Who is the manufacturer of DR-HO'S Electro Therapy Conductive Gel?

Guangzhou Xinbo Electronic Co., Ltd. filed the 510(k) submission for DR-HO'S Electro Therapy Conductive Gel (K200402).

What is the FDA product code for DR-HO'S Electro Therapy Conductive Gel?

GYB. It is classified under 21 CFR 882.1275 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for DR-HO'S Electro Therapy Conductive Gel?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DR-HO'S Electro Therapy Conductive Gel?

Conductive Gel (K022006); EndyGel (K161715); Tech Dots (K190050); Electro-Gel (K111717).

Who can help prepare an FDA 510(k) submission like DR-HO'S Electro Therapy Conductive Gel?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DR-HO'S Electro Therapy Conductive Gel

K200402 · Guangzhou Xinbo Electronic Co., Ltd. · GYB · Nov 25, 2020 · Neurology

Device Facts

Record ID	K200402
Device Name	DR-HO'S Electro Therapy Conductive Gel
Applicant	Guangzhou Xinbo Electronic Co., Ltd.
Product Code	GYB · Neurology
Decision Date	Nov 25, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1275
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Conductive gel applied to intact skin; used as interface between external electrodes and skin for TENS/EMS therapy. Reduces electrical impedance; ensures even current distribution. Non-sterile; applied by user or clinician. Benefits patient by improving comfort and effectiveness of electrical stimulation therapy. Composed of purified water, Carbopol, glycerin, sodium hydroxide, and triclosan.

Clinical Evidence

Bench testing only. Evaluated per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation); all tests passed. Usability testing performed per IEC 60601-1-6 and IEC 62366-1. Shelf life validated per ASTM F1980-16 for 2-year duration, confirming performance metrics (pH, conductivity, impedance) remain within specifications.

Technological Characteristics

Electroconductive gel; non-sterile. Composition: 98.25% purified water, 0.5% Carbopol, 1% glycerin, 0.2% sodium hydroxide, 0.05% triclosan. Conductivity: 2 mS/cm; pH: 7.0-7.5. Biocompatible per ISO 10993. Shelf life: 2 years.

Indications for Use

Indicated for use with TENS and EMS therapy to reduce impedance between electrode surface and intact skin.

Regulatory Classification

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.

Predicate Devices

Conductive Gel (K022006)
EndyGel (K161715)
Tech Dots (K190050)
Electro-Gel (K111717)

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: 5~40°C Humidity: ≤80%RH Atmospheric Pressure: 86~106kPa | Not publicly available | Not publicly available | Not publicly available | Not publicly available | -- | | Storage Environment | Temperature: 5~40°C Humidity: ≤95% RH Atmospheric Pressure: 50~106 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 <8 (neutral to Alkaline), which can prove the pH of subject device is safe. So the slight differences in description will not raise any safety or effectiveness issue. ### Finial Conclusion: The subject device "DR-HO'S Electro Therapy Conductive Gel, (Model: DHGEL)" is Substantial Equivalent to the predicate devices K022006, K161715, K190050 and K11171.

DR-HO'S Electro Therapy Conductive Gel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Submission Summary (Full Text)

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DR-HO'S Electro Therapy Conductive Gel

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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