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; Electrothe

K232995 · Shenzhen Roundwhale Technology Co. , Ltd. · GXY · Jan 11, 2024 · Neurology

Device Facts

• Record ID: K232995
• 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; Electrothe
• Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jan 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device consists of conductive garments (gloves, socks, sleeves, belts) made of silver-coated nylon or conductive silicone rubber; used as accessories for FDA-cleared TENS or powered muscle stimulators. Garments act as cutaneous electrodes; receive electrical stimulation signals from a stimulator; transmit current to the patient's skin surface. Designed for single-patient, multiple-use; washable. Used in home or clinical settings by patients or clinicians. Provides uniform current distribution for electrotherapy; benefits include non-invasive pain management or muscle stimulation. Healthcare providers or patients connect the garment to a stimulator; output is controlled by the stimulator device; garment serves only as the conductive interface.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10, -23) and performance testing (resistivity/conductivity verification after multiple washings).

Technological Characteristics

Conductive garments made of nylon, lycra, spandex, polyester, and silver-coated nylon or conductive silicone rubber. Sensing/actuation: passive conductive interface for TENS/NMES. Connectivity: wired connection to external stimulator. Sterilization: non-sterile. Biocompatibility: ISO 10993-5, -10, -23 compliant. Resistivity: <7 ohms/inch.

Indications for Use

Indicated for use with legally marketed TENS or powered muscle stimulators to deliver stimulation signals to the body surface of patients requiring electrotherapy.

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

• BioWave BioWraps (K203158)
• Silverwear Silver Pro Garment Device (K171798)
• Electrodes with Silver Conductive (K171721)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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.

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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: | [phone] |
| FAX: | [phone] |
| E-mail: | [e-mail] |
| 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: | [phone] |
| E-mail: | [e-mail] |
| 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 Medical<br>Specialty | 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 Konmed<br>Technology, Co. LTD. |

#### 4. Description of Proposed Device:

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.

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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 of<br>Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference Predicate | Differences |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 510(K) | K232995 | (K203158) | K171798 | K171721 | Same |
| Company | Shenzhen Roundwhale Technology<br>Co., Ltd. | BioWave Corporation | SilverWear USA,LLC. | Shenzhen Konmed<br>Technology, Co. LTD. | -- |
| Device Name | Neurological Therapy Devices -<br>Accessories | BioWave BioWraps | SilverPro | Electrodes with Silver<br>Conductive | -- |
| Regulation<br>Number | 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 as<br>K203158 |
| Intended Use /<br>Indications for<br>Use | The Neurological Therapy Devices<br>- Accessories including Garment<br>electrodes and Adhesive electrodes,<br>which are intended to be used with<br>legally marketed electrical<br>stimulating devices such as<br>transcutaneous electrical nerve<br>stimulators or powered muscle<br>stimulators. The cutaneous<br>electrodes will deliver the<br>stimulation signals generated by the<br>stimulator to the body surface with<br>which they are in contact. The<br>Garment electrodes including glove,<br>socks, sleeve, knee belt and back<br>belt which are made up of silver or<br>conductive silicone rubber. | The BioWave BioWraps are<br>cutaneous electrodes to be used<br>with legally marketed BioWave<br>branded neurostimulators. The<br>knitted garment electrodes are<br>non-sterile reusable prescription-<br>use and OTC conductive garments<br>that are intended to deliver the<br>stimulation signals generated by<br>the stimulator to the body surface<br>with which they are in contact.<br>These body parts include<br>hands/wrist, elbow, foot/ankle,<br>knee, and lower back. | The Silverwear SilverPro<br>Series Conductive<br>Garments are cutaneous<br>electrodes to be used with<br>legally marketed TENS or<br>NMES devices. The<br>knitted garment electrodes<br>are non-sterile reusable<br>OTC conductive garments<br>that are intended to deliver<br>the stimulation signals<br>generated by the stimulator<br>to the body surface with<br>which they are in contact.<br>These body parts can<br>include hand (glove), wrist<br>(sleeve), elbow or arm<br>(sleeve), knee or leg<br>(sleeve), knee high | Electrodes with silver<br>conductive as Glove style.<br>Socks style, Wristbands Style,<br>Wrist sleeve, Elbow Pads<br>Style and Knee Pads Style,<br>Elbow Sleeve, are intended<br>for use with legally marketed<br>TENS stimulating device.<br>The electrodes with silver<br>conductive will deliver<br>stimulation signals generated<br>by the stimulator to the body<br>surface with which they are in<br>contact. These body parts can<br>include such as hands<br>(gloves), feet (socks), wrist,<br>elbow and knee. | Same |
| Element of<br>Comparison | Subject Device | Primary Predicate<br>(K203158) | Reference Predicate<br>(K171798) | Reference Predicate<br>(K171721) | Differences |
| | | | stockings, ankle(sleeve),<br>back band, and shoulder<br>band. | | |
| | | | Electrode A: Glove Style | | |
| Design (Shape) | Wrappable bands for the hand/wrist,<br>elbow, foot/ankle, knee, and lower<br>back | Wrappable bands for the<br>hand/wrist, elbow, foot/ankle,<br>knee, and lower back | Electrode B: Wrist Sleeve<br><br>Electrode C: Elbow/Arm<br>Sleeve<br><br>Electrode D: Knee/Leg<br>Sleeve<br><br>Electrode E: Knee High<br>Socks<br><br>Electrode F: Ankle Sleeve<br><br>Electrode G: Back Band<br><br>Electrode H: Shoulder<br>Band | KM-406: Glove Style KM-<br>407: Socks Style KM-408:<br>Wristbands Style KM-409:<br>Elbow pads Style<br><br>KM-410: knee Pads Style | Same as<br>K203158 |
| | | | | | |
| | | | | | |
| Size | 180*120±5mm | All BioWraps are available in<br>small/medium (S/M) and<br>large/extra- large (L/XL) sizes: | Information not publicly<br>available | Gloves KM-406: 200 cm2 | |
| | 210*130±5mm | | | Socks KM-407: 285 cm2<br>Wristbands KM-408: 95 cm2 | Similar |
| | 230*85±5mm | Low Back:<br>- S/M: 28-38" Waist<br>- L/XL: 38-50" Waist | | Elbow pads KM-409: 160<br>cm2 | Impedance<br>parameters less<br>than 7 ohms<br>resistance/inch |
| | 300*100±5mm | | | Knee Pads KM-410: 236 cm2 | |
| | 1100*150±10mm | Knee:<br>- S/M: 12-15.5" Waist | | | |
| | 1300*180±10mm | | | | |
| Element of<br>Comparison | Subject Device | Primary Predicate<br>(K203158) | Reference Predicate<br>(K171798) | Reference Predicate<br>(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: | |…