The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

They can be used on body parts such as arm and elbow.

Device Description

Well-Life Garment Electrodes (GM, Series), Models AM and EB, are intended to be used with legally Marketed Transcutaneous Electrical Nerve Stimulation (TENS) devices which could be used in place of traditional cutaneous electrode patches. The Well-Life Garment Electrodes (GM Series) are blended with Nonconductive textiles (polyurethane, nylon and polyester) and conductive textiles (Silver Fabric). Non-conductive area is used to fix and support Well-Life Garment Electrodes (GM Series) on the body. Two types of Garment Electrodes are designed.

The different series of model means different placement of the garment electrode. For "AM" it is to be place around the arm with conductive areas are on the upper arm and lower arm and there are two sets of snap facing outward, finally for "EB" it is to be place around the elbow with conductive area surrounds the elbow and there are one sets of snap facing outward. There are three sizes for each series of model (S/M/L). The conductive area between different sizes is fixed. There is four conductive area divided into upper arm area and lower arm area on model "AM", the areas is a pair of 39 cm² and a pair of 39 cm². There is only two conductive area on model "EB", the areas is a pair of 25.5 cm2.

By adjusting the area of the non-conductive area, the customer's body curve can be fitted. Conductive area is used as a transmission interface which enabling electrical stimulation devices to transmit signals to the skin. The devices must be used wet when in contact with the skin. When using Well-Life Garment Electrodes (GM Series), buckle the one port of lead wire or any connection terminal from legally marketed stimulator to the set of closest snap buttons on Garment Electrodes. Make sure electrical signals could reach the path from electrical stimulation to the Garment Electrodes.

For Garment Electrodes with multiple sets of buttons, only one set of buttons can be used at a time. The surface of conductive area has a resistance of less than 14 ohms per inch. The signal is generated by an electrical stimulator, and is transmitted evenly through the wire to the conductive area of the Garment Electrodes, and transmitted to the skin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Well-Life Garment Electrodes (GM Series) based on the provided FDA 510(k) summary:

This device is an electrode, specifically a cutaneous electrode, and not an AI/ML powered device. Therefore, a significant portion of the requested information (such as AI-specific components like training/test sets, ground truth methodology involving experts, MRMC studies, or standalone algorithm performance) is not applicable to this submission. The "study" here refers to non-clinical testing to demonstrate performance and safety, primarily through bench testing and biocompatibility assessments, rather than clinical trials with human readers or AI performance metrics.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established standards for medical devices, particularly those related to biocompatibility and electrical safety/performance of electrodes. The reported performance demonstrates compliance with these standards.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -12 (Evaluation and testing within a risk management process, cytotoxicity, irritation and skin sensitization, sample preparation)	Patient-contacting components are in compliance with ISO 10993 requirements, confirmed by testing for cytotoxicity, sensitization, and irritation.
Electrical Safety & Performance	Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)	Bench testing performed to verify performance to specifications. The device meets the basic safety and essential performance requirements of nerve and muscle stimulators as per IEC 60601-2-10.
Impedance Distribution Uniformity	Uniform and safe impedance within specification, preventing "hot spots" leading to user discomfort or burns.	Testing confirmed uniform impedance distribution, preventing "hot spots." The conductive area has a resistance of less than 14 ohms per inch. (Note: This is an internal specification based on safety, compared to predicates of 2 and 7 ohms/inch).
Shelf Life	Compliance with ASTM F1980 (Accelerated Aging)	Accelerated Aging Testing (ASTM F1980:2016) was performed to demonstrate shelf life.
Reusability	Ability to withstand maximum duration, maximum number of uses, and maximum number of re-washes (In-house specification).	Reusability testing was performed (duration, number of uses, and re-washes) according to in-house specifications. The device is washable and reusable for a single patient.
Maximum Average Current Density	Not explicitly stated as an AC, but safety demonstrated by values.	0.254 mA/cm² (arm) and 0.392 mA/cm² (elbow) at 500 Ω. These values are considered within safe limits, referencing "IEC60601-2-10 Clause 201.4.2" for comparison.
Maximum Peak Power Density	Not explicitly stated as an AC, but safety demonstrated by values.	1.255 mW/cm² (arm) and 1.958 mW/cm² (elbow) at 500 Ω. These values are considered within safe limits, referencing "Guidance Document for Powered Muscle Stimulator 510K Section 3" for comparison.

Specific Information Requested (and applicability to this device):

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as individual "test sets" in the context of clinical data. For bench testing of physical characteristics, samples of the device (GM Series electrodes) were tested in a laboratory setting. For biocompatibility, samples of the patient-contacting materials were tested.
- Data Provenance: All data appears to be prospective laboratory and bench testing conducted specifically for this 510(k) submission, following recognized standards. The country of origin for the testing is not specified but the submitter is Well-Life Healthcare Ltd. in New Taipei City, Taiwan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware medical device (cutaneous electrode) and not an AI/ML powered device requiring interpretation of medical images or other data by experts to establish ground truth for a test set. Ground truth here is defined by physical and electrical properties measured objectively in a lab.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a clinical study involving subjective interpretation or diagnostic accuracy where adjudication among experts would be needed. Bench testing and biocompatibility follow objective, standardized protocols.
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 is not an AI-powered diagnostic device, so MRMC studies, human reader improvement with AI assistance, and effect sizes are irrelevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device contains no "algorithm" to be tested in a standalone fashion. It is a passive conductive garment electrode.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance and safety is established through:
  - Objective measurements and physical properties: e.g., impedance readings, current density, power density, material composition.
  - Standardized test methods: defined by ISO, IEC, and ASTM, which specify how to measure parameters and what constitutes acceptable performance/safety.
  - Biocompatibility test results: conforming to ISO 10993 series.
The sample size for the training set:
- Not Applicable. This device does not use an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of the Study:

The "study" for the Well-Life Garment Electrodes (GM Series) consisted of a series of non-clinical tests to demonstrate that the device meets established safety and performance standards for cutaneous electrodes. These tests include:

Biocompatibility testing: Performed according to ISO 10993 series, confirming that the materials in contact with the patient's skin are safe (no cytotoxicity, sensitization, or irritation).
Electrical performance and safety testing: Including compliance with IEC 60601-2-10 for nerve and muscle stimulators, impedance distribution uniformity testing to prevent "hot spots," and measurements of maximum average current density and maximum peak power density.
Shelf life testing: Conducted via accelerated aging (ASTM F1980) to determine the product's stability over time.
Reusability testing: To ensure the device maintains its performance after multiple uses and washes for a single patient, per in-house specifications.

The results of these tests were used to demonstrate substantial equivalence to legally marketed predicate devices, particularly in areas of intended use, principle of operation, and overall safety and performance profiles. The differences noted (e.g., specific impedance values, exact design/size) were evaluated and determined not to raise new questions of safety or effectiveness.

Summary

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June 1, 2021

Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No, 168, Lide St., Jhonghe District New Taipei City, 235 Taiwan

Re: K200942

Trade/Device Name: Well-Life Garment Electrodes (GM Series) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: April 23, 2021 Received: April 30, 2021

Dear Ms. Hsieh:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200942

Device Name Well-Life Garment Electrodes (GM Series)

Indications for Use (Describe)

The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices.

The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

They can be used on body parts such as arm and elbow.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING." The logo features a stylized yellow butterfly shape, with the text "well-life" superimposed on the butterfly's wing. The tagline is written in smaller font below the main text.

510(K) Summary

1. Type of Submission:	Traditional 510(k)
2. Preparation date:	13th May, 2021
3. Submitter:	Well-Life Healthcare Ltd.
Address:	6F. No.168, Lide St., Jhonghe DistrictNew Taipei City, 23512, Taiwan
Phone:	+886-2-22266981
Fax:	+886-2-22266965
Contact:	Jenny Hsieh(jenny@welllifehealthcare.com.tw)
Registration number:	3006850006

1. Identification of the device:

Device Name:	Well-Life Garment Electrodes (GM Series)
Common or usual name:	Garment Electrode
Classification name:	Electrode, Cutaneous
Device Models:
(RX)
	Well-Life Garment Electrode – Arm (GM-AM-R-X00)
	Well-Life Garment Electrode – Elbow (GM-EB-R-X00)
(OTC)
	Well-Life Garment Electrode – Arm (GM-AM-O-X00)
	Well-Life Garment Electrode – Elbow (GM-EB-O-X00)

Classification Panel:	Neuromodulation and Physical Medicine Devices
Device Classification:	II
Regulation Number:	882.1320
Panel:	Neurology
Product Code:	GXY

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Image /page/4/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text superimposed on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font.

5. Identification of the Predicate Device:
Predicate Device Name:	Theraknit Garment
Manufacture:	Neurotron Medical, Inc
Regulation Number:	882.1320
Product Code:	GXY
510(k) Number:	K053214
Predicate Device Name:	Electrodes with Silver Conductive
Manufacture:	Shenzhen Konmed Technology Co
Regulation Number:	882.1320
Product Code:	GXY
510(k) Number:	K171721

6. Intended Use and Indications for use of the Subject Device:

The Well Life Garment Electrodes (GM Series) are intended to be used with legally marketed TENS devices.

The Well-Life Garment Electrodes (GM Series) will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

They can be used on body parts such as arm and elbow.

7. Description of the Device:

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Image /page/5/Picture/1 description: The image shows a logo for a company called "well-life". The logo features a stylized butterfly shape in yellow, with the company name overlaid on the butterfly's wing. Below the company name, there is a tagline that reads "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller letters. The overall design is clean and modern, suggesting a focus on health and well-being.

there are one sets of snap facing outward. There are three sizes for each series of model (S/M/L). The conductive area between different sizes is fixed. There is four conductive area divided into upper arm area and lower arm area on model "AM", the areas is a pair of 39 cm² and a pair of 39 cm². There is only two conductive area on model "EB", the areas is a pair of 25.5 cm2.

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K200942

Image /page/6/Picture/1 description: The image shows the logo for Well-Life, a healthcare company. The logo features a yellow butterfly with the company name "well-life" in blue letters. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, black letters. The butterfly and text are positioned to create a visually appealing and recognizable brand identity.

Well-Life Healthcare Limited

8. Statement of conformity

List of FDA-recognized voluntary consensus standards cited in this submission.

RecognitionNumber	Standard DesignationNumber And Date	Title Of Standard	Date OfRecognition
2-258	ISO 10993-1 Fifth Edition2018-08	Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess	01/14/2019
2-245	ISO 10993-5 Third Edition2009-06-01	Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity	02/23/2016
2-174	ISO 10993-10 Third Edition2010-08-01	Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization	07/26/2016
2-191	ISO 10993-12 Fourth Edition2012-07-01	Biological evaluation of medical devices - Part 12:Sample preparation and reference materials	07/26/2016
17-16	IEC 60601-2-10 Edition 2.12016-04	Medical electrical equipment - Part 2-10:Particular requirements for the basic safety andessential performance of nerve and musclestimulators	06/27/2016
5-125	ISO 14971 Third Edition 2019-12	Medical devices - Application of risk managementto medical devices	12/23/2019

9.Non-Clinical Testing Summary:

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

1. Biocompatibility Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5 Third Edition 2009-06-01), sensitization (ISO 10993-10 Third Edition 2010-08-01), irritation (ISO 10993-10 Third Edition 2010-08-01) and Sample preparation and reference materials (ISO 10993-12 Fourth Edition 2012-07-01)
1. Performance Bench testing was performed to verify the performance to specifications of the proposed device and included the following:
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04)
- Impedance Distribution Uniformity Testing is for verifying the conductive properties of subject device. Uniform and safety shall be within the specification, so that there aren't any "hot spots" that may result in user discomfort or burns.
- Shelf Life (Accelerated Aging) Testing (ASTM F1980:2016)
- Reusability of the maximum duration, of the maximum number of times and of the maximum number of re-wash (In-house specification)

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Image /page/7/Picture/1 description: The image shows the logo for Well Life. The logo features a yellow butterfly with the words "well life" written in blue on the butterfly's wing. Below the words "well life" are the words "Smarter Healthcare Products for Better Living" in a smaller font.

10. Substantial Equivalence Determination:

10.1 Substantial Equivalence Comparison to Predicate Device

Elements of Comparison	Subject Device	Primary Predicate	Secondary Predicate	Remark
Company	Well-Life Healthcare Ltd	Neurotron Medical , Inc.	Shenzhen Konmed Technology Co	--
Device Name	Well-Life Garment Electrodes(GM series)	TheraKnit Garment Electrode	Electrodes with silver conductive	--
Regulation Number	882.132	882.132	882.132	Same
Product K Number	Applying	K053214	K171721	--
Product code	GXY	GXY	GXY	Same
OTC/Rx	OTC/Rx	Rx	OTC	Similar
Intended Use/Indication for use	The Well Life Garment Electrodes	The TheraKnit Garment electrodes	Electrodes with silver conductive	Similar
	(GM Series) are intended to beused with legally marketed TENSdevices.	are cutaneous to be used withlegally tens Stimulating device.	as glove style, socks style,wristbands style, wrist sleeve,elbow pads style and knee padsstyle, elbow sleeve, are intendedfor use with legally marketedTENS stimulating device. Theelectrodes with silver conductivewill deliver stimulation signalsgenerated by the stimulator to thebody surface with which they arein contact.These body parts can include suchas hands (gloves), feet (socks)wrist, elbow and knee.	(Note.1)
	The Well-Life Garment Electrodes(GM Series) will deliver thestimulation signals generated bythe stimulator to the body surfacewith which they are in contact.	The knitted garment electrodes willdeliver the stimulation signalsgenerated by the stimulator to thebody surface with which they arein contact. These body parts canincluded hand(glove), feet (socks),elbow or knee (sleeve),arm, leg,shoulder, back(pads)
	They can be used on body partssuch as arm and elbow.
Design (Shape)/ Model	GM-AM-R-X00 / GM-AM-O-X00Arm RX/OTCGM-EB-R-X00 / GM-EB-O-X00Elbow RX/OTC	Electrode A: Glove StyleElectrode B: Socks StyleElectrode C: Sleeve StyleElectrode D: Pads Style	KM-406: Glove StyleKM-407: Socks StyleKM-408: Wristbands StyleKM-409: Elbow pads StyleKM-410:Knee Pads Style	Similar(Note.2)
Size	Arm (S/M/L)Elbow (S/M/L)	All sizes	One size below is size for whenwithout stretched:KM-406: 200(cm²)KM-407: 285(cm²)KM-408: 95 (cm²)KM-409: 160(cm²)KM-410: 236(cm²)	Similar(Note.2)
Anatomical locations of use				Similar
	ArmElbow	HandsFeetElbowKneeArmLegShoulderBack	HandsFeetWristElbowKnee	(Note.2)
Impedance Parameters	14 ohms resistance per inch	7 ohms resistance per inch	2 ohms resistance per inch	Similar(Note.2)
Biocompatibility	Complying with ISO 10993requirements	Complying with ISO 10993requirements	Complying with ISO 10993requirements	Same(Note.2)
Power Source	legally Marketed ElectricalStimulator	legally Marketed ElectricalStimulator	legally Marketed ElectricalStimulator	Same
Maximum Average Current Density(@500 Ω)	0.254 mA/cm² (arm)0.392 mA/cm² (elbow)	not publicly available	not publicly available
Maximum Peak Power Density(@500 Ω)	1.255 mW/cm² (arm)1.958 mW/cm² (elbow)	not publicly available	not publicly available
Washable or not	Washable	Washable	Washable	Similar(Note.3)
Re-usable	For single Patient	For single Patient	For single Patient	Same
Conductive surface area	Arm:Area 1: 39.00 cm²Area 2: 39.00 cm²Elbow:Area 1: 25.50 cm²	Not publicly available	One sizeBelow is size for when withoutstretched:KM-406: 400 (cm²)KM-407: 570 (cm²)KM-408: 190 (cm²)KM-409: 320 (cm²)KM-410: 472 (cm²)
Patient contacting material	Non-conductive textiles(polyurethane, nylon and polyester)and conductive textiles (SilverFabric)	Silver plated nylon	Silver plated nylon

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Image /page/8/Picture/1 description: The image shows a logo for "well-life". The logo features a yellow butterfly with the text "well-life" in blue on top of the butterfly. Below the text, there is a tagline that reads "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller blue letters.

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Image /page/9/Picture/1 description: The image shows the logo for Well Life. The logo features the words "well life" in blue font. Below the words is the phrase "Smarter Healthcare Products for Better Living" in a smaller font. The words are superimposed on a yellow butterfly.

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Image /page/10/Picture/1 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text over the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, black text.

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Image /page/11/Picture/1 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, red text.

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Image /page/12/Picture/1 description: The image shows the logo for Well-life. The logo features a yellow butterfly shape with the words "well-life" in blue text across the center. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, yellow font.

Comparison in Detail(s):

Note 1: The description are partially different among Subject Device, Primary Predicate Devices, and secondary Predicate Devices but the Intended Use/ Indication for use are similar. They are all used to deliver the stimulation signals generated by electrical stimulator to the body surface.

Note 2: Electrode conductive area and Impedance Parameters

Although the subject device has 14 ohms per inch. which is different from the predicate device, "Maximum Average Current Density" and "Maximum Peak Power Density" property are similar and do not raise new questions of safety or effectiveness.

The standard of "Maximum Average Current Density" refers to "IEC60601-2-10 Clause 201.4.2" and the standard of "Maximum Peak Power Density" refer to "Guidance Document for Powered Muscle Stimulator 510K Section 3." Indicating similar performance and safety between subject device and predicate device. Otherwise the subject devices are complying with ISO 10993 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue. For detailed measurement data, please refer to the above table. The subject device are Substantially Equivalent to the predicate device.

Note 3: Washable or not.

Subject Device, Primary Predicate K053214 and Secondary Predicate K171721 are made of textiles and can be washed. The subject device are Substantially Equivalent to the predicate device.

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Image /page/13/Picture/1 description: The image shows the logo for Well-life, a company that produces healthcare products. The logo features a yellow butterfly with the company name in blue text. The tagline "Smarter Healthcare Products for Better Living" is written in smaller yellow text below the company name. The butterfly is stylized and has a cut-out design in the lower part of its wings.

10.2. Conclusion:

Although the Note 1: description of Intended Use, Note 2: Design (shape) and size, Note 3: Electrode conductive area and Impedance Parameters, Note 4: Washable or not aren't exactly as same as the Predicate devices, all of their functions and performance are applying in the corresponding device, such as Electrical Stimulator, are substantially equivalent with Predicate device. After Comparison and Evaluation, the subject device Well-Life Garment Electrodes (GM series) has similar features to predicate devices. The few differences are explained and do not impact of the safety and effectiveness. Thus, the subject device is substantially equivalent with Predicate device.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).