The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

Device Description

The Neurological Therapy Devices - Accessories -Conductive fiber(Model:Electrotherapy device Electrode for Knee, Electrotherapy device Electrode for Elbow, Electrotherapy device Electrotherapy device Electrode socks.Neurological physiotherapy devices-accessories), are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into Neurological Therapy Devices - Accessories garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves.

The Neurological Therapy Devices - Accessories-conductive silicone rubber(Model:Electrotherapy device Electrode belt for back of body, Electrotherapy device Electrode belt for Abdominal Muscle TrainerToning, Electrotherapy device Electrode belt for Body joints,Electrotherapy device Electrode belt for arm of body,Electrotherapy device Electrode belt for back of body,Electrotherapy device Electrode belt for shoulder of body,Neurological physiotherapy devices-accessories), is made of conductive silicone rubber coated in conductive garments material, has excellent conductive performance and good flexibility and plasticity, can adapt to the needs of different shapes and sizes of electrodes.

The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin.

The Neurological Therapy Devices - Accessories utilize conductive silicone rubber as a conduit for current transmission. When current passes through the garment electrodes, the conductive silicone rubber transmit the current to the surface of the body, thus enabling the transmission of current. The entire surface of the Neurological Therapy Devices - Accessories is very conductive having a resistance of less than 7 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these Neurological Therapy Devices - Accessories for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices).

The Neurological Therapy Devices - Accessories are non- sterile external devices which are designed for single patient, for multiple uses and are intended for Prescription Use and/or OTC use with FDA Cleared TENS and NMES class II devices.

AI/ML Overview

The provided FDA 510(k) summary (K232995) describes the acceptance criteria and the study conducted to demonstrate that the Neurological Therapy Devices - Accessories meet these criteria.

Here's a breakdown of the requested information:

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material (Biocompatibility)	Compliant with ISO 10993-5:2009 (Cytotoxicity)	Compliant
	Compliant with ISO 10993-23:2021 (Skin Sensitization)	Compliant
	Compliant with ISO 10993-10:2021 (Skin Irritation)	Compliant
Electrical Performance	Resistivity less than 7 ohms per inch	Less than 7 ohms per inch (through multiple washings)
	Uniform delivery of low doses of current to the skin	Achieved during bench testing
Durability/Reusable	Maintain inherent conductivity with multiple washings	Bench testing confirmed no significant adverse effect on conductivity after multiple washings
Intended Use	To be used with legally marketed electrical stimulating devices (TENS/NMES) to deliver stimulation signals	The device is designed and demonstrated to work with such devices.

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

Sample Size for Test Set: The document explicitly states "No clinical testing was performed" (Section 8). Therefore, there isn't a "test set" in the context of human subjects or clinical data. The performance was evaluated through non-clinical bench testing. The sample sizes for the materials tested in biocompatibility and electrical performance bench tests are not specified in this summary.
Data Provenance: The company is Shenzhen Roundwhale Technology Co., Ltd. in China. The testing would presumably have been conducted in China or by laboratories contracted by the company, adhering to international standards. The data is non-clinical (bench testing).

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment in a clinical context. The performance was assessed against technical specifications and international standards in a laboratory setting.

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

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an accessory (an electrode) for electrotherapy devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is not an algorithm-only device. It is a physical accessory (electrode). The "standalone" performance refers to the device's electrical conductivity and biocompatibility, which were assessed via bench testing as described.

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

The "ground truth" for this device's performance is based on:

International Standards: Specifically, ISO 10993 series for biocompatibility testing (ISO 10993-5, ISO 10993-10, ISO 10993-23).
Technical Specifications: Defined electrical performance criteria (e.g., resistivity less than 7 ohms per inch).
Comparison to Predicate Devices: Demonstrating similarity in design, materials, function, and performance to legally marketed devices.

8. The sample size for the training set

Not applicable. As this device is a physical cutaneous electrode and not an AI/machine learning model, there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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January 11, 2024

Shenzhen Roundwhale Technology Co., Ltd. Zou Amos RA Manager 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district Shenzhen, Guangdong 518108 China

Re: K232995

Trade/Device Name: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrotherapy device Electrode for gloves, AC4001, AC4002, AC4003; Electrotherapy device Electrode socks, AC5001, AC5002, AC5003; Electrotherapy device Electrode belt for arm of body, AC7001, AC7002, AC7003; Electrotherapy device Electode belt for back of body, AC8001; Electrode device Electrode belt for shoulder of body, AC9001

Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 12, 2023 Received: December 12, 2023

Dear Zou Amos:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pm.cfm identifies combination

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows the text "Tushar Bansal -S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. The background is a light blue color, with a faint watermark-like design behind the text.

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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

K232995
Device Name
Neurological Therapy Devices - Accessories:
AC1001 Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
AC1002 Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
AC1003 Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
AC1004 Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
AC1005 Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
AC2001 Electrotherapy device Electrode belt for back of body,
AC2002 Electrotherapy device Electrode belt for back of body,
AC2003 Electrotherapy device Electrode belt for back of body,
AC2004 Electrotherapy device Electrode belt for back of body,
AC3002 Electrotherapy device Electrode for Knee,
AC3004 Electrotherapy device Electrode for Knee,
AC3006 Electrotherapy device Electrode for Knee,
AC3003 Electrotherapy device Electrode for Elbow,
AC3005 Electrotherapy device Electrode for Elbow,
AC3007 Electrotherapy device Electrode for Elbow,
AC3001 Electrotherapy device Electrode belt for Body joints,
AC3008 Electrotherapy device Electrode belt for Body joints,
AC3009 Electrotherapy device Electrode belt for Body joints,
AC3010 Electrotherapy device Electrode belt for Body joints,
AC3011 Electrotherapy device Electrode belt for Body joints,
AC4001 Electrotherapy device Electrode gloves,
AC4002 Electrotherapy device Electrode gloves,
AC4003 Electrotherapy device Electrode gloves, AC5001 Electrotherapy device Electrode socks,
AC5002 Electrotherapy device Electrode socks,
AC5003 Electrotherapy device Electrode socks,
AC7001 Electrotherapy device Electrode belt for arm of body,
AC7002 Electrotherapy device Electrode belt for arm of body,
AC7003 Electrotherapy device Electrode belt for arm of body,
AC8001 Electrotherapy device Electrode belt for back of body,
AC9001 Electrotherapy device Electrode belt for shoulder of body,

Indications for Use (Describe)

Submission Number (if known)

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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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510(K) SUMMARY - K232995

1. Submitter of 510(K):

Sponsor

Company Name:	Shenzhen Roundwhale Technology Co., Ltd.
Address:	202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district, Shenzhen, China.
Contact person:	Zeng Chunming
TEL:	+86-755-23212776
FAX:	+86-755-23212776
E-mail:	zcm@roovjoy.com
Date of Prepared:	September 20,2023

Application Correspondent:

Company Name:	Shenzhen Roundwhale Technology Co., Ltd.
Address:	202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district, Shenzhen, China.
Contact person:	Amos Zou
TEL:	+86-15015249549
E-mail:	amos.zou@139.com
Date of Prepared:	September 20,2023

Proposed Device and code: 2.

Device name:	Neurological Therapy Devices - Accessories
Model:	AC3002Electrotherapy device Electrode for Knee,
	AC3004Electrotherapy device Electrode for Knee,
	AC3006Electrotherapy device Electrode for Knee,
	AC3003 Electrotherapy device Electrode for Elbow,
	AC3005Electrotherapy device Electrode for Elbow,
	AC3007Electrotherapy device Electrode for Elbow,
	AC4001 Electrotherapy device Electrode gloves,
	AC4002 Electrotherapy device Electrode gloves,
	AC4003Electrotherapy device Electrode gloves,
	AC5001Electrotherapy device Electrode socks,
	AC5002Electrotherapy device Electrode socks,
	AC5003Electrotherapy device Electrode socks
	AC1001Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
	AC1002Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
	AC1003Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
	AC1004Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
	AC1005Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning,
	AC2001 Electrotherapy device Electrode belt for back of body,
	AC2002Electrotherapy device Electrode belt for back of body,
	AC2003Electrotherapy device Electrode belt for back of body,
	AC2004Electrotherapy device Electrode belt for back of body,
	AC3001Electrotherapy device Electrode belt for Body joints,
	AC3008Electrotherapy device Electrode belt for Body joints,
	AC3009Electrotherapy device Electrode belt for Body joints,
	AC3010Electrotherapy device Electrode belt for Body joints,
	AC3011Electrotherapy device Electrode belt for Body joints,
	AC7001Electrotherapy device Electrode belt for arm of body,
	AC7002Electrotherapy device Electrode beltfor arm of body,
	AC7003Electrotherapy device Electrode beltfor arm of body,
	AC8001 Electrotherapy device Electrode belt for back of body,
	AC9001Electrotherapy device Electrode belt for shoulder of body,
Regulation MedicalSpecialty	Neurology
Product Code	GXY
Regulation Number	882.1320
Device class:	II
Sterilization facility	Not applicable
Type:	Traditional

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3. Predicate Device:

510(K)	Trade or Proprietary or Model Name	Manufacturer
K203158	BioWave BioWraps	BioWave Corporation
K171798	Silverwear Silver Pro Garment Device	Media Plus, LLC
K171721	Electrodes with Silver Conductive	Shenzhen KonmedTechnology, Co. LTD.

4. Description of Proposed Device:

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ਹੈ.

Indications for Use

The Neurological Therapy Devices - Accessories including Garment electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

6. Technical and Performance

The following table compares the device to the predicate device with basic technological characteristics.

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Element ofComparison	Subject Device	Primary Predicate	Reference Predicate	Reference Predicate	Differences
510(K)	K232995	(K203158)	K171798	K171721	Same
Company	Shenzhen Roundwhale TechnologyCo., Ltd.	BioWave Corporation	SilverWear USA,LLC.	Shenzhen KonmedTechnology, Co. LTD.	--
Device Name	Neurological Therapy Devices -Accessories	BioWave BioWraps	SilverPro	Electrodes with SilverConductive	--
RegulationNumber	882.1320	882.1320	882.1320	882.1320	Same
Product Code	GXY	GXY	GXY	GXY	Same
OTC / Rx	OTC and Rx	OTC and Rx	OTC	OTC	Same asK203158
Intended Use /Indications forUse	The Neurological Therapy Devices- Accessories including Garmentelectrodes and Adhesive electrodes,which are intended to be used withlegally marketed electricalstimulating devices such astranscutaneous electrical nervestimulators or powered musclestimulators. The cutaneouselectrodes will deliver thestimulation signals generated by thestimulator to the body surface withwhich they are in contact. TheGarment electrodes including glove,socks, sleeve, knee belt and backbelt which are made up of silver orconductive silicone rubber.	The BioWave BioWraps arecutaneous electrodes to be usedwith legally marketed BioWavebranded neurostimulators. Theknitted garment electrodes arenon-sterile reusable prescription-use and OTC conductive garmentsthat are intended to deliver thestimulation signals generated bythe stimulator to the body surfacewith which they are in contact.These body parts includehands/wrist, elbow, foot/ankle,knee, and lower back.	The Silverwear SilverProSeries ConductiveGarments are cutaneouselectrodes to be used withlegally marketed TENS orNMES devices. Theknitted garment electrodesare non-sterile reusableOTC conductive garmentsthat are intended to deliverthe stimulation signalsgenerated by the stimulatorto the body surface withwhich they are in contact.These body parts caninclude hand (glove), wrist(sleeve), elbow or arm(sleeve), knee or leg(sleeve), knee high	Electrodes with silverconductive as Glove style.Socks style, Wristbands Style,Wrist sleeve, Elbow PadsStyle and Knee Pads Style,Elbow Sleeve, are intendedfor use with legally marketedTENS stimulating device.The electrodes with silverconductive will deliverstimulation signals generatedby the stimulator to the bodysurface with which they are incontact. These body parts caninclude such as hands(gloves), feet (socks), wrist,elbow and knee.	Same
Element ofComparison	Subject Device	Primary Predicate(K203158)	Reference Predicate(K171798)	Reference Predicate(K171721)	Differences
			stockings, ankle(sleeve),back band, and shoulderband.
			Electrode A: Glove Style
Design (Shape)	Wrappable bands for the hand/wrist,elbow, foot/ankle, knee, and lowerback	Wrappable bands for thehand/wrist, elbow, foot/ankle,knee, and lower back	Electrode B: Wrist SleeveElectrode C: Elbow/ArmSleeveElectrode D: Knee/LegSleeveElectrode E: Knee HighSocksElectrode F: Ankle SleeveElectrode G: Back BandElectrode H: ShoulderBand	KM-406: Glove Style KM-407: Socks Style KM-408:Wristbands Style KM-409:Elbow pads StyleKM-410: knee Pads Style	Same asK203158


Size	180*120±5mm	All BioWraps are available insmall/medium (S/M) andlarge/extra- large (L/XL) sizes:	Information not publiclyavailable	Gloves KM-406: 200 cm2
	210*130±5mm			Socks KM-407: 285 cm2Wristbands KM-408: 95 cm2	Similar
	230*85±5mm	Low Back:- S/M: 28-38" Waist- L/XL: 38-50" Waist		Elbow pads KM-409: 160cm2	Impedanceparameters lessthan 7 ohmsresistance/inch
	300*100±5mm			Knee Pads KM-410: 236 cm2
	1100*150±10mm	Knee:- S/M: 12-15.5" Waist
	1300*180±10mm
Element ofComparison	Subject Device	Primary Predicate(K203158)	Reference Predicate(K171798)	Reference Predicate(K171721)	Differences
	550*220±10mm	circumference around the kneecap
	1000*125±10mm	- L/XL: 15.5 - 19"
	520*200±10mm	circumference around the kneecap
	220*180±10mm	Foot/Ankle:
	850*650±10mm	S/M:Women's shoe 6-9,men'sshoe size 7-8.5
	550*350±10mm	L/XL:Women's shoe size 9.5-11,men's shoe size 9-13
	550*220±10mm	Elbow:-S/M:8-12"
		Circumference around the elbowjoint with arm extended
		-L/XL:12-16"
		Circumference around the elbowjoint with arm extended
		Hand/wrist:-S/M:6-9" circumference aroundthe dominant hand
		-L/XL:9-12"
		Circumference around thedominant hand
ImpedanceParameters	7 ohms resistance/inch	1.27 ohms resistance per inch	7 ohms resistance/inch	2 ohms resistance/inch	Same asK171798
Element ofComparison	Subject Device	Primary Predicate(K203158)	Reference Predicate(K171798)	Reference Predicate(K171721)	Differences
Washable / NotWashable	Washable	Washable	Washable	Washable	Same
Reusable	Single Patient, Reusable	Single Patient, Reusable	Single Patient, Reusable	Single Patient, Reusable	Same
Biocompatibility	Compliant with ISO 10993-5/ -10/-23	Compliant with ISO 10993-5 and-10	Compliant with ISO10993-5 and -10	Compliant with ISO 10993-5and -10	same
PatientContactingMaterials	silver fiber,silicone rubber	Silver Fiber	Silver-coated Nylon	Silver-coated Nylon	Similar,Pass thebiocompatibilitytest

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Analysis for the differences:

The subject devices are a garnent cutaneous medical devices that have the same or similar design features, indication, indication, intended use, conductivity, electival connection as the legally marketed predicate devices. The subject devices have similar technological characterialics as the predicate devices. Both the subject and the receive electrostimulation signals from legally marketed TENS devices through a standard electival comection of an electrode which is wired to the subject and the predicate devices are washable and intended for multiple use by a single patient with intact skin.

The subject electrodes are made from conductive silicone rubber and is highly conductive and provides less than 7 ohms resistance per inch which is similar or less than the proces which are fabricated into multiple different gament forms and is cometed to a TENS device which is the source of the current that is delivered by the target skin tissue. The subject devices are non- sterile multinle use devices which are washable using conventional detergents. Benchent the gament electrodes do not change their inherent conductivity with multiple washings so that there is no significant adverse effect on the device or its inherent ability to deliver treatment uniformly to the skin of the wearer even after multiple washings. The biocompatibility testing demonstrates the material is acceptable in comparison to the intended use.

The subject devices, Neurological Therapy Devices - Accessorially equivalent to the predicate and reference devices cited in the table above with respect to indications, design, materials, function, availability (i.e., over-the-counter use), and/or performance.

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Conclusion:

The Neurological Therapy Devices - Accessories have been found to the previously cleared predicate device, BioWave BioWraps(K203158),and the included reference predicates, SilverPro Garment Electrodes with Silver Conductive (K17172) , with respect to indications, design, materials, function, availability, and performance.

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7. Non-Clinical Data:

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:

7.1 Biocompatibility testing

The biocompatibility evaluation for the Neurological Therapy Devices - Accessories conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Neurological Therapy Devices - Accessories will have direct contact with human body only at intact skin, And the testing included the following tests:

Cytotoxicity -ISO 10993-5:2009
Skin Sensitization -ISO 10993-23:2021
Skin Irritation -ISO 10993-10:2021

7.2 Performance testing

Bench testing has been conducted on the fabricate the various forms of the Neurological Therapy Devices - Accessories to demonstrate that the fabric and the devices meet design controls in terms of conductivity and resistivity, and uniform delivery of low doses of current all consistent with that of the predicate devices. Resistivity testing was conducted using standard industry testing to confirm that the resistivity met the standards of less than 7 ohms per inch through multiple washings to confirm the multiple use aspects of the device.

8. Clinical data:

No clinical testing was performed.

9. Conclusions:

The subject device has the Same intended use and Similar characteristics as the predicate device, Meanwhile, performance testing, bench testing, and Biocompatibility testing report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Roundwhale Ltd. maintains that the Neurological Therapy Devices - Accessories is substantially equivalent to the predicate devices in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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).