(280 days)
No
The device is a conductive gel, a chemical formulation, and the description focuses on its physical properties and chemical composition, with no mention of software, algorithms, or data processing.
No
The device is a conductive gel intended for use with TENS and EMS therapy devices, not a therapeutic device itself. It functions as an accessory to reduce impedance for therapeutic devices.
No.
The device is a conductive gel used to reduce impedance between electrodes and skin for TENS/EMS therapy, not to diagnose a condition.
No
The device is a gel, which is a physical substance, not software.
Based on the provided information, DR-HO'S Electro Therapy Conductive Gel is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce impedance between electrodes and the skin for TENS and EMS therapy. This is a topical application for a physical therapy device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the chemical composition and how it's applied to intact skin. It doesn't involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen for diagnostic purposes. The performance studies are related to skin compatibility and usability, not diagnostic accuracy.
Therefore, this device falls under the category of a medical device used in conjunction with other medical devices (TENS/EMS units), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Product codes (comma separated list FDA assigned to the subject device)
GYB
Device Description
DR-HO'S Electro Therapy Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%, And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative.
The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surfaces
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)
The subject device "DR-HO'S Electro Therapy Conductive Gel (Model: DHGEL)" has been evaluated for safety and performance by lab bench testing.
- In vitro Cytotoxicity Test: Determined to be non-cytotoxic. Reference Standard: ISO 10993-5:2009.
- Skin Sensitization Test: Determined to be non-sensitizing. Reference Standard: ISO 10993-10:2010.
- Skin Irritation Test: Determined to be non-irritating. Reference Standard: ISO 10993-10:2010.
- Usability Study: Meets usability goals of IEC 60601-1-6 and IEC 62366-1 standards. Reference Standard: IEC 60601-1-6 Edition 3.1 2013-10, IEC 62366-1 Edition 1.0 2015-02.
- Shelf Life Test: Performance met 2-year shelf life requirements for visual inspection, pH, conductivity, impedance, and microbiological indicators. Reference Standard: ASTM F1980-16.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics mentioned are pH (7.0 - 7.5), Conductivity (2 mS/cm), and Impedance (500Ω).
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
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name is in blue text.
November 25, 2020
Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, 510700 China
Re: K200402
Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Regulation Number: 21 CFR 882.175 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: August 13, 2020 Received: August 28, 2020
Dear Cassie Lee:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200402
Device Name
DR-HO'S Electro Therapy Conductive Gel (Model: DHGEL)
Indications for Use (Describe)
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
| 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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3
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Guangzhou Xinbo Electronic Co., Ltd. Address: 23 Building, Phase-II, Huachuang Industry Park, Panyu, Guangzhou, China. Contact name: Sammy Li Title: Manager Tel: +86-020-66393598 Fax: +86-020-34822409 E-mail: drtvsammy@hotmail.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: November 25, 2020
3. Subject Device Information
Company Name: Guangzhou Xinbo Electronic Co., Ltd. Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Model Name: DHGEL Classification Name: Media, Electroconductive Common Name: Electroconductive Media Product Code: GYB Regulation Number: 882.1275 Regulatory Class: 2
4. Predicate Device Information
4
| Sponsor | THE DEZAC GROUP | EndyMed Medical Ltd. | Spes Medica S.r.l. |
|---|---|---|---|
| Device Name | Conductive Gel | EndyGelTM | Tech Dots |
| 510(k) Number | K022006 | K161715 | K190050 |
| Product Code | GYB | GYB | GYB |
| Regulation Number | 882.1275 | 882.1275 | 882.1275 |
| Regulation Class | II | II | II |
5. Device Description
DR-HO'S Electro Therapy Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%, And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative.
The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
Intended Use / Indications for Use 6.
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external to reduce the impedance of the contact between the electrode surface and the skin.
7. Test Summary
DR-HO'S Electro Therapy Conductive Gel (Model: DHGEL) has been evaluated the safety and performance by lab bench testing as following:
| Test Item | Purpose of the
test | Reference
Standard | Acceptance
criteria | Test results |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| In vitro Cytotoxicity
Test | Under the
research
conditions,
determine whether
the target device
extract is cytotoxic. | ISO 10993-5:2009
Biological
evaluation of
medical devices-
Part 5: Tests for in
vitro cytotoxicity | Under the
conditions of the
study, the subject
device extract was
determined to be
non-cytotoxic. | Pass |
| Skin Sensitization
Test | Under the
research
conditions,
determine whether
the non-polar and
polar extracts of
the target device
are sensitive. | ISO 10993-
10:2010 Biological
evaluation of
medical devices-
Part 10: Tests for
irritation and skin
sensitization | Under the
conditions of the
study, the subject
device non-polar
and polar extracts
were determined
to be non-
sensitizing. | Pass |
| Skin Irritation Test | Under the
research
conditions,
determine whether
the non-polar and
polar extracts of
the target device
are irritating. | ISO 10993-
10:2010 Biological
evaluation of
medical devices-
Part 10: Tests for
irritation and skin
sensitization | Under the
conditions of the
study, the subject
device non-polar
and polar extracts
were determined
to be non-irritating. | Pass |
| Usability Study | To study how
usability will be
performed in
subject device in
order to comply
with IEC 62366-1
and IEC 60601-1-6 | IEC 60601-1-6
Edition 3.1 2013-
10, Medical
electrical
equipment - Part
1-6: General
requirements for
basic safety and
essential
performance -
Collateral
standard: Usability
IEC 62366-1
Edition 1.0 2015-
02, Medical
devices - Part 1:
Application of
usability
engineering to
medical devices
[Including
CORRIGENDUM 1
(2016)] | The subject device
can meet the
usability goal of
IEC 60601-1-6 and
IEC 62366-1
standards. | Pass |
| Shelf Life Test | To study whether
the performance of
subject device can
meet the 2-year
shelf life
requirements | ASTM F1980-16:
Standard Guide for
Accelerated Aging
of Sterile Barrier
Systems for
Medical Devices;
Guidance
document for the
"Shelf Life of
Medical Devices"
issued in April
1991 | All items (Visual
Inspection,
pH, conductivity,
Impedance and
Microbiological
indicators) tested
on both before and
after aging
samples
meet performance
required. | Pass |
5
6
Comparison to predicate device and conclusion 8.
The technological characteristics, features, specifications, materials, and intended use of Electrode is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
7
| Elements of
Comparison | Subject Device | Predicate
Device 1
(Primary
predicate) | Predicate Device 2 | Predicate Device
3 | Predicate Device 4 | Remarks | Body contact | Intact Skin | Not publicly
available | Intact Skin | Intact Skin | Intact Skin | SE |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------|-----------------------------------------|---------------------------|-----------------------------------------------|--------------------------|----------------------------------|--------------|
| Device Name
and Model | DR-HO'S Electro
Therapy
Conductive Gel
Model: DHGEL | Conductive Gel | EndyGel™ | Tech Dots -
Conductive gel | Electro-Gel | -- | sterilization | non-sterile | Not publicly
available | non-sterile | non-sterile | non-sterile | SE |
| 510(k) Number | Applying | K022006 | K161715 | K190050 | K111717 | -- | Shelf life | 2 years | Not publicly
available | 2 years | 3 years | 1 year | SE |
| Product Code | GYB | GYB | GYB | GYB | GYB | SE | Weight | 250g / bottle | Not publicly
available | Not publicly available | 0.14 ± 0.01 g per
Dot | 16 ounce, 32
ounce, 128 ounce | -- |
| Intended Use /
Indications for
Use | DR-HO'S Electro
Therapy
Conductive Gel is
intended for use
with TENS
(transcutaneous
electrical nerve
stimulation) and
EMS (electronic
muscle
stimulation)
therapy. It is to be
use to moisten the
electrodes and the
skin, to reduce
impedance of the
contact between
the electrode
surface and the
skin. This helps to
provide a more
comfortable and
effective
treatment. | The Conductive
Gel is intended
for use with
TENS
(transcutaneous
electrical nerve
stimulators) and
EMS(electrical
muscle
stimulators). The
Conductive Gel is
used with
external to
reduce the
impedance of the
contact between
the electrode
surface and the
skin. | EndyGel™ is an Electroconductive gel
media used with external electrode to
reduce the impedance (resistance to
alternating current) of the contact
between the electrode surface and the
skin. | Tech Dots are
intended for use in
clinical and
research EEG/EP
recordings from
humans. They are
used with external
electrodes as the
conductor
between the scalp
and recessed
electrodes to
reduce impedance
between the
electrode surface
and the skin. | This device is
intended for use in
clinical and
research EEG/EP
recordings from
humans. The
Electro-Gel is used
with external
electrodes as the
conductor between
the scalp and the
(recessed)
electrodes. It also
reduces impedance
(resistance to
alternating current)
between the
electrode surface
and the skin. | SE
Note 1 | Impedance | $500Ω$ | Not publicly
available | $527.68Ω$ | $80 ± 10 Ohm$ | $≤500Ω$ | SE
Note 2 |
| Regulation
Number | 882.1275 | 882.1275 | 882.1275 | 882.1275 | 882.1275 | SE | Conductive
material | Purified water with
Sodium hydroxide | Not publicly
available | Water (Aqua) with immersed
Triethanolamine | Salt (NaCl) | Salt (NaCl) | SE
Note 3 |
| Composition | - Purified water
(solvent);
-
Carbopol (gel
forming);
-
Glycerin
(Moisturizing);
-
Sodium
hydroxide
(Buffering);
-
Triclosan
(preservative) | Not publicly
available | - Water (solvent);
-
Carbomer (gel forming); -
Triethanolamine (Buffering); -
Methylisothiazolinone(preservative) | - Water -
Glycerol
(vegetable
origin)
-
Polyacrylate
co-polymer
(proprietary)
-
Potassium
chloride | - Aragum
-
Glycerine -
Methyparaben -
Propylprarben | SE
Note 4 | | | | | | | |
| Percent
concentration
of each
ingredient | - Purified water:
98.25%
-
Carbopol:
0.5%
-
Glycerin: 1% -
Sodium
hydroxide:
0.2%
-
Triclosan:
0.05% | Not publicly
available | Not publicly available | Not publicly
available | Not publicly
available | -- | | | | | | | |
| Conductivity
(S/m) | 2 mS/cm | Not publicly
available | Not publicly available | 2 mS/cm | Not publicly
available | SE | | | | | | | |
8
9
| pH | 7.0 - 7.5 | Not publicly
available | 7.15 - 7.33 | 4 - 5 | 4.5 - 6.0 | SE
Note 5 |
|--------------------------|------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|--------------|
| Biocompatibility | Complied with
ISO 10993-5, ISO
10993-10 | Not publicly
available | Complied with ISO 10993-5, ISO 10993-
10 | Complied with ISO
10993-5, ISO
10993-10 | Complied with ISO
10993-5, ISO
10993-10 | SE |
| Cytotoxicity | Yes | Not publicly
available | Yes | Yes | Yes | SE |
| Irritation | Yes | Not publicly
available | Yes | Yes | Yes | SE |
| Sensitization | Yes | Not publicly
available | Yes | Yes | Yes | SE |
| Operating
Environment | Temperature:
540°C106kPa | Not publicly
Humidity:
≤80%RH
Atmospheric
Pressure:
86
available | Not publicly available | Not publicly
available | Not publicly
available | -- |
| Storage
Environment | Temperature:
540°C106
Humidity: ≤95%
RH
Atmospheric
Pressure: 50
kPa | Not publicly
available | Not publicly available | Not publicly
available | Not publicly
available | -- |
Comparison in Detail(s):
Note 1:
Although the "Intended use" of subject device is a little different from predicate devices, we can find that their core is to reduce the impedance to the skin without affecting the use of the slight differences in description will not raise any safety or effectiveness issue.
Note 2:
Although the "Impedance" of the subject device is a little different from the predicate of 5002 which is very similar to the impedance 527.68Ω of the predicate device (K161715) and ≤500Ω of the predicate device (K11717). Considering that, no new questions of safety or effectiveness are raised.
10
Note 3:
Although the "Conductive material" of the subject devices, but they all composed of water (solvent) and / or conductive buffer to achieve conductivity of the slight differences in description will not raise any safety or effectiveness issue.
Note 4:
Although the specific materials of subject devices, but both the materials for the materials for the subject device and for the predicate device have substantially equival, gel forming, Moisturizing, Buffering, preservative) in the process of producing the gel, so these differences do not raise different issue of safety or effectiveness.
Note 5:
Although the "ph" of the subject device is a little different from predicate device (K161715), but the difference is slight, and it is close to the pH value of human skin surface, the pH is closed to 7 (neutral), beside, even the water for drinking is required