(111 days)
No
The device description focuses solely on the materials and construction of conductive garments and silicone rubber electrodes for delivering electrical stimulation, with no mention of data processing, algorithms, or learning capabilities.
Yes.
The device description explicitly states its intended use with transcutaneous electrical nerve stimulators (TENS) and powered muscle stimulators (NMES) to deliver stimulation signals to the body, which are therapeutic applications.
No
The device is described as an accessory for electrical stimulating devices (TENS and NMES) to deliver stimulation signals to the body surface. Its purpose is therapy (neurological therapy devices), not diagnosis.
No
The device description clearly details physical components made of conductive materials (nylon, lycra, spandex, polyester, carbon yarn, silver-coated nylon fibers, conductive silicone rubber) fabricated into garments. It also describes performance testing related to the physical properties of these materials (conductivity, resistivity, uniform current delivery). This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an accessory to electrical stimulating devices (TENS and NMES). Its function is to deliver electrical stimulation signals to the body surface.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
- Intended Use: The intended use is for delivering electrical stimulation for therapeutic purposes, not for diagnostic testing of biological samples.
The device is an external accessory for electrotherapy, not a diagnostic tool that analyzes samples from within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface, hand, wrist, elbow, foot, ankle, knee, lower back, leg, shoulder, feet, arm, abdominal muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistivity less than 7 ohms per inch.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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,
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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
3
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.
4
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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5
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 Medical | |
| Specialty | Neurology |
| Product Code | GXY |
| Regulation Number | 882.1320 |
| Device class: | II |
| Sterilization facility | Not applicable |
| Type: | Traditional |
6
7
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 |
| 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.
8
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.
9
| Element of
| Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference Predicate | Differences |
|---|---|---|---|---|---|
| 510(K) | K232995 | (K203158) | K171798 | K171721 | Same |
| Company | Shenzhen Roundwhale Technology | ||||
| Co., Ltd. | BioWave Corporation | SilverWear USA,LLC. | Shenzhen Konmed | ||
| Technology, Co. LTD. | -- | ||||
| Device Name | Neurological Therapy Devices - | ||||
| Accessories | BioWave BioWraps | SilverPro | Electrodes with Silver | ||
| Conductive | -- | ||||
| Regulation | |||||
| 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 |
| K203158 | |||||
| Intended Use / | |||||
| Indications for | |||||
| Use | The Neurological Therapy Devices |
- Accessories including Garment
electrodes and Adhesive 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. | The BioWave BioWraps are
cutaneous electrodes to be used
with legally marketed BioWave
branded neurostimulators. The
knitted garment electrodes are
non-sterile reusable prescription-
use and OTC conductive garments
that are intended to deliver the
stimulation signals generated by
the stimulator to the body surface
with which they are in contact.
These body parts include
hands/wrist, elbow, foot/ankle,
knee, and lower back. | The Silverwear SilverPro
Series Conductive
Garments are cutaneous
electrodes to be used with
legally marketed TENS or
NMES devices. The
knitted garment electrodes
are non-sterile reusable
OTC conductive garments
that are intended to deliver
the stimulation signals
generated by the stimulator
to the body surface with
which they are in contact.
These body parts can
include hand (glove), wrist
(sleeve), elbow or arm
(sleeve), knee or leg
(sleeve), knee high | Electrodes with silver
conductive as Glove style.
Socks style, Wristbands Style,
Wrist sleeve, Elbow Pads
Style and Knee Pads Style,
Elbow Sleeve, are intended
for use with legally marketed
TENS stimulating device.
The electrodes with silver
conductive will deliver
stimulation signals generated
by the stimulator to the body
surface with which they are in
contact. These body parts can
include such as hands
(gloves), feet (socks), wrist,
elbow and knee. | Same |
| Element of
Comparison | Subject Device | Primary Predicate
(K203158) | Reference Predicate
(K171798) | Reference Predicate
(K171721) | Differences |
| | | | stockings, ankle(sleeve),
back band, and shoulder
band. | | |
| | | | Electrode A: Glove Style | | |
| Design (Shape) | Wrappable bands for the hand/wrist,
elbow, foot/ankle, knee, and lower
back | Wrappable bands for the
hand/wrist, elbow, foot/ankle,
knee, and lower back | Electrode B: Wrist Sleeve
Electrode C: Elbow/Arm
Sleeve
Electrode D: Knee/Leg
Sleeve
Electrode E: Knee High
Socks
Electrode F: Ankle Sleeve
Electrode G: Back Band
Electrode H: Shoulder
Band | KM-406: Glove Style KM-
407: Socks Style KM-408:
Wristbands Style KM-409:
Elbow pads Style
KM-410: knee Pads Style | Same as
K203158 |
| | | | | | |
| | | | | | |
| Size | 180120±5mm | All BioWraps are available in
small/medium (S/M) and
large/extra- large (L/XL) sizes: | Information not publicly
available | Gloves KM-406: 200 cm2 | |
| | 210130±5mm | | | Socks KM-407: 285 cm2
Wristbands KM-408: 95 cm2 | Similar |
| | 230*85±5mm | Low Back:
- S/M: 28-38" Waist
- L/XL: 38-50" Waist | | Elbow pads KM-409: 160
cm2 | Impedance
parameters less
than 7 ohms
resistance/inch |
| | 300100±5mm | | | Knee Pads KM-410: 236 cm2 | |
| | 1100150±10mm | Knee: - S/M: 12-15.5" Waist | | | |
| | 1300180±10mm | | | | |
| Element of
Comparison | Subject Device | Primary Predicate
(K203158) | Reference Predicate
(K171798) | Reference Predicate
(K171721) | Differences |
| | 550220±10mm | circumference around the kneecap | | | |
| | 1000125±10mm | - L/XL: 15.5 - 19" | | | |
| | 520200±10mm | circumference around the kneecap | | | |
| | 220180±10mm | Foot/Ankle: | | | |
| | 850650±10mm | S/M:Women's shoe 6-9,men's
shoe size 7-8.5 | | | |
| | 550350±10mm | L/XL:Women's shoe size 9.5-
11,men's shoe size 9-13 | | | |
| | 550220±10mm | Elbow:
-S/M:8-12" | | | |
| | | Circumference around the elbow
joint with arm extended | | | |
| | | -L/XL:12-16" | | | |
| | | Circumference around the elbow
joint with arm extended | | | |
| | | Hand/wrist:
-S/M:6-9" circumference around
the dominant hand | | | |
| | | -L/XL:9-12" | | | |
| | | Circumference around the
dominant hand | | | |
| Impedance
Parameters | 7 ohms resistance/inch | 1.27 ohms resistance per inch | 7 ohms resistance/inch | 2 ohms resistance/inch | Same as
K171798 |
| Element of
Comparison | Subject Device | Primary Predicate
(K203158) | Reference Predicate
(K171798) | Reference Predicate
(K171721) | Differences |
| Washable / Not
Washable | 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 ISO
10993-5 and -10 | Compliant with ISO 10993-5
and -10 | same |
| Patient
Contacting
Materials | silver fiber,
silicone rubber | Silver Fiber | Silver-coated Nylon | Silver-coated Nylon | Similar,
Pass the
biocompatibility
test |
10
11
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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.