This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

Device Description

SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.

There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd.

A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.

There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the SmartTENS device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the SmartTENS in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity) expected from a clinical study. Instead, it details the technical specifications and performance characteristics of the SmartTENS and compares them to predicate devices, demonstrating substantial equivalence.

The reported device performance is implicitly shown through its compliance with various electrical and medical device safety standards and a usability study.

Attribute/Criteria Type	Acceptance Criteria (Implied / Comparator)	Reported Device Performance (SmartTENS)
Indications for Use	Relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities (Same as Predicate 1, similar to Predicate 2 but broader for SmartTENS).	Intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Product Code	NUH (Predicate 1), GZJ, NYN (Predicate 2)	NUH
Regulation No.	21 CFR 882.5890	21 CFR 882.5890
Wireless Control	No (Predicate 1), Yes (Predicate 2)	Yes (Bluetooth 4.0)
Number of Output Modes	8 (Predicate 1), 4 (Predicate 2)	7
Number of Output Channels	2 (Predicate 1), 1 (Predicate 2)	1
Waveform	Biphasic rectangular, Monophasic rectangular (Predicate 1), Pulsed biphasic rectangular (Predicate 2)	Biphasic rectangular, Monophasic rectangular
Maximum Output Voltage (500Ω)	68V (Predicate 1), 35.2 V (Predicate 2)	68V
Maximum Output Current (500Ω)	133mA (Predicate 1), 70mA (Predicate 2)	133mA
Maximum Phase Charge (500Ω)	20.02µC (Predicate 1), 11.6µC (Predicate 2)	20.02µC
Maximum Average Current (500Ω)	3.0375mA (Predicate 1), 0.63mA (Predicate 2)	3.0375mA
Maximum Current Density (500Ω)	0.188mA/cm² (Predicate 1), 0.00149 mA/cm² (Predicate 2)	0.066mA/cm²
Maximum Average Power Density (500Ω)	7.52mW/cm² (Predicate 1), 0.0313mW/cm² (Predicate 2)	2.66mW/cm²
Frequency (Hz)	From 1Hz to 150Hz (Predicate 1), From 5Hz to 120Hz (Predicate 2)	From 1Hz to 150Hz
Pulse Duration (µs)	50-250µs (Predicate 1), 120-250µs (Predicate 2)	50-250µs
Burst Mode	Yes (Predicate 1), No (Predicate 2)	Yes
Timer Range (min)	20min, 25min, 30min, 40min (Predicate 1), 30min (Predicate 2)	20min, 25min, 30min, 40min depending on preset program
Power Source	2 Alkaline AA 1.5V (Predicate 1), 2 Alkaline AAA 1.5V DC + 1 CR2032 Lithium (Predicate 2)	3.7V rechargeable lithium battery
Microprocessor Control	Yes	Yes
Automatic Overload Trip	Yes (Predicate 1), No (Predicate 2)	Yes
Automatic No-load Trip	Yes (Predicate 1), No (Predicate 2)	Yes
Automatic Shut-off	Yes	Yes
User Override Control	Yes	Yes
Indicator Display (On/Off, Low Battery, Voltage/Current Level, Output Mode, Time to cut-off)	Yes for all (Predicate 1), Yes for On/Off & Low Battery (Predicate 2)	Yes for all
Electrode Compliance with 21 CFR 898	Yes	Yes
Usability	Users able to use device correctly and safely.	Usability study showed users were able to use the device correctly and safely.
Electrical Safety	Compliance with AAMI/ANSI ES60601-1:2005/(R)2012	Complies with AAMI/ANSI ES60601-1:2005/(R)2012
EMC	Compliance with AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 and IEC 60601-1-11	Complies with AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 and IEC 60601-1-11
Nerve & Muscle Stimulator Specific Safety	Compliance with IEC 60601-2-10 Edition 2.0 2012-06	Complies with IEC 60601-2-10 Edition 2.0 2012-06
Risk Management	Compliance with ISO 14971: Second Edition 2007-03-01	Complies with ISO 14971: Second Edition 2007-03-01
Usability Engineering	Compliance with IEC 60601-1-6 Edition 3.0 2010-01	Complies with IEC 60601-1-6 Edition 3.0 2010-01
Software Life Cycle Processes	Compliance with IEC 62304 First Edition 2006-05	Complies with IEC 62304 First Edition 2006-05

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

The document mentions that a "usability study was conducted," but it does not specify the sample size for this study or any other test set. The data provenance (country of origin, retrospective/prospective) for any test data is also not mentioned.

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

This information is not provided in the document. The usability study would likely have involved user feedback, but the "ground truth" for a medical device's performance often relates to objective measures of efficacy or safety, which are not detailed here in terms of expert evaluation.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted for this device as it is a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.) which directly delivers electrical current, rather than an imaging or diagnostic AI requiring human reader interpretation. The purpose of this submission is to demonstrate substantial equivalence to predicate devices based on technical specifications and safety standards, not a comparative effectiveness study involving human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The SmartTENS is a physical medical device, not an algorithm in the context of AI. Therefore, a standalone (algorithm only) performance study as typically understood for AI/software devices was not performed or is not applicable. Its performance is assessed through its output characteristics and compliance with electrical and safety standards.

7. Type of Ground Truth Used

For the SmartTENS, the "ground truth" for its performance is established through:

Compliance with recognized electrical and medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, IEC 62304). This demonstrates that the device operates within established safe and effective parameters for TENS devices.
Usability Feedback: The usability study inherently uses user experience (ease of use, safety observation) as a form of "ground truth" to determine if users can correctly and safely operate the device.

8. Sample Size for the Training Set

The SmartTENS is a hardware device with embedded software (for control and modes), but not an AI/machine learning model in the sense that would require a "training set" of data for learning and prediction. Therefore, a training set sample size is not applicable and not mentioned.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/machine learning model, this question is not applicable. The "ground truth" for the device's design and functionality is based on established engineering principles, regulatory standards, and the performance characteristics of predicate devices.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are arranged in a way that they appear to be connected. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 29, 2015

Easymed Instruments Co., Ltd Mr. Jeffery Wu (Wu Tingjie) General Manager 5/F - 6/F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, CHINA

Re: K143430

Trade/Device Name: SmartTENS Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: April 30, 2015 Received: May 4, 2015

Dear Mr. Tingjie Wu:

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 Aquel -S

Carlos L. Peña, PhD, MS 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) K143430

Device Name SmartTENS

Indications for Use (Describe)

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

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

Registration under Part 21 CFR 601 Subpart E
Request for Exception under 21 CFR 601 Subpart G

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the Easymed logo. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".

510(k) Summary

Date of submission prepared: October 6, 2014

Submitter:	EasyMed Instruments Co., Ltd.
Address:	5/F – 6/F, Block A, Gupo Gongmao Building, Fengxin Road,Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan,Guangdong, CHINA
Tel:	+86 757 2809 1300
Fax:	+86 757 2772 7868
E-Mail:	jeffery@easymed.com.cn

Official Contact: Jeffery Wu (Wu Tingjie)
Address of the manufacturing facility: The same as above

SUBMITTED DEVICE:

Generic Name:	Transcutaneous Electrical Nerve Stimulator (T.E.N.S.)
Proprietary or Trade Name:	SmartTENS
Common/Usual Name:	Stimulator, nerve, transcutaneous, over-the-counter
Classification Name:	Stimulator, nerve, transcutaneous, over-the-counter21 CFR 882.5890
Product Code:	NUH
Device Panel:	Neurology
Device Classification:	Class II

PREDICATE DEVICES:

Device Name:	EasyStim TN28_OTC
Manufacturer:	EasyMed Instruments Co., Ltd.
510(k) Number:	K140168
Product Code:	NUH

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Image /page/4/Picture/0 description: The image shows the Easymed logo. The word "Easymed" is written in a large, bold, blue font. There is a red line underneath the word "Easymed". Below the red line, the words "Easy for the relief of your suffering" are written in a smaller, black font. There is a registered trademark symbol to the right of the word "Easymed".

WiTouch™ Pro Device Name: Manufacturer: Hollywog, LLC 510(k) Number: K120398 Product Code: GZJ. NYN

INDICATIONS FOR USE:

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

DEVICE DESCRIPTION:

SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.

A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.

Accessories:

M-CBX-C-008	Button-affixed Electrode
P-AE-002-A	Replaceable Hydrogel Pads (gel-pads) 73mm x 62mm
	for external use. Pack of 2*
CBX-057-B	Charger Cradle
M-PA-004-B	Charging Adaptor

The accessories include an electrode and two hydrogel pads (gel-pads). The electrode is connected to the device by snapping the two buttons onto the device. One side of the adhesive gel-pads adheres to the electrode, and the other side adhere the device to the healthy intact skin of the user's body. Generally, the device produces either a fixed or modulated electrical signal through electrodes normally placed over the area of pain.

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Image /page/5/Picture/0 description: The image shows the logo for Easymed. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".

EasyMed Instruments Co., Ltd.

A built in Li-Ion battery is the power source of the device, which can be recharged for a limited large number of times. To charge the device, remove the electrode assembly by unsnapping it off the device, place the device on the charger cradle, insert the small pin of the charging adaptor into the charge cradle, and connect the charging adaptor to the electrical power supply.

Smart Phone Hardware Requirement:

1. iPhone 4s or later models, or iPad 3 or later models, with iOS 6.0 or better system. Or,
1. Smart phone or Tablet supporting BT 4.0 BLE feature with Android 4.3 or better system.

As above, the device is battery powered; there is no connection to AC mains supply.

ENVIRONMENT OF USE: Clinics, hospital and home environments

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Image /page/6/Picture/0 description: The image shows the brand name "Easymed" in a large, bold, blue font. Below the brand name, there is a thin red line. Underneath the line, the text "Easy for the relief of your suffering" is written in a smaller, blue font.

SUMMARY OF SUBSTANTIAL EQUIVALENCE

Attribute	New Device	Predicate Device (1)	Predicate Device (2)
Product Name	SmartTENS	EasyStim TN28_OTC	WiTouch™ Pro
510(K) number	K143430	K140168	K120398
Product Code	NUH	NUH	GZJ, NYN
Regulation No.	21 CFR 882.5890	21 CFR 882.5890	CFR Title 21, 882.5890
Indications for Use	This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.	This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.	This device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treament fro post-surgical and post-trauma acute back pain.
Patient Population	Adult	Adult	Not specified
Prescriptive or OTC	OTC	OTC	Prescription
Wireless Control	Yes	No	Yes
Number of output modes	7	8	4
Number of output channels	1	2	1
Waveform	Biphasic rectangularMonophasic rectangular	Biphasic rectangularMonophasic rectangular	Plused biphasic rectangular
Maximum Output Voltage(max)
500 ohm	68V @500Ω	68V @500Ω	35.2 V @500Ω
2k ohm	102V @ 2 kΩ	102V @ 2 kΩ	52V @ 2 kΩ
10k ohm	110V @10 kΩ	110V @10 kΩ	60.8V @10 kΩ
Maximum Output Current(max)
500 ohm	133mA	133mA	70mA @500Ω
2k ohm	51mA	51mA	26mA @ 2 kΩ
10k ohm	11mA	11mA	6mA @10 kΩ
Maximum Phase	20.02µC	20.02µC	11.6µC
charge (500 ohm)
Maximum AverageCurrent (500 ohm)	3.0375mA	3.0375mA	0.63mA
Maximum CurrentDensity (500 ohm)	0.066mA/cm²	0.188mA/cm²	0.00149 mA/cm²
Maximum AveragePower Density(500 ohm)	2.66mW/ cm²	7.52mW/ cm²	0.0313mW/cm²
Frequency (Hz)	From 1Hz to 150Hz	From 1Hz to 150Hz	From 5Hz to 120Hz
Pulse Duration (us)	50-250μs	50-250μs	120-250μs,
Burst Mode	Yes	Yes	No
Timer range(min)	20min, 25min, 30min, 40min depending on preset program	20min, 25min, 30min, 40min depending on preset program	30min
Power Source	3.7V rechargeable lithium battery	2 Alkaline AA 1.5V (LR6) Batteries	2 Alkaline AAA 1.5V DC Batteries1 CR2032 Lithium battery (Internal Power)
Dimensions (mm)	155.4 x 64.6 x 19.1	66×136×30.7	18 x 191 x 90
Weight	64g	146.5 grams	4.8 oz
Housing material	TPE & ABS	ABS	Silicone & ABS
Microprocessorcontrol	Yes	Yes	Yes
AutomaticOverload trip	Yes	Yes	No
Automatic no-loadtrip	Yes	Yes	No
Automatic shut-off	Yes	Yes	Yes
User overridecontrol	Yes	Yes	Yes
Indicator Display:- On/Off Status?- Low Battery?- Voltage/Current Level?-Output mode-Time to cut-off	YesYesYesYesYes	YesYesYesYesYes	YesYesNoNoNo
Electrodecompliance with 21CFR 898	Yes	Yes	Yes
Electrode cable	No	Yes	No

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Image /page/7/Picture/0 description: The image shows the Easymed logo. The logo is in blue and has a registered trademark symbol next to it. Underneath the logo is a red line.

Easy for the relief of your suffering

EasyMed Instruments Co., Ltd.

Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China Fax: 86-757-27727868 Tel: 86-757-28091300

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Image /page/8/Picture/0 description: The image contains the logo for Easymed. The logo is in blue and has a registered trademark symbol next to it. Below the logo is a red line, and below that is the text "Easy for the relief of your suffering".

DIFFERENCES BETWEEN NEW DEVICE AND PREDICATE DEVICES

The technical characteristics of SmartTENS are similar to those of the predicate devices in design, intended use and function. Like the predicate device EasyStim TN28 OTC (K140168) and WiTouch™ Pro (K120398), the SmartTENS is a device used to apply an electrical current to electrodes on a patient's skin to relieve pain. The stimulation parameters of new device EasyStim TN28 OTC are same as those of predicate device EasyStim TN28 OTC (K140168) and similar to those of WiTouch™ Pro (K120398).

The predicate device EasyStim TN28_OTC (K140168) utilizes flexible wires between the electrodes and the electical stimulus generator. However, the new device SmartTENS utilize wireless remote controls for the considerations of a more user friendly design, which is similar to WiTouch™ Pro (K120398).

The intended design of SmartTENS limits the application for use to sites of lower back, arms and legs. The design includes Thermal Plastic Elastomer (TPE) electrodes that are intended for reuse and are button-affixed to the electrical stimulus generator. The unique connection makes the electrodes integral to the generator. The connection and shape of the electrodes limit application of the device. These unique characteristics of the integral electrodes are similar to those of WiTouch™ Pro (K120398) and insignificant as it relates to safety and effectiveness, which is not critical to the intended use between the referenced predicate devices.

The predicate device EasyStim TN28 OTC (K140168) utilizes affixed buttons as the sole method to control the electrical stimulus generator. The new device SmartTENS utilizes an additional method of a wireless remote control which similar to the predicate device WiTouch™ Pro (K120398). The difference is WiTouch™ Pro (K120398) utilizes radio frequency transveiver to control the electrical stimulus generator, while the SmartTENS ultilzes Bluetooth 4.0 as the wireless connecting technology to control the electrical stimulus generator. Furthermore, the remote controller is the Mobile Medical Application that need to be installed in the smart phone. This uniqueness of controlling the electrical stimulus generator by utilizing a Bluetooth wireless connecting technology is insignificant as it relates to safety and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices.

Technological characteristics, features, specifications and intended uses of the new device SmartTENS are substantially equivalent to the referenced predicate devices. The differences that exist between SmartTENS and predicate devices are insignificant in the terms of safety or effectiveness.

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PERFORMANCE TESTS

FDA recognition No.	Standard Title
19-5	AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012And A2:2010/(R)2012 (Consolidated Text) Medical ElectricalEquipment - Part 1: General Requirements For Basic Safety AndEssential Performance (IEC 60601-1:2005, Mod). (General I (QS/RM))
19-2	AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, Medical ElectricalEquipment - Part 1-2: General Requirements For Basic Safety AndEssential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3). (General II (ES/EMC))
19-6	IEC 60601-1-11 Edition 1.0 2010-04, Medical Electrical Equipment -Part 1-11: General Requirements For Basic Safety And EssentialPerformance - Collateral Standard: Requirements For MedicalElectrical Equipment And Medical Electrical Systems Used In TheHome Healthcare Environment [Including: Technical Corrigendum 1(2011)]. (General II (ES/EMC))
17-11	IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment --Part 2-10: Particular Requirements For The Basic Safety And EssentialPerformance Of Nerve And Muscle Stimulators. (Neurology)
5-40	ISO 14971: Second Edition 2007-03-01 Medical devices- Application ofRisk Management To Medical Devices. (General I (QS/RM))
5-85	IEC 60601-1-6 Edition 3.0 2010-01, Medical Electrical Equipment-Part1-6: General Requirements For Basic Safety and EssentialPerformance- Collateral Standard: Usability(General I (QS/RM))
13-8	IEC 62304 First Edition 2006-05, Medical devices software- Softwarelife cycle processes (Software/ Informatics)

USABILITY STUDY:

A usability study was conducted and showed that users were able to use the device correctly and safety.

Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China Tel:

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Image /page/10/Picture/0 description: The image shows the logo for Easymed. The logo is in blue and has a red line underneath it. Below the red line is the text "Easy for the relief of your suffering".

CONCLUSION:

The new device SmartTENS has the same indications for use and similar technological characteristics to the predicate device EasyStim TN28 OTC (K140168) and WiTouch™ Pro (K120398). The stimulation parameters of new device SmartTENS are all in the same range of those of predicate devices. Thus, the new device SmartTENS is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of 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).