1: 17.3 | Mode 1: 19.9 | 23 | Mode 1: 18.1 |
| Mode 2: 24.4 | Mode 2: 6.0 | Mode 2: 27.3 | ||
| Mode 3: 24.3 | Mode 3: 4.9 | Mode 3: 25.6 | ||
| Mode 4: 14.6 | Mode 4: 6.5 | Mode 4: 14.9 | ||
| Mode 5: 12.6 | Mode 5: 3.7 | Mode 5: 12.8 | ||
| Mode 6: This modecycles the abovemodes | Mode 6: This modecycles the abovemodes | Mode 6: Thismode cycles theabove modes | ||
| Mode 7: 31.3 | Mode 7: 33.0 | |||
| Mode 8: 9.2 | Mode 8: 25.6 | |||
| Maximum currentdensity (mA/cm2) | Mode 1: 3.33 | Mode 1: 5.75 | 1.4 | Mode 1: 3.36 |
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| 500Ω | Mode 3: 4.86Mode 4: 2.82Mode 5: 2.62Mode 6: This mode cycles the above modesMode 7: 6.02Mode 8: 1.92 | Mode 3: 6.15Mode 4: 8.10Mode 5: 4.65Mode 6: This mode cycles the above modesMode 7: 8.90Mode 8: 8.00 | 0.23 | Mode 3: 5.12Mode 4: 2.75Mode 5: 2.56Mode 6: This mode cycles the above modes |
|---|---|---|---|---|
| Maximum average power density (mW/cm²) at 500Ω | Mode 1: 2.00Mode 2: 0.83~3.45Mode 3: 0.07Mode 4: 1.98Mode 5: 1.59Mode 6: This mode cycles the above modesMode 7: 1.81Mode 8: 1.45 | Mode 1: 3.10Mode 2: 0.79Mode 3: 0.95Mode 4: 0.18Mode 5: 0.72Mode 6: This mode cycles the above modesMode 7: 2.91Mode 8: 0.12 | Mode 1: 2.11Mode 2: 0.85~3.75Mode 3: 0.08Mode 4: 2.05Mode 5: 1.64Mode 6: This mode cycles the above modes |
7. Substantial Equivalence
The operational principle of the above predicate device is to generate small pulses of electrical current and deliver the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
Identically, the subject device generates small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
The comparison between the subject device and predicate devices demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.
The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests, such as IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10, further demonstrate these differences maintain the same safety and effectiveness as those of the 510(k) cleared predicate devices. In other words, these differences 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, and effective results as the predicate devices.
Concerns of the safe and proper use of the biocompatible electrode pads have been fully addressed by making the use conscious of the proper placement of the electrode pads and appropriate operations of the device 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
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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 device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.
9. Conclusion
The tests performed and the comparison of technical characteristics, specifications, 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 foregoing identified OTC predicate devices that have 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).