EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

• K Number: K163166
• Device Name: EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
• Manufacturer: EASYWELL BIOMEDICALS, INC.
• Date Cleared: 2017-08-11 ( 270 days)
• Product Code: NUH
• Regulation Number: 882.5890

Intended Use

The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities.

Device Description

The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies. The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery. The electrode patch is covered by polyester and nylon blended textile and can be connected to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat). The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. Thev comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization. The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2

Predicate Devices

K160115

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device appears to be a standard TENS unit with an optional heating function.

Therapeutic

Yes.
The device is used for the relief of pain associated with sore or aching muscles, which is a therapeutic purpose.

Diagnostic

No

The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) system intended for the relief of pain associated with sore or aching muscles, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a stimulator console, electrode patch, gel pads, and an AC/DC adaptor, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Function: The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It applies electrical stimulation to the skin to relieve pain. This is a physical therapy modality that acts on the body, not by analyzing samples from the body.
• Intended Use: The intended use is for the relief of pain associated with sore or aching muscles. This is a therapeutic application, not a diagnostic one.

The description clearly indicates that this device is used for pain relief through electrical stimulation and heat, which are external applications to the body. It does not involve the analysis of biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities.

Product codes

NUH

Device Description

The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies.

The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery.

The electrode patch is covered by polyester and nylon blended textile and can be connected to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat).

The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. They comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization.

The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-Counter (OTC)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing contained in this submission and clinical evaluation report supplied demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160115

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Easywell Biomedicals, Inc. Arthur Chen Quality Assurance Manager Suite 2, 2f, No.9, Jhanye 1 Rd. Hsinchu Science Park Hsinchu. TW

Re: K163166

Trade/Device Name: Easywell TENS System (TENS only), Easywell TENS System (TENS and Heat) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 11, 2017 Received: July 13, 2017

Dear Arthur Chen:

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. Iisting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

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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K163166 - 510(k) Summary

I. SUBMITTER

EASYWELL BIOMEDICALS INC. Suite 2, 2F, No.9, Jhanye 1st Rd., Hsinchu Science Park, 30078 Hsinchu, TAIWAN Phone:[phone] FAX: [phone] Contact Person: Richard Hsieh Date:Oct. 04, 2016

II. DEVICE

Trade/Device Name: Easywell TENS System (TENS only), Easywell TENS System (TENS and Heat) Common Name: Transcutaneous Electrical Nerve Stimulator (TENS) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulation Class: Class II Product Code: NUH

III. PREDICATE DEVICE

Omron: Heat Pain Pro (K160115 )

IV. DEVICE DESCRIPTION

The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies.

The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery.

The electrode patch is covered by polyester and nylon blended textile and can be connected

3

to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat).

The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. Thev comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization.

The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2

INTENDED USE V.

The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities.

VI. CONFORM STANDARDS

EASYWELL TENS System conforms to the following standard:

• 1. AAMI NS4: 2013 Transcutaneous electrical nerve stimulators
• 2. IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
• 3. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• 4. IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• 5. IEC 60601-2-10: 2012 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• 6. ISO 10993-1: 2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
• 7. ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• 8. ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
• 9. IEC 62304: 2006 Medical device software -- Software life cycle processes
• 10. EN/ISO 14971: 2012 Medical devices. Application of risk management to medical devices

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11. IEC/EN 62133:2013 Safety Test Standard of Li-Ion Cell and Battery

12. UN38.3 Testing-Safety Precautions for the Transportation of Lithium Batteries

VII. Similarities/Differences of the proposed candidate device when compared to the predicate

Omron Heat Pain Pro (K160115)

The subject EASYWELL TENS System is substantially equivalent to the predicate Heat Pain Pro (K160115) marketed by Omron Healthcare, Inc. with similar indications for use. The subject EASYWELL TENS System is intended for pain relief with sore or aching due to exercise or normal household work activities. The predicate Heat Pain Pro is intended for relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.

Both the subject EASYWELL TENS System and predicate Heat Pain Pro are available Over-the-Counter (OTC).

Both the subject EASYWELL TENS System and the predicate Heat Pain Pro have similar design specifications. Both use microprocessor technology to control the device and use Lithium-Ion battery as the power source. Both are rechargeable, can automatic shut off, and use the electrode patch with hydrogel.

Both the subject EASYWELL TENS System and the predicate Heat Pain Pro have similar output parameters. Both have 1 output channel. The subject EASYWELL TENS System provides TENS therapy on models EETTA00 and EETTL00, and, provides TENS therapy with heat on models EETTA01 and EETTL01; the predicate Heat Pain Pro provides TENS therapy and TENS therapy alternating heat. Both have similar heat temperature range, the subject EASYWELL TENS System conducts heat at maximum 41°C on models EETTA01 and EETTL01 and the predicate Heat Pain Pro conducts heat at maximum 43°C. Both have biphasic rectangular waveform shape. The subject EASYWELL TENS System has timer range 15 minutes and it's repeatable to extend the range, the predicate Heat Pain Pro has timer range 30 minutes.

The subject EASYWELL TENS System and the predicate Heat Pain Pro comply with the same standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 and IEC 60601-2-10. The subject EASYWELL TENS System also complies with AMMI NS4.

The similarities between the subject EASYWELL TENS System and the predicate Heat Pain Pro are compared in table 1.

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Feature	Subject	Predicate
510(k) Number	-	K160115
Manufacturer	EASYWELL Biomedicals, Inc.	Omron
Healthcare, Inc.
Trade Name	EASYWELL TENS System	Omron Heat
Pain Pro
Model Name	EETTA00
EETTL00
(TENS Only)	EETTA01
EETTL01
(TENS and Heat)	PM311
Indications for Use	The EASYWELL TENS System is
intended for:
The relief of pain associated with sore or
aching muscles due to strain from
exercise or normal household work
activities.	The Omron
Heat Pain Pro is
intended for:
The relief of
pain associated
with sore or
aching, muscles
of the lower
back, arms, legs,
shoulder, or foot
due to strain
from exercise or
normal
household work
activities.
Type of Use	Over-the-Counter (OTC)	Over-the-Count
er (OTC)
Design
Specification	Controller	Microprocessor	Microprocessor
	Power Source	Lithium-Ion battery	Lithium-Ion
battery
	Rechargeable	Yes	Yes
	Automatic Shut Off	Yes	Yes
	Electrode Patch/
Gel Pad	Electrode Patch with Hydrogel	Electrode Patch
with Hydrogel
Output
Parameter	Number of output
channels	1 Channel	1 Channel
	Output Modes	TENS Therapy
only	TENS Therapy with
HEAT
	Heat Temperature	N.A.	41°C Maximum
	Waveform Shape	Biphasic Rectangular	Biphasic
Rectangular
	Timer Range	15 minutes	30 minutes
Compliance with Standards	IEC60601-1
IEC60601-1-2	IEC60601-1
IEC60601-1-2
			IEC 60601-1-11
IEC60601-2-10
AAMI NS4	IEC 60601-1-11
IEC60601-2-10
Performance
and
Specifications	Max.
Output
Voltage	@500Ω	58.8V	67.2V
		@2KΩ	94V	86.0V
		@10KΩ	119V	95.9V
	Max.
Output
Current	@500Ω	117.6mA	134.2mA
		@2KΩ	45.5mA	45.0mA
		@10KΩ	11.9mA	9.6mA
	Duration of primary phase		132μs	32μs
	Pulse Duration@500Ω		220μs	96μs
	Frequency		2.2 to 34.7Hz	1 to 99Hz
	Net Charge @500Ω (per pulse)		0μC	0μC
	Maximum Phase Charge @500Ω		15.5μC	4.3μC
	Active Surface Area for each Electrode (cm²)		1) EW-P000-G Standard 30

2. EW-P000-L Lower Back 60 | 25 |
   | | | | | |
   | | Maximum Current for each Electrode @500Ω(mA) | | 1) EW-P000-G Standard 117.6
3. EW-P000-L Lower Back 117.6 | 134.2 |
   | | | | | |
   | | Maximum Charge Density for each Electrode @500Ω (mA/cm²) | | 1) EW-P000-G Standard 3.92
4. EW-P000-L Lower Back 1.96 | 5.38 |
   | | | | | |
   | | | | | |
   | | Maximum Power Density for each Electrode @500Ω (mW/cm²) | | 1) EW-P000-G Standard 230.5
5. EW-P000-L Lower Back 115.2 | 361.3 |
   | | | | | |

Table 1 Comparison with the predicate Heat Pain Pro (K160115)

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Substantial Equivalence:

EASYWELL TENS System has the same intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission and clinical evaluation report supplied demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the EASYWELL TENS System is substantially equivalent to the predicate devices.

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