The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Device Description

The OTC Patch, model WL-2406 is a single channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The outbut and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit. The OTC Patch, model WL-2406, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief. The stimulation modes for OTC Patch is pre-program modes with fixed pulse rate, frequency, and fixed timer, only amplitude is adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model WL-2406(K052785). Every operation mode of OTC Patch, model WL-2406 has its individual stimulation operation cycle. For the device included in this submission, we use the following of our 510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series/ model no. CM-130x70, size 130x70mm, snap type. With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

AI/ML Overview

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, the OTC Patch, Model WL-2406. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving independent efficacy through new clinical studies measuring clinical outcomes against acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for an AI/CADe device. Instead, the "study" described is a non-clinical comparison to predicate devices.

However, I can interpret the request in the context of the provided document by extracting the comparison data that serves as the basis for the "substantial equivalence" claim.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) for a TENS device, "acceptance criteria" are typically met by demonstrating that the new device shares the same intended use, fundamental technological characteristics, and similar performance specifications as legally marketed predicate devices, or that any differences do not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to these predicates.

Feature	Acceptance Criteria (Predicate Device K052785, WL-2406)	Acceptance Criteria (Predicate Device K091757, WL-2407)	Reported Device Performance (New Device WL-2406)
Intended Use	Temporary relief of pain in low back	Temporary relief of pain in upper/lower extremities	Temporary relief of pain in low back and upper/lower extremities
Regulation Number	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890
Regulatory Class	II	II	II
Product Code	NUH	NUH	NUH
Waveform	Biphasic	Biphasic	Biphasic
Shape	Rectangular	Rectangular	Rectangular
Max Output Voltage	25V @500Ω, 45V @2KΩ, 75V @10KΩ	40V @500Ω, 60V @2KΩ, 100V @10KΩ	25V @500Ω, 45V @2KΩ, 75V @10KΩ
Max Output Current	50mA @500Ω, 22.5mA @2KΩ, 7.5mA @10KΩ	80mA @500Ω, 30mA @2KΩ, 10mA @10KΩ	50mA @500Ω, 22.5mA @2KΩ, 7.5mA @10KΩ
Duration of primary phase	260 max µsec	260 max µsec	260 max µsec
Pulse Duration	8700 max µsec	650 max µsec	8700 max µsec
Frequency	120 max Hz	60 max Hz	120 max Hz
Symmetrical phases?	Yes	Yes	Yes
Power Source	1.5Vx2 (AAA Size)	1.5Vx3 (AAA Size)	1.5Vx2 (AAA Size)
Method of Line Current Isolation	Type BF	Type BF	Type BF
Patient Leakage Current (Normal)	Under 0.1 uA	Under 0.1 uA	Under 0.1 uA
Patient Leakage Current (Single Fault)	Under 0.5 uA	Under 0.5 uA	Under 0.5 uA
Number of Output Modes	8	8	8
Number of Output Channels	Synchronous, Output Coil	Synchronous, Output Coil	Synchronous, Output Coil
Regulated	Voltage	Voltage	Voltage
Software/Firmware/Microprocessor control?	Yes	Yes	Yes
Automatic No-Load Trip?	Yes	Yes	Yes
Automatic Shut Off?	Yes	Yes	Yes
Low Battery Indicator?	Yes	Yes	Yes
Voltage/Current Level Indicator?	Yes	Yes	Yes
Timer Range	10-60 Minutes	5-60 Minutes	10-60 Minutes
Compliance with Voluntary Standards	IEC 60601-2-10	IEC 60601-2-10	IEC 60601-2-10
Compliance with 21 CFR 898?	Yes	Yes	Yes
Housing Materials	ABS	ABS	ABS
Method of achieving zero net charge	Biphasic symmetric wave for each	Biphasic symmetric wave for each	Biphasic symmetric wave for each
Electrode Used	Belt Electrode (5 X 5 cm)/K082065	Belt Electrode and/or Self Adhesive Electrode(5 X 5 cm)/K082065	Self Adhesive Electrode (13x7 cm)/K082065
Max. phase charge	13 uc	20.8 uc	13 uc
Max. current Density	0.0246 mA/cm²	0.04992 mA/cm²	0.04875 mA/cm²
Max. Average current (RMSA) @500Ω	50 mA	80 mA	50 mA
Max. Power Density	0.00156 Watts/ cm²	0.00200 Watts/ cm²	0.001219 Watts/ cm²

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical bench testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the traditional sense of a clinical trial with patient data. The "test set" here refers to the device parameters and performance characteristics which are compared against those of the predicate devices. This involves analyzing the technical specifications and output characteristics of the new device.
Data Provenance: The data comes from the technical specifications, design documents, and bench testing of the new device (OTC Patch, Model WL-2406) and the predicate devices (WL-2406 K052785, WL-2407 K091757). The document implies the origin is Well Life Healthcare Limited in Taiwan, ROC, the submitter. The data is retrospective in the sense that it relies on existing specifications of cleared devices and new device test results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. Ground truth, in this context, refers to the established specifications and performance of the predicate devices, as recognized by their previous 510(k) clearances. The evaluation is a comparative engineering assessment, not an expert review of clinical cases.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication" is essentially a comparison of the technical specifications and performance data of the new device against the established parameters of the predicate devices, as reviewed by the FDA.

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:

No. This is a TENS device, not an AI/CADe medical imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical device submission; there is no "algorithm only" performance concept here beyond the device's electrical characteristics. The device operates standalone in the sense that it delivers electrical stimulation as programmed without continuous human intervention during therapy, but it is not an AI diagnostic standalone system.

7. The Type of Ground Truth Used:

The "ground truth" for comparison is the technical specifications, output characteristics, safety standards compliance (e.g., IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2), and intended use of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:

Not applicable. (See #8)

Summary of the "Study" (Non-Clinical Comparison):

The "study" conducted for K133723 is a comprehensive non-clinical comparison study that evaluates the new device against two predicate TENS devices (K052785 and K091757). The core of this study involves:

Comparison of Intended Use: The new device combines and expands the indications of the two predicate devices, stating temporary relief of pain in "low back as well as upper and lower extremities (arm and/or leg)." This is considered substantively equivalent or a logical extension based on the predicate devices.
Comparison of Technological Characteristics: Detailed comparison tables (Sections 7, 8, and 9) provide side-by-side analysis of:
- Operational modes and pre-programmed parameters (fixed pulse rate, frequency, timer).
- Output characteristics (waveform, shape, max voltage, max current, pulse duration, frequency).
- Safety features (patient leakage current, isolation, automatic shut-off).
- Physical characteristics (power source, dimensions, materials).
- Electrode type and size.
Compliance with Voluntary Standards: The device demonstrates compliance with applicable voluntary standards, including IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2, as well as FDA software guidance. This demonstrates that the device meets recognized safety and performance benchmarks.
Detailed Calculation Comparison: "Through the detailed calculation comparison of stimulation output energy for each operation model in particular the output current density and power density), we found the output level in each operation mode for our OTC Patch, model WL-2406 and predicate device are very close and within the acceptable range as specified in FDA guidance." This explicitly addresses that despite slight differences in "detailed output parameters (mainly in the pulse duration and electrode sizes)," the overall output energy, current density, and power density are comparable and safe.
Conclusion of Substantial Equivalence: The study concludes that the new device has "the same intended use and the similar technological characteristics as the cleared devices" and that the "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." Meaning that the engineering differences do not affect intended use or alter the fundamental scientific technology.

This approach is standard for 510(k) submissions where a new device is substantially equivalent to a predicate device, and new large-scale clinical trials are not typically required unless there are significant changes in technology, indications, or safety profiles.

Summary

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510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K133723 .

1. Submitter's Identifications:

Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 234, Taiwan, ROC Contact: Jenny Hsieh Telephone: Date of Summary Preparation: November 15, 2013

2. Name of the Device:

Trade/Device Name: OTC Patch, Model: WL-2406. Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator. Regulatory Class: II Product Code: NUH

3. Information of the 510(k) Cleared Device (Predicate Device):

K052785: OTC TENS For Low Back Pain Relief/ Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief/ Model WL-2407.

4. Device Description:

The OTC Patch, model WL-2406, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for OTC Patch is pre-program modes with fixed pulse rate, frequency, and fixed timer, only amplitude is adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model WL-2406(K052785). Every operation mode of OTC Patch, model WL-2406 has its individual stimulation operation cycle.

For the device included in this submission, we use the following of our 510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series/ model no. CM-130x70, size 130x70mm, snap type.

With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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ട. Intended Use:

The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back and/or upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes IEC 60601-2-10, as well as IEC 60601-1, and IEC 60601-1-2 requirement. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.

7. Comparison of Significant device features

Features	510(K) Cleared Models	New Model
Model	WL-2406	WL-2407	WL-2406
510(K) No.	K052785	K091757	Unknown
Prescription or OTC	OTC	OTC	OTC
Indication for use	temporary relief of painassociated with sore andaching muscles in the lowback due to strain fromexercise or normal House-hold and work activities	temporary relief of painassociated with sore andaching muscles in the upperAnd lower extremities (armand/or leg) due to strain fromexercise or normal House-hold and work activities	temporary relief of painassociated with sore andaching muscles in the lowback as well as upper andlower extremities (arm and/or leg) due to strain fromexercise or normal House-hold and work activities
FDA product code	NUH	NUH	NUH
Electrode Used	Belt Electrode(5 X 5 cm)/K082065	Belt Electrode and/orSelf Adhesive Electrode(5 X 5 cm)/K082065	Self Adhesive Electrode(13x7 cm)/K082065

8. Significant output characteristics comparison table:

Comparison feature	510(K) Cleared Model	New Model
	WL-2406(K052785)	WL-2407(K091757)	WL-2406
Net charge		0	0	0
Max. phase charge		13 uc	20.8 uc	13 uc
Max. current Density		0.0246 mA/cm²	0.04992 mA/cm²	0.04875 mA/cm²
Max. Average	500 Ω	50 mA	80 mA	50 mA
current	2K Ω	22.5 mA	30 mA	22.5 mA
(RMSA)	10 Ω	7.5 mA	10 mA	7.5 mA
Max. Power Density		0.00156 Watts/ cm²	0.00200 Watts/ cm²	0.001219 Watts/ cm²
Burst Mode		Yes	Yes	Yes

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9. Comparison of Unit Characteristics & Output Specification

		Predicate Device		New Device
		WL-2406	WL-2407	WL-2406 OTC Patch
Mode or Program Name
	Waveform (e.g., pulsed monophasic, biphasic)	Biphasic	Biphasic	Biphasic
	Shape (e.g., rectangular, spike, rectified sinusoidal)	Rectangular	Rectangular	Rectangular
	Maximum Output Voltage (volts) (+/- 20 %)	25V @500Ω45V @2KΩ75V @10KΩ	40V @500Ω60V @2KΩ100V @10KΩ	25V @500Ω45V @2KΩ75V @10KΩ
	Maximum Output Current (mA) (+/- 20 %)	50mA @500Ω22.5mA @2KΩ7.5mA @10KΩ	80mA @500Ω30mA @2KΩ10mA @10KΩ	50mA @500Ω22.5mA @2KΩ7.5mA @10KΩ
	Duration of primary phase (usec)	260 max	260 max	260 max
	Pulse Duration (usec)	8700 max	650 max	8700 max
	Frequency (Hz) [or Rate (pps)]	120 max	60 max	120 max
For multiphasic waveforms only:	Symmetrical phases?Phase Duration (include units),(Stage range, if applicable),(both phases, if asymmetrical)	Yes	Yes	Yes
		Not applicable	Not applicable	Not applicable
	510(K) Number	K052785	K091757	Unknown
	Device Name and Model	WL-2406	WL-2407	WL-2406 OTC Patch
	Manufacturer	Well-Life	Well-Life	Well-Life
	Power Source(s)	1.5Vx2 (AAA Size)	1.5Vx3 (AAA Size)	1.5Vx2 (AAA Size)
	- Method of Line current Isolation	Type BF	Type BF	Type BF
	- Patient Leakage Current	---	---	---
	- Normal condition (uA)	Under 0.1	Under 0.1	Under 0.1
	- single Fault condition (uA)	Under 0.5	Under 0.5	Under 0.5
	Average DC current through electrodes when device is on but no pulses are being applied (uA)	Not applicable	Not applicable	Not applicable
	Number of Output Modes	8	8	8
Number of Output Channels:	Synchronous or Alternating?Method of Channel Isolation	SynchronousOutput Coil	SynchronousOutput Coil	SynchronousOutput Coil
	Regulated Current or Regulated Voltage?	Voltage	Voltage	Voltage
	Software/Firmware/Microprocessor control?	Yes	Yes	Yes
	Automatic Overload Trip?	No	No	No
	Automatic No-Load Trip?	Yes	Yes	Yes
	Automatic Shut Off?	Yes	Yes	Yes
	User Override control?	No	No	No
	On/Off Status?	Yes	Yes	Yes
	Indicator Display:	Low Battery?Voltage/Current Level?	YesYesYes	YesYesYes
	Timer Range (Minutes)	10-60	5-60	10-60
	Compliance with Voluntary Standards?	IEC 60601-2-10	IEC 60601-2-10	IEC 60601-2-10
	Compliance with 21 CFR 898?	Yes	Yes	Yes
Weight (g) including batteryDimensions (mm.) [W x H x D]		51.668×60×17.5	125.590×50.8×12.7	51.668×60×17.5
	Housing Materials and construction	ABS	ABS	ABS
	Pulse per burst	Same for each program	Same for each program	Same for each program
Burst per second		Same for each program	Same for each program	Same for each program
Bust duration		Same for each program	Same for each program	Same for each program
	Duty Cycle	Same for each program	Same for each program	Same for each program
Method of achieving zero net charge for net		Biphasic symmetric	Biphasic symmetric	Biphasic symmetric
		wave for each	wave for each	wave for each
	charge/pulse

・

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10. Summary for the technology comparison.

Basically the OTC Patch, Model WL-2406 has the similar technological characteristics with the predicate device in the product design, material, energy source type, main program mode and the main output waveform ... etc. There exists some difference in the detailed output parameters (mainly in the pulse duration and electrode sizes). Through the detailed calculation comparison of stimulation output energy for each operation modelin particular the output current density and power density), we found the output level in each operation mode for our OTC Patch, model WL-2406 and predicate device are very close and within the acceptable range as specified in FDA guidance. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence.

11. Conclusions

The OTC Patch, Model: WL-2406 have the same intended use and the similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 28, 2014

Well-Life Healthcare Limited c/o Jenny Hsieh 1FL., No.16, Lane 454, Jungjeng Rd. Yunghe City, Taipei County 234, Taiwan, R.O.C.

Re: K133723

Trade/Device Name: Well-Life OTC Patch, model: WL-2406 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH Dated: December 4, 2013 Received: December 6, 2013

Dear Jenny Hsieh:

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 complics 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

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Page 2 - Jenny Hsieh

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133723

Device Name Well-Life OTC Patch, model: WL-2406

Indications for Use (Describe)

The OTC Patch, Model WL-2406, is intended for temporary relice of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

Type of Use (Select one or both, as applicable)

J 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) (Signalure)

Carlos L. Pena -

FORM FDA 3881 (1/14)

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Regulation Number and Section

§ 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).