Well-Life Garment Electrodes (GM Series)

K200942 · Well-Life Healthcare Limited · GXY · Jun 1, 2021 · Neurology

Device Facts

• Record ID: K200942
• Device Name: Well-Life Garment Electrodes (GM Series)
• Applicant: Well-Life Healthcare Limited
• Product Code: GXY · Neurology
• Decision Date: Jun 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Well-Life Garment Electrodes (GM Series) are wearable textile electrodes designed for use with legally marketed TENS stimulators; intended as alternatives to traditional cutaneous adhesive patches. Device consists of non-conductive textiles (polyurethane, nylon, polyester) and conductive silver fabric. Models include arm (GM-AM) and elbow (GM-EB) configurations in various sizes. Operation requires wetting the garment before contact with skin; user connects lead wires from a TENS stimulator to snap buttons on the garment. Conductive areas transmit electrical signals from the stimulator to the skin surface. Used in home or clinical settings by patients or clinicians. Benefits include providing a reusable, wearable interface for electrical stimulation therapy on specific anatomical regions. Device is washable and intended for single-patient use.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1, -5, -10, -12), electrical safety/performance (IEC 60601-2-10), impedance distribution uniformity, shelf life (ASTM F1980), and reusability/washability testing.

Technological Characteristics

Materials: Polyurethane, nylon, polyester, and silver-coated conductive fabric. Connectivity: Wired connection via snap buttons to external TENS stimulator. Form factor: Wearable garment (arm/elbow sleeves). Impedance: <14 ohms/inch. Standards: ISO 10993 (biocompatibility), IEC 60601-2-10 (safety/performance), ASTM F1980 (shelf life).

Indications for Use

Indicated for use with legally marketed TENS devices to deliver electrical stimulation signals to the body surface of the arm and elbow.

Regulatory Classification

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.

Predicate Devices

• Theraknit Garment (K053214)
• Electrodes with Silver Conductive (K171721)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 District<br>New Taipei City, 23512, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Jenny Hsieh<br>([e-mail]) |
| Registration number: | 3006850006 |

- 4. 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:

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

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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.

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.

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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.

| Recognition<br>Number | Standard Designation<br>Number And Date | Title Of Standard | Date Of<br>Recognition |
|-----------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 2-258 | ISO 10993-1 Fifth Edition<br>2018-08 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process | 01/14/201<br>9 |
| 2-245 | ISO 10993-5 Third Edition<br>2009-06-01 | Biological evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity | 02/23/201<br>6 |
| 2-174 | ISO 10993-10 Third Edition<br>2010-08-01 | Biological evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | 07/26/201<br>6 |
| 2-191 | ISO 10993-12 Fourth Edition<br>2012-07-01 | Biological evaluation of medical devices - Part 12:<br>Sample preparation and reference materials | 07/26/201<br>6 |
| 17-16 | IEC 60601-2-10 Edition 2.1<br>2016-04 | Medical electrical equipment - Part 2-10:<br>Particular requirements for the basic safety and<br>essential performance of nerve and muscle<br>stimulators | 06/27/201<br>6 |
| 5-125 | ISO 14971 Third Edition 2019-<br>12 | Medical devices - Application of risk management<br>to medical devices | 12/23/201<br>9 |

### 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)
- 2) 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<br>(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/<br>Indication for use | The Well Life Garment Electrodes | The TheraKnit Garment electrodes | Electrodes with silver conductive | Similar |
| | (GM Series) are intended to be<br>used with legally marketed TENS<br>devices. | are cutaneous to be used with<br>legally tens Stimulating device. | as glove style, socks style,<br>wristbands style, wrist sleeve,<br>elbow pads style and knee pads<br>style, elbow sleeve, are intended<br>for use with legally marketed<br>TENS stimulating device. The<br>electrodes with silver conductive<br>will deliver stimulation signals<br>generated by the stimulator to the<br>body surface with which they are<br>in contact.<br>These body parts can include such<br>as hands (gloves), feet (socks)<br>wrist, elbow and knee. | (Note.1) |
| | The Well-Life Garment Electrodes<br>(GM Series) will deliver the<br>stimulation signals generated by<br>the stimulator to the body surface<br>with which they are in contact. | The knitted garment electrodes will<br>deliver the stimulation signals<br>generated by the stimulator to the<br>body surface with which they are<br>in contact. These body parts can<br>included hand(glove), feet (socks),<br>elbow or knee (sleeve),arm, leg,<br>shoulder, back(pads) | | |
| | They can be used on body parts<br>such as arm and elbow. | | | |
| Design (Shape)/ Model | GM-AM-R-X00 / GM-AM-O-X00<br>Arm RX/OTC<br>GM-EB-R-X00 / GM-EB-O-X00<br>Elbow RX/OTC | Electrode A: Glove Style<br>Electrode B: Socks Style<br>Electrode C: Sleeve Style<br>Electrode D: Pads Style | KM-406: Glove Style<br>KM-407: Socks Style<br>KM-408: Wristbands Style<br>KM-409: Elbow pads Style<br>KM-410:Knee Pads Style | Similar<br>(Note.2) |
| Size | Arm (S/M/L)<br>Elbow (S/M/L) | All sizes | One size below is size for when<br>without stretched:<br>KM-406: 200(cm²)<br>KM-407: 285(cm²)<br>KM-408: 95 (cm²)<br>KM-409: 160(cm²)<br>KM-410: 236(cm²) | Similar<br>(Note.2) |
| Anatomical locations of use | | | | Similar |
| | Arm<br>Elbow | Hands<br>Feet<br>Elbow<br>Knee<br>Arm<br>Leg<br>Shoulder<br>Back | Hands<br>Feet<br>Wrist<br>Elbow<br>Knee | (Note.2) |
| Impedance Parameters | 14 ohms resistance per inch | 7 ohms resistance per inch | 2 ohms resistance per inch | Similar<br>(Note.2) |
| Biocompatibility | Complying with ISO 10993<br>requirements | Complying with ISO 10993<br>requirements | Complying with ISO 10993<br>requirements | Same<br>(Note.2) |
| Power Source | legally Marketed Electrical<br>Stimulator | legally Marketed Electrical<br>Stimulator | legally Marketed Electrical<br>Stimulator | Same |
| Maximum Average Current Density<br>(@500 Ω) | 0.254 mA/cm² (arm)<br>0.392 mA/cm² (elbow) | not publicly available | not publicly available | |
| Maximum Peak Power Density<br>(@500 Ω) | 1.255 mW/cm² (arm)<br>1.958 mW/cm² (elbow) | not publicly available | not publicly available | |
| Washable or not | Washable | Washable | Washable | Similar<br>(Note.3) |
| Re-usable | For single Patient | For single Patient | For single Patient | Same |
| Conductive surface area | Arm:<br>Area 1: 39.00 cm²<br>Area 2: 39.00 cm²<br>Elbow:<br>Area 1: 25.50 cm² | Not publicly available | One size<br>Below is size for when without<br>stretched:<br>KM-406: 400 (cm²)<br>KM-407: 570 (cm²)<br>KM-408: 190 (cm²)<br>KM-409: 320 (cm²)<br>KM-410: 472 (cm²) | |
| Patient contacting material | Non-conductive textiles<br>(polyurethane, nylon and polyester)<br>and conductive textiles (Silver<br>Fabric) | 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.