(164 days)
No
The device description focuses solely on the physical components and function of an adhesive electrode for electrical stimulation, with no mention of AI or ML.
No.
The DL Adhesive Electrode is an accessory intended to transmit electrical current from a therapeutic device (TENS/EMS) to the patient's skin, but it is not itself a therapeutic device.
No
The device is an adhesive electrode intended to transmit electrical current from transcutaneous electrical stimulation devices (like TENS or EMS) to the patient's skin for therapeutic purposes, rather than to diagnose a condition.
No
The device description clearly outlines physical components (top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, carrier liner) and describes bench testing of these physical components, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices." This describes a device that interacts with the patient's body externally to deliver electrical stimulation, not a device that analyzes samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description details the physical components and how it functions as an accessory to TENS or EMS devices, facilitating the delivery of electrical current to the skin. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly described as an accessory for electrical stimulation devices used on the skin.
N/A
Intended Use / Indications for Use
DL Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
Product codes
GXY
Device Description
DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.
DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene).
DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.
The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
- ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-2-2 Edition 6.0 2017-03, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2019
Shaoxing DL Healthcare Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 Cn
Re: K182111
Trade/Device Name: DL Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 12, 2018 Received: October 22, 2018
Dear Doris Dong:
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 (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/cdrh/cfdocs/cfpmn/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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, VivekJ. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182111
Device Name DL Adhesive Electrode
Indications for Use (Describe)
DL Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over The Counter Use (21 CFR 801 Subpart C) |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K182111 |
|---|---|
| Date: | January 17, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | SHAOXING DL HEALTHCARE CO., LTD |
| JIUJIN LAND, BAIGUAN STREET, SHANGYU DISTRICT, | |
| SHAOXING CITY, ZHEJIANG PROVINCE, CHINA, 312300 | |
| Contactor: | Doris Dong (Consultant) |
| Shanghai CV Technology Co., Ltd. | |
| Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 |
2. Device Description:
| Proprietary Name: | DL Adhesive Electrode |
|---|---|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | DL Adhesive Electrode is intended to transmit electrical current to patient |
| skin for use with transcutaneous electrical stimulation devices. Some | |
| common types of the stimulation devices include, but are not limited to | |
| TENS (Transcutaneous Electrical Nerve Stimulation) and EMS | |
| (Electrical Muscular Stimulation). The electrode is for OTC (Over-The | |
| -Counter) or Prescription use. | |
| Device Description: | DL Adhesive Electrode is used as an accessory to the TENS or EMS |
| device unit, which transmits electrical current to patient skin. The | |
| electrical current of Electrode Pad is first transmitted via the snap button | |
| or lead wire then transmitted to the conductive gel which is adhered to | |
| patient skin. |
DL Adhesive Electrode is composed of a top cover, connector snap button
or lead wire, conductive carbon film, conductive hydrogel media, and a
carrier liner. The carrier liner is made of PET (polyethylene terephthalate)
or LDPE(Low Density Polyethylene).
DL Adhesive Electrode is non-sterile and intended for single adult patient
multiple application use. The Adhesive Electrode has various shapes and
sizes. |
4
To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.
The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
3. Predicate Device Identification
K152648--Ennova Self-adhesive Electrode--January 12, 2016
K 100418--Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode -- September 3, 2010
4. Non-Clinical Test Conclusion
Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
-
ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
-
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-2-2 Edition 6.0 2017-03, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
5. Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not including in this submission.
6. Substantially Equivalent Comparison Conclusion
*Basic technological characteristics, New device VS. Primary Predicate device:
| New Device | Predicate Device | |
|---|---|---|
| 501(k) number | K182111 | K152648 |
| Trade Name: | DL Adhesive Electrode | Ennova Self-adhesive Electrode |
| Common Name: | Cutaneous electrode | Cutaneous electrode |
| Classification | Cutaneous electrode | Cutaneous electrode |
5
DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
| Name: | ||
|---|---|---|
| Product Code: | GXY | GXY |
| Regulation Number: | 882.1320 | 882.1320 |
| Medical Specialty: | Neurology | Neurology |
| Device Class: | II | II |
| Indications for use: | DL Adhesive Electrode is intended to transmit | |
| electrical current to patient skin for use with | ||
| transcutaneous electrical stimulation devices. Some | ||
| common types of the stimulation devices include, | ||
| but are not limited to TENS (Transcutaneous | ||
| Electrical Nerve Stimulation) and EMS (Electrical | ||
| Muscular Stimulation). The electrode is for OTC | ||
| (Over-The-Counter) or Prescription use. | Ennova Self-adhesive Electrode is intended | |
| to transmit electrical current to patient skin | ||
| for use with transcutaneous electrical | ||
| stimulation devices. Some common types of | ||
| the stimulation devices include, but are not | ||
| limited to TENS (Transcutaneous Electrical | ||
| Nerve Stimulation) and EMS (Electrical | ||
| Muscular Stimulation). The electrode is for | ||
| OTC (Over-The -Counter) or Prescription | ||
| use. | ||
| Target population: | Single patient use and multiple application | Single patient use and multiple application |
| Prescription use | OTC and Prescription use | OTC and Prescription use |
| Design (shape & | ||
| connection): | Electrode Pad: Round, rectangle, butterfly, oval, | |
| according to customized specification. |
Lead wire with female socket, or snap button with
male snap connector | Round, rectangle, oval, butterfly according to
customized specification.
Lead wire with female socket, or snap button
with male snap connector |
| Materials: | - Top cover material
- Electrically conductive carbon cloth
- Biocompatible conductive hydrogel
- Electrode carrier liner | - Top cover material
- Electrically conductive carbon cloth
- Biocompatible conductive hydrogel
- Electrode carrier liner |
| Electrode Pad Size | Rectangle Min.40×40mm; Max.40×350mm | Rectangle Min.40×40mm; Max.100×130m
m |
| | Butterfly Min.93×150mm; Max.110×150mm | Butterfly Min.55×75mm;
Max.95×165mm |
| | Round Min.Ø18mm; Max.Ø85mm | Round Min.Ø32mm; Max.Ø70mm |
| | Oval 50×78mm | Oval Min.50×120mm;
Max.100×240mm |
| -- Patient contact
area of Electrode
Pad | Round Min.254.34mm²; Max.5671.63mm² | Round Min.804mm²; Max.3846.5mm² |
| | Rectangle Min.1600mm²; Max.7000mm² | Rectangle Min.1600 mm²; Max. 13000mm² |
| | Oval 3900mm² | Oval Min.4710 mm²; Max.18840mm² |
| | Butterfly Min.6975mm²; Max.8250mm² | Butterfly Min.4125 mm²; Max.15675mm² |
| --Hydrogel
thickness | 1.0mm ±0.2mm | 1.0mm ±0.2mm |
| --Hydrogel Volume
Resistivity | 1500 ohm-cm maximum | 1500 ohm-cm maximum |
| Conductive carbon
film | PU, Conductive carbon | PU, Conductive carbon |
| Electrode | Round 415599Ω | Round 397612Ω |
6
| Impedance of | Rectangle | 421~711Ω | Rectangle | 432~624Ω | |
|---|---|---|---|---|---|
| Electrode Pad | Oval | 437~601Ω | Oval | 412~642Ω | |
| Butterfly | 451~688Ω | Butterfly | 407~616Ω | ||
| Maximum Current | |||||
| for Power Density | |||||
| @ 500 Ohms | Use Jiajian® TENS(K112288) for calculation, the Maximum R.M.S current is 13.7mAr.m.s | Use Jiajian® TENS(K112288) for | |||
| calculation, the Maximum R.M.S current is | |||||
| 13.7mAr.m.s. Calculation formulas as | |||||
| follow: | |||||
| Maximum Output Voltage: 36V@500Ω | |||||
| Pulse Duration: 60~300µS | |||||
| Waveform: Pulsed Monophasic | |||||
| Frequency: 0.5~120Hz | |||||
| $Ir.m.s= \sqrt{\frac{120Hz*30\mu s}{1000000}} *72mA$ | |||||
| 13.7 mAr.m.s | |||||
| Current Density of | |||||
| Electrode Pad (Use | |||||
| IRMS= 13.7mA for | |||||
| calculation ) | Round | Min.0.242mA/cm² | |||
| Max.5.386mA/cm² | Round | Min.0.36mA/cm² | |||
| Max.1.70mA/cm² | |||||
| Rectangle | Min.0.196mA/cm² | ||||
| Max.0.85mA/cm² | Rectangle | Min.0.11mA/cm² | |||
| Max.0.86mA/cm² | |||||
| Oval | 0.351mA/cm² | Oval | Min.0.07mA/cm² | ||
| Max.0.29mA/cm² | |||||
| Butterfly | Min.0.17mA/cm² | ||||
| Max.0.196mA/cm² | Butterfly | Min.0.09mA/cm² | |||
| Max.0.33mA/cm² | |||||
| Maximum Power | |||||
| Density of | |||||
| Electrode Pad | |||||
| (W/cm²) | Round | 0.0369W/cm² | Round | 0.0117W/cm² | |
| Rectangle | 0.006W/cm² | Rectangle | 0.0059W/cm² | ||
| Oval | 0.0024W/cm² | Oval | 0.002W/cm² | ||
| Butterfly | 0.0013W/cm² | Butterfly | 0.0023W/cm² | ||
| (FDA guidance states that a maximum average power density should be less than 0.25 watts per square centimeter of | |||||
| electrode conductive surface area to reduce the risk of thermal burns.) | |||||
| Connector retention force | |||||
| --Lead wire with | |||||
| female socket | 10.85N | 10.80N | |||
| --snap button with | |||||
| male snap | |||||
| connector | 9.61N | 9.60N | |||
| Standards met: | 1. Lead wires test per8.5.2.3 of AAMI/ANSI ES | ||||
| 60601-1; |
- Impedance test, Conformability test and Fluid
tolerance test per 201.15.101.6 and 201.15.101.7 of
ANSI AAMI IEC 60601-2-2:2009; - Impedance Test (Dispersion Test) per FDA
requirement; - Peel strength test according to manufacturer's
requirement; - Shelf life test per ASTM F1980:2016; | | | 1. Lead wires test per 8.5.2.3 of AAMI/ANSI
ES 60601-1; - Impedance test, Conformability test and
Fluid tolerance test per 201.15.101.6 and
201.15.101.7 of IEC 60601-2-2:2009 - Impedance Test (Dispersion Test) per FDA
requirement; - Peel strength test according to
manufacturer's requirement; - Shelf life test per ASTM F1980:2011; | |
| Biocompatibility | ISO10993-5:2009; | | | ISO10993-5:2009; | |
DL Adhesive Electrode;
SHAOXING DL HEALTHCARE CO., LTD
7
DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
| ISO10993-10:2010 | ISO10993-10:2010 | |
|---|---|---|
| Sterility Status: | Non-sterile | Non-sterile |
| Electrical safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI | |
| ES60601-1: 2005/(R)2012 And A1:2012 | Lead wire meets Clause 8.5.2.3 of | |
| AAMI/ANSI ES60601-1 | ||
| Other Performance | Good electrical conductivity, good adhesive | |
| property | Good electrical conductivity, good adhesive | |
| property |
*Basic technological characteristics, New device VS. Reference Predicate device (comparison of the subject and predicate hydrogels):
| New Device | Predicate Device | |
|---|---|---|
| 510(k) number | K182111 | K100418 |
| Trade Name: | DL Adhesive Electrode | Superior Starburst Reusable Self-Adhering |
| TENS/NMES/FES Stimulating Electrode | ||
| Common Name: | Cutaneous electrode | Cutaneous electrode |
| Classification Name: | Cutaneous electrode | Cutaneous electrode |
| Product Code: | GXY | GXY |
| Regulation Number: | 882.1320 | 882.1320 |
| Medical Specialty: | Neurology | Neurology |
| Device Class: | II | II |
| Indications for use: | DL Adhesive Electrode is intended to transmit | |
| electrical current to patient skin for use with | ||
| transcutaneous electrical stimulation devices. Some | ||
| common types of the stimulation devices include, | ||
| but are not limited to TENS (Transcutaneous | ||
| Electrical Nerve Stimulation) and EMS (Electrical | ||
| Muscular Stimulation). The electrode is for OTC | ||
| (Over-The -Counter) or Prescription use. | The proposed Superior Starburst Reusable | |
| Self-Adhering TENS/NMES/FES Stimulating | ||
| Electrode is intended for over-the-counter use | ||
| with transcutaneous electrical stimulation | ||
| devices to provide the conductive interface | ||
| between the stimulation device and the | ||
| patient's skin. | ||
| Body contact | Intact Skin | Intact Skin |
| Biocompatibility | Complies with requirements of ISO 10993-1, | |
| including: Cytotoxicity (ISO 10993-5), Irritation | ||
| and Sensitization (ISO 10993-10) | Complies with requirements of ISO 10993-1, | |
| including: Cytotoxicity (ISO 10993-5), | ||
| Irritation and Sensitization (ISO 10993-10) | ||
| Sterilization | Provided non-sterile | Provided non-sterile |
| Shelf life | 2 years | 3 years |
| Impedance (at 1 | ||
| MHz) | 1500 ohm-cm maximum | 1500 ohm-cm maximum |
| Stainless Steel | ||
| Adhesion | ||
| (180° peel) | 136 grams minimum(≈1.3N) | 136 grams minimum(≈1.3N) |
| Gel thickness | 1.0mm±0.2mm | 35mil(≈0.89mm) |
| Conductive material | Water (Aqua) with Inorganic Salt | Water (Aqua) with Inorganic Salt |
| Composition | Water (solvent) | |
| Glycerin ( polymerization) | ||
| Polymer (gel forming) | Water (solvent) | |
| Glycerin ( polymerization) | ||
| Polymer (gel forming) | ||
| Polyol (gel forming) | Polyol (gel forming) | |
| Amorphous Silica (gel forming) | Amorphous Silica (gel forming) | |
| Inorganic Salt (Conductive) | Inorganic Salt (Conductive) | |
| Potassium Chloride(enhancer) | Potassium Chloride(enhancer) | |
| PH | 3.0-3.5 | 3.0-3.5 |
8
DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
The Conclusions:
Based on successful biocompatibility testing of the whole Adhesive Electrode together with the conductive hydrogel, the electrical performance of the insulated lead wire components and electrode current distribution test results, Adhesive Electrode is safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.