The device is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Device Description

The ThermaCare® Quick Therapy TENS device is a wireless, two channels wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient use of the dedicated APP (iOS or Android) or remote control. Reusable, self-adhesive pads allow for discreet and convenient placement on multiple pain locations on the body. The ThermaCare® Quick Therapy TENS contains 23 TENS programs. It is designed to be used at home, by adults of all genders.

The ThermaCare® Quick Therapy TENS device contains one main TENS unit which is rechargeable and one remote control which is powered by 2 AAA batteries. The pads with attached TENS unit can then be applied to intact skin at the desired location for pain relief. Control of the ThermaCare® Quick Therapy TENS device is completed through the available TENS APP (iOS or Android)or remote control. The communication is done via Bluetooth Low Energy.

The device will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the App, setting and controlling therapy programs, and troubleshooting. The ThermaCare® Quick Therapy TENS consists of the following elements:
• Main device: generates the TENS pulses; connects to the electrode; controlled by APP on smart phone and remote control.
• Electrodes: Self-adhesive re-usable hydrogel electrodes connects to the device.
• APP on mobile device: The APP controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the mobile device and the main device.
• Remote control: The remote controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the remote control and the main device.
· Adapter (optional): for charging the battery unit via a micro-USB socket which connected with the adapter, and insert the adapter to the supply mains.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ThermaCare® Quick Therapy TENS (Model: TC001):

Based on the provided FDA 510(k) Summary, this document primarily focuses on establishing substantial equivalence to a predicate device (Wireless Pain Relieve Device, Model LT5018C, K173462), rather than detailing acceptance criteria for a novel device and studies proving it meets those criteria in a clinical performance sense.

The document primarily relies on bench testing and compliance with recognized standards to demonstrate the safety and effectiveness of the new device relative to the predicate. There is no evidence of a clinical study with human subjects to evaluate the device's performance against specific acceptance criteria for pain relief.

Therefore, many of the requested sections (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance) are not applicable or cannot be answered from the provided text, as these typically relate to clinical performance studies.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it demonstrates compliance with safety and technical standards, and shows the technical specifications and outputs are comparable to a legally marketed predicate device.

Here's a summary of the technical specifications and their comparison to the predicate device, which implicitly serve as a form of "acceptance" for substantial equivalence:

Characteristic	Acceptance Criteria (Predicate / Standard Compliance)	Reported Device Performance (TC001)
Intended Use	TENS for various pain relief (Predicate's TENS mode)	TENS for various pain relief
Power Source	DC 3.7V Li-ion (main), 2xAAA (remote)	DC 3.7V Li-ion (main), 2xAAA (remote)
Patient Leakage Current	0uA (DC), 2.0uA (AC) (Predicate)	0uA (DC), 29uA max (AC) (Tested to IEC 60601-1)
Avg DC current (no pulses)	0 (Predicate)	0
Output Modes	2 (TENS/EMS) (Predicate)	1 (TENS)
Output Channels	N/A (Predicate, implied single)	Alternating (Two channels, tested to IEC 60601-2-10)
Channel Isolation	N/A (Predicate)	By Electrical Circuit and Software (Tested to IEC 60601-1)
Regulated Current/Voltage	Current control (Predicate)	Current control
Software/Firmware Control	Yes (Predicate)	Yes
Automatic Overload Trip	Yes (Predicate)	Yes
Automatic No Load Trip	Yes (Predicate)	Yes
Automatic Shut off	Yes (Predicate)	Yes
User Override Control	Yes (Predicate)	Yes (Device, remote, APP controls)
On/Off Status Indicator	Yes (Predicate)	Yes
Low Battery Indicator	Yes (Predicate)	Yes
Voltage/Current Level Indicator	Yes (Predicate)	Yes
Timer Range	30 minutes (Predicate)	5-30 minutes (Tested to IEC 60601-2-10)
Weight	36g (main), 65g (remote) (Predicate)	32g (main), 55g (remote, without batteries) (Tested to IEC 60601-1)
Dimensions (HWL)	360x59x11.5mm (main), 115x53x25mm (remote) (Predicate)	80.5x45x13.5mm (main), 127x48.6x24.4mm (remote) (Tested to IEC 60601-1)
Housing Materials	ABS (Predicate)	ABS
Compliance 21 CFR 898	Yes (Predicate)	Yes
Compliance Voluntary Standards	IEC 60601-1, -1-2, -2-10, -1-11; ISO 10993-1, -5, -10 (Predicate)	IEC 60601-1, -1-2, -2-10, -1-11; ISO 10993-1, -5, -10
Waveform	Biphasic (Predicate)	Biphasic
Shape	Rectangular (Predicate)	Rectangular
Max Output Voltage (V) @ 500Ω	31 (Predicate)	30.4 (Tested to IEC 60601-2-10)
Max Output Voltage (V) @ 2kΩ	66 (Predicate)	70 (Tested to IEC 60601-2-10)
Max Output Voltage (V) @ 10kΩ	66 (Predicate)	70 (Tested to IEC 60601-2-10)
Max Output Current (mA) @ 500Ω	62 (Predicate)	60.8 (Tested to IEC 60601-2-10)
Max Output Current (mA) @ 2kΩ	33 (Predicate)	35 (Tested to IEC 60601-2-10)
Max Output Current (mA) @ 10kΩ	6.6 (Predicate)	7 (Tested to IEC 60601-2-10)
Pulse Duration (µsec)	150-250 (Predicate)	100-200 (Tested to IEC 60601-2-10)
Frequency (Hz)	2-100 (Predicate)	2-100
Max Phase Charge (uC) @ 500Ω	31 (Predicate)	24.32 (Tested to IEC 60601-2-10)
Max Current Density @ 500Ω	0.48mA/cm² (Predicate)	0.295mA/cm² (Tested to IEC 60601-2-10)
Max Avg Current (mA) @ 500Ω	1.2 (Predicate)	1.22 (Tested to IEC 60601-2-10)
Max Avg Power Density (mW/cm²) @ 500Ω	2.88 (Predicate)	1.8 (Tested to IEC 60601-2-10)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. The "testing" referred to in this document is primarily bench testing and compliance with international standards (biocompatibility, electrical safety, EMC, software V&V, output waveform testing), not a clinical study on human subjects.
Data Provenance: Not applicable for clinical performance data. The device manufacturer is Shenzhen Dongdixin Technology Co., Ltd. in Shenzhen, China (as seen in the correspondent's address). The testing was likely conducted in laboratories adhering to international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established by human experts for this submission type.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical adjudication was performed.

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), not an AI-powered diagnostic system involving human "readers."

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

Not applicable. This device is electrotherapy equipment, not an algorithm. Its performance specifications were tested in a standalone manner (bench testing).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the international performance and safety standards (e.g., IEC 60601 series, ISO 10993 series) and the specifications of a legally marketed predicate device. The studies performed (biocompatibility, electrical safety, EMC, software V&V, output waveform) aimed to prove that the new device adheres to these standards and has comparable technical characteristics to the predicate.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 15, 2018

Pfizer Inc. % Siping Yuan R.A. Specialist Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan, Shenzhen, Cn 518108

Re: K181102

Trade/Device Name: ThermaCare Quick Therapy TENS, TC001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: April 20, 2018 Received: April 26, 2018

Dear Siping Yuan:

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 mav, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Scott -S

for 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) K181102

Device Name ThermaCare® Quick Therapy TENS Model: TC001

Indications for Use (Describe)

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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005_510 (k) Summary Version: 1.1

510(k) SUMMARY

as required by section 21 CFR 807.92

ThermaCare® Quick Therapy TENS

Date of Submission:	04/23/2018
Submitter/510(k)Owner's Name:	Pfizer Inc.
Address:	235 East 42nd Street, New York, New York 10017,USA
Contact Person:	Nicola Romano
E-mail:	nicola.romano@pfizer.com
Tel:	973-660-5858
Correspondent's Name:	Shenzhen Dongdixin Technology Co., Ltd.
Address:	No.3 Building Xilibaimang Xusheng Industrial Estate,Nanshan, Shenzhen, CHINA 518108
CorrespondentContact:	Siping Yuan
E-mail:	ra@dundex.com
Tel:	+86(755) 27652471
FAX:	+86(755) 27652674

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1. Proposed Device:

Device Name:	ThermaCare® Quick Therapy TENS
Model:	TC001
Device classification Name:	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Description:	Transcutaneous electrical nerve stimulator for pain relief
Regulation Medical Specialty:	Neurology
Review Panel:	Neurology
Regulation Number:	882.5890
Product Code:	NUH
Device Class:	II
Device classification Name:	Stimulator, Electrical, Transcutaneous, For Arthritis
Regulation Description:	Transcutaneous electrical nerve stimulator for pain relief
Regulation Medical Specialty:	Neurology

Medical Specialty:	Neurology
Review Panel:	Neurology
Regulation Number:	882.5890
Product Code:	NYN
Device Class:	II

2. Predicate Device:

Legally Marketed Device:	Wireless Pain Relieve Device
	LT5018C
510(k) Number:	K173462
Manufacturer:	Shenzhen Dondixin Technology Co., Ltd.

3. Description of Proposed Device:

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communication is done via Bluetooth Low Energy.

• Main device: generates the TENS pulses; connects to the electrode; controlled by APP on smart phone and remote control.

• Electrodes: Self-adhesive re-usable hydrogel electrodes connects to the device.

• APP on mobile device: The APP controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the mobile device and the main device.

• Remote control: The remote controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the remote control and the main device.

· Adapter (optional): for charging the battery unit via a micro-USB socket which connected with the adapter, and insert the adapter to the supply mains.

4. Proposed Device Intended for Use Statement:

Device Name: ThermaCare® Quick Therapy TENS, Model: TC001

Indications for Use:

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5. Technological Characteristics and Substantial Equivalence

Both the TC001 and Predicate Device utilize the application of electrical current through electrodes placed on the impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated. Basic technological characteristics, new device vs. Predicate device.

		New device	Predicate device	S.E. Discussion
1	510K#	To be assigned	K173462	N/A
2	Device Name andModel	ThermaCare® Quick Therapy TENSMode: TC001	Wireless Pain Relieve DeviceMode: LT5018C	N/A
3	Applicant	Pfizer Inc.	Shenzhen Dongdixin Technology Co., Ltd	N/A
4	Manufacturer	Shenzhen Dongdixin Technology Co., Ltd	Shenzhen Dongdixin Technology Co., Ltd	Same
5	Intended for use	TENS: The device is designed to be usedfor temporary relief of pain associatedwith sore and aching muscles in theshoulder, waist, back, upper extremities(arm) and lower extremities (leg) due tostrain from exercise or normal householdwork activities. And to be used for thesymptomatic relief and management ofchronic, intractable pain and relief of painassociated with arthritis.	TENS: The device is designed to be usedfor temporary relief of pain associatedwith sore and aching muscles in theshoulder, waist, back, neck, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. Andto be used for the symptomatic reliefand management of chronic, intractablepain and relief of pain associated witharthritis.EMS: The device is designed to be usedfor stimulate healthy muscles in order toimprove and facilitate muscleperformance.	Applicant is not pursuingEMS use statement for thenew device.
6	Power Source	DC 3.7V Li-ion Battery(main device)DC 3.0V, 2 x AAA Batteries (Remotecontrol)	DC 3.7V Li-ion Battery(main device)DC 3.0V, 2 x AAA Batteries (Remotecontrol)	Same
	-Method ofLine	N/A	N/A	Same
	current isolation
	- Patient LeakageCurrent (μΑ)-Normal condition-Single faultcondition	d.c:0 uA. a.c.:29 uA maxd.c:0 uA. a.c.:69 uA max	0uA2.0uA	Different, TC 001 have beenevaluated and passed the testaccording to the requirementof IEC 60601-1.
7	Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ)	0	0	Same
8	Number of OutputModes	1 (TENS)	2 (TENS/EMS(including MASSAGE))	Different, TC001 only hasTENS mode and TC001remove indications for use ofEMS mode accordingly.
9	Number of Output Channels
	Synchronous orAlternating?	Alternating	N/A	Different, TC001 has twochannels and each channeloutputs have been evaluatedand passed the test accordingto the requirement of IEC60601-2-10.
	Method of ChannelIsolation	By Electrical Circuit and Software	N/A	Different, TC001 has twochannels and have beenevaluated and passed the testaccording to the requirementof IEC 60601-1.
10	Regulated Current orRegulated Voltage?	Current control	Current control	Same
11	Software/Firmware/Micro processorControl?	Yes	Yes	Same
12	Automatic OverloadTrip	Yes	Yes	Same
13	Automatic No Loadcontact Trip	Yes	Yes	Same
14	Automatic Shut off	Yes	Yes	Same
15	User OverrideControl?	YesPower [on/off] button on the devicePower [on/off] button on the remotecontrol[Stop session] button in the APP software	YesPower on/off button on the devicePower on/off on the remote controlPower on/off in the APP software	Same function
16	Indicator Display:
	On/Off Status?	Yes	Yes	Same
	Low Battery?	Yes	Yes	Same
	Voltage/CurrentLevel?	Yes	Yes	Same
17	TimerRange(minutes)	5-30 minutes	30 minutes	Different, new device havebeen evaluated and passedthe test according to therequirement of IEC60601-2-10.User can set the treatmenttime according their needs.
18	Weight (grams.)	32grams (Main device)55 grams (Remote control withoutbatteries)	36grams (Main device)65 grams (Remote control)	Different, the new devicehave been evaluated and
19	Dimensions(cm.)HW L	80.5(L)x45(W)x13.5(H)mm (Maindevice)127(L)x48.6(W)x24.4(H)mm (Remotecontrol)	360(L)x59(W)x11.5(H)mm(Maindevice)115(L)x53(W)x25(H)mm(Remotecontrol)	passed the testing accordingto the requirement of IEC60601-1.
20	Housing Materials &	ABS	ABS	Same

	Construction
21	Compliance with 21CFR 898	Yes	Yes	Same
22	Compliancewith	IEC 60601-1:2005+A1:2012	IEC 60601-1:2005+A1:2012	Same
	Voluntary Standards?	IEC 60601-1-2:2014	IEC 60601-1-2:2014
		IEC 60601-2-10: 2012	IEC 60601-2-10: 2012
		IEC60601-1-11: 2015	IEC60601-1-11: 2015
		ISO 10993-1:2009	ISO 10993-1:2009
		ISO 10993-5:2009	ISO 10993-5:2009
		ISO 10993-10:2010	ISO 10993-10:2010
	Table 2: Output Specification TENS mode
		New device	Predicate device	S.E. Discussion
1	510K#	To be assigned	K173462	N/A
2	Device Nameor	ThermaCare® Quick Therapy TENS	Wireless Pain Relieve Device	N / A
	Program Name	Mode:TC001	Mode:LT5018C
4	Waveform	Biphasic	Biphasic	Same
5	Shape	Rectangular	Rectangular	Same
6	Max Output Voltage (V) ±20%
7	500Ω	30.4	31	Similar, the new device have
8	2kΩ	70	66	been evaluated and passed
9	10kΩ	70	66	the test accordingto the
				requirementIECof
				60601-2-10.
10	Max Output Current (mA) ±20%
11	500Ω2kΩ	60.8	62	Similar, the new device havebeen evaluated and passed
1213		357	336.6	the test according to the
	10kΩ			requirement of
				IEC60601-2-10
14	PulseDuration	100~200us	150~250us	Similar, the new device have
	(µsec)			been evaluated and passed
				the test according to the
				ofrequirement
				IEC60601-2-10
15	Frequency (Hz)	2~100Hz	2~100Hz	Same
16	Maximum Phase	24.32	31	Similar, the new device have
	Charge (uC) 500Ω			been evaluated and passed
17	Maximum Current	0.295mA/cm2	0.48mA/cm2	the test according to the
	Density 500Ω			requirement of IEC
18	Maximum Average	1.22	1.2	60601-2-10.
	Current(average
	absolutevalue),
	mA, 500Ω
19	Maximum AveragePower Density,(mW/cm²),500Ω	1.8	2.88

Table 1: Substantial Equivalence Comparison Table

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Discussion:

The number of output modes, number of output channels, timer range, weight and dimension of the new device are different from the predicate devices, but the new devices are evaluated and passed the testing according to IEC 60601-1 and IEC 60601-2-10, this difference does not pose any new questions of safety.

The Max Output Voltage/Current, Pulse Duration, Maximum Phase Charge, Maximum Current Density and Maximum Average Power Density are similar with the predicate devices, but the new devices are evaluated and passed the testing according to IEC 60601-2-10, this difference doesn't pose any new questions of safety and effectiveness.

Performance Data: 6.

The following performance data are provided in support of the substantial equivalence determination:

6.1 Biocompatibility testing

The biocompatibility evaluation for the TC001 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". As dictated by the application and duration of contact with the intact skin, the testing included the following tests:

Cytotoxicity
Sensitization
Irritation

6.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the TC001. The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

For FCC part 15 RADIO FREQUENCY DEVICES, Subpart C—Intentional Radiators.

6.3 Software Verification and Validation Testing

Main device, Remote control and APP software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

6.4 Output waveform Testing

For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.

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7. Conclusions

The intended use and basic technological characteristics of the ThermaCare® Quick Therapy TENS are equivalent with those of the Predicate device K173462. Any technological differences do not raise new questions regarding safety and effectiveness.

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).