(230 days)
- When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
- for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- to temporarily increase local blood circulation in healthy leg muscles
- to stimulate healthy muscles in order to improve and facilitate muscle performance
- to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
- to relax muscle spasm
- to increase blood flow circulation
- for prevention of retardation of disuse atrophy
- for muscle re-education
- for maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Provide quadricep strengthening
- Improve knee stability secondary to quadricep strengthening
- When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- symptomatic relief and management of chronic, intractable pain
- relief of pain associated with arthritis
- temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy. Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads.
The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator, not a study report that includes details about acceptance criteria and device performance based on a test set, expert consensus, or specific clinical outcomes for an AI/ML device. Therefore, I cannot extract the requested information.
The document discusses:
- Device Name and Regulation: Transcutaneous Electrical Nerve Stimulator, Class II medical device.
- Indications for Use: Pain relief and muscle stimulation for various conditions.
- Predicate Device: K220998, also a Transcutaneous Electrical Nerve Stimulator.
- Technical Characteristics Comparison: A detailed table comparing the subject device with the predicate device, highlighting similarities and differences in specifications like power supply, output modes, intensity levels, dimensions, materials, and compliance with voluntary standards.
- Non-Clinical Studies: Lists compliance with various IEC and ISO standards related to electrical safety, EMC, home healthcare environment, nerve and muscle stimulators, and biocompatibility (ISO 10993 series). It also mentions software verification and validation and waveform testing.
- Clinical Information: States "Not applicable."
The absence of "clinical information" indicates that the submission relies on non-clinical testing and substantial equivalence to a predicate device rather than a clinical study demonstrating performance against specific clinical acceptance criteria. There is no mention of an AI/ML component, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 10, 2023
Shenzhen Kentro Medical Electronics Co., Ltd % Yvonne Liu Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K222870
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, IPF, NYN, GZJ Dated: September 19, 2022 Received: September 22, 2022
Dear Yvonne Liu:
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.
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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/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 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-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.
Pamela D. Scott -S
Pamela D. Scott Assistant Director 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
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Indications for Use
510(k) Number (if known) K222870
Device Name
Transcutaneous Electrical Nerve Stimulator Model: KTR-4032. KTR-4012. KTR-4015. KTR-4015. KTR-4029. KTR-4027. KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039.
Indications for Use (Describe)
-
- When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
- · for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities
- (arms) and lower extremities(legs) due to strain from exercise or normal household duties
- · to relax muscle spasm
- to increase blood flow circulation
- · for prevention of retardation of disuse atrophy
- for muscle re-education
- · for maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
- When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation 2)
- (TENS), it is intended to provide:
- · symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
- · temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---|---|
| Address: | 2nd Floor No 11, Shanzhuang Road, Xikeng Village, YuanshanStreet, Longgang District, Shenzhen City, Guangdong Province,China |
| Contact person: | Zewu Zhang |
| Phone number: | +86 755 3382 5998 |
| Fax number: | +86 755 3382 5996 |
| Email: | 522378976@qq.com |
| Date of summary prepared: | April 7, 2023 |
(2) Reason for submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | Transcutaneous Electrical Nerve Stimulator/ KTR-4031,KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027,KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037,KTR-4039 |
|---|---|
| Common name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter;Stimulator, Muscle, Powered, For Muscle Conditioning;Stimulator, Muscle, Powered;Stimulator, Electrical, Transcutaneous, For Arthritis;Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation number: | 21 CFR 882.5890, 890.5850 |
| Product code: | NUH, NGX, IPF, NYN, GZJ |
| Review panel: | Neurology, Physical Medicine |
| Regulation class: | Class II |
(4) Predicate device
| Predicate device | |
|---|---|
| Sponsor | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., |
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| LTD | |
|---|---|
| Device Name and Model | Transcutaneous Electrical Nerve Stimulator/ KTR-405 |
| 510(k) Number | K220998 |
| Product Code | NGX, NUH, IPF, NYN, GZJ |
| Regulation Number | 21 CFR 890.5850, 882.5890 |
| Regulation Class | II |
(5) Description/ Design of device:
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy.
Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads. Models KTR-4031, KTR-4032, KTR-4012, KTR-4015 are powered by 3AA batteries, models KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 are powered by 3.7V rechargeable lithium battery. The remote control is powered by 2AAA batteries. To start therapy, you need to install 3AA batteries to the main unit and 2AAA batteries to the remote control or ensure the lithium battery power is sufficient. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
(6) Intended use / indications:
- When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
· for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
· to temporarily increase local blood circulation in healthy leg muscles
{5}------------------------------------------------
-
· to stimulate healthy muscles in order to improve and facilitate muscle performance
· to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties -
to relax muscle spasm
-
to increase blood flow circulation
-
· for prevention of retardation of disuse atrophy
-
· for muscle re-education
-
· for maintaining or increasing range of motion
-
· Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
· Provide quadricep strengthening
-
· Improve knee stability secondary to quadricep strengthening
- When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
· temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Body electrode pads | EVA foam, carbon film, hydrogel, PET | Surface skin contact | Permanent (>30d) |
| Foot pads (for modelsKTR-4012, KTR-4015,KTR-4021, KTR-4027,KTR-4029, KTR-4031,KTR-4032, KTR-4034,KTR-4036, KTR-4039) | Silica gel | Surface skin contact | Permanent (>30d) |
| Foot pads (for modelsKTR-4026 andKTR-4037) | Stainless steel | Surface skin contact | Permanent (>30d) |
(7) Materials
We have directly purchased the electrode pads from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. Also we've conducted biocompatibility tests for foot pads and all pass. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence
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| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Trade name | Transcutaneous Electrical NerveStimulatorModel: KTR-4031, KTR-4032,KTR-4012, KTR-4015, KTR-4029,KTR-4027, KTR-4026, KTR-4021,KTR-4034, KTR-4036, KTR-4037,KTR-4039 | Transcutaneous Electrical NerveStimulatorModel: KTR-405 | / |
| 510 (k) number | Pending | K220998 | / |
| Regulationnumber | 21 CFR 882.5890, 890.5850 | 21 CFR 882.5890, 890.5850 | Same |
| Regulationdescription | Transcutaneous electrical nervestimulator for pain relief; poweredmuscle stimulator | Transcutaneous electrical nervestimulator for pain relief; poweredmuscle stimulator | Same |
| Product code | NUH, NGX, IPF, NYN, GZJ | NUH, NGX, IPF, NYN, GZJ | Same |
| Class | II | II | Same |
| Indications foruse/ Intendeduse | 1) When using Electrical MuscleStimulation, TranscutaneousElectrical Nerve Stimulator isintended:● for users with conditions ordisease that are associated withimpaired (poor) blood flow in thelegs/ ankles/ feet, the devicethrough the foot-pads is intendedfor use as an adjunctive treatment(as an addition to your existingtreatment) to temporarily reducelower extremity pain, swelling andcramping● to temporarily increase localblood circulation in healthy legmuscles● to stimulate healthy musclesin order to improve and facilitatemuscle performance● to temporarily relieve painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arms) andlower extremities (legs) due tostrain from exercise or normalhousehold duties | 2) When using Electrical MuscleStimulation, TranscutaneousElectrical Nerve Stimulator isintended:● for users with conditions ordisease that are associated withimpaired (poor) blood flow in thelegs/ ankles/ feet, the devicethrough the foot-pads is intendedfor use as an adjunctive treatment(as an addition to your existingtreatment) to temporarily reducelower extremity pain, swellingand cramping● to temporarily increase localblood circulation in healthy legmuscles● to stimulate healthymuscles in order to improve andfacilitate muscle performance● to temporarily relieve painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arms)and lower extremities (legs) dueto strain from exercise or normalhousehold duties | Same |
| to relax muscle spasm to increase blood flow circulation for prevention of retardation of disuse atrophy for muscle re-education for maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Provide quadricep strengthening Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: symptomatic relief and management of chronic, intractable pain relief of pain associated with arthritis temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties | to relax muscle spasm to increase blood flow circulation for prevention of retardation of disuse atrophy for muscle re-education for maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Provide quadricep strengthening Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: symptomatic relief and management of chronic, intractable pain relief of pain associated with arthritis temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties | ||
| Patientpopulation | Adult | Adult | Same |
| OTC orprescription | OTC | OTC | Same |
| Basic unit specification | |||
| Power supply | KTR-4031, KTR-4032, KTR-4012,KTR-4015 main unit: 4.5V DC 100mA or 3 AA batteriesKTR-4029, KTR-4027, KTR-4026,KTR-4021, KTR-4034, KTR-4036 | Adaptor Input: 100-240AC,50-60Hz, 0.2AOutput:5V, 1AUnit Input: 5V, 1A | Different |
| KTR-4037, KTR-4039 main unit:Input: 5V DC 1ABattery Capacity: 3.7V DC 2200mAh Lithium batteryRemote control: 2 AAA batteries | |||
| Leakage current | No earth leakage current | No earth leakage current | Same |
| Number of output modes | 10 | 10 | Same |
| Number of output channel | 2 | 2 | Same |
| Output intensity level | 20 | 150 | Different |
| -Synchronous or Alternating? | Synchronous | Synchronous | Same |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Same |
| Automatic Overload trip | No | No | Same |
| Automatic no-load trip | No | No | Same |
| Patient override control method | On/Off button | On/Off button | Same |
| Indicator display | Yes | Yes | Same |
| -On/Off status | Yes | Yes | |
| -Low battery | Yes | Yes | |
| -Output mode | Yes | Yes | |
| -Time to cut-off | Yes | Yes | |
| Automatic Shut Off | Yes | Yes | Same |
| Dimensions | KTR-4012, KTR-4015, KTR-4032, KTR-4034, KTR-4036, KTR-4037, KTR-4039: 350×350×68.5mmKTR-4021, KTR-4026, KTR-4027, KTR-4029, KTR-4031:365×365×68.5mm | 330 (W) x 327 (H) x 92 (D) mm | Different |
| Weight | About 1670g | 1.5Kg (Without accessories) | Different |
| Housingmaterial andconstruction | ABS | ABS | Same |
| Compliance withvoluntarystandards | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,IEC 60601-1-11,ISO10993-5;ISO10993-10 | IEC 60601-1,IEC 606061-1-2,IEC 60601-2-10,IEC 60601-1-11,ISO10993-5;ISO10993-10 | Same |
| Compliance with21CFR 882 and890 | Yes | Yes | Same |
| Output specification | |||
| Waveform | Biphasic, Pulsed symmetric,rectangular wave | Biphasic, Pulsed symmetric,rectangular wave | Same |
| Net Charge (perpulse) | 0 | 0 | Same |
| Maximum PhaseCharge (500Ω) | Footpads: 52.9µC @ 500ΩTENS pads: 7.55µC@ 500Ω | Footpads: 52.9µC @ 500ΩArthro-Kentro pads:24.18µC@ 500ΩTENS pads: 9.8µC@ 500Ω | Similar |
| MaximumAverageCurrent(500Ω) | Footpads: 8.42mA@ 500ΩTENS pads: 5.95mA@ 500Ω | Footpads: 8.31mA@ 500ΩArthro-Kentro pads:4.67mA@ 500ΩTENS pads: 6.85mA@500Ω | Similar |
| Maximumcurrent density(500Ω) | Footpads: 0.0395mA/ cm² and0.0458mA/ cm²TENS pads: 0.198mA/ cm²@ 500Ω | Footpads: 0.041mA/ cm²@ 500ΩArthro-Kentro pads: 0.039mA/cm²@ 500ΩTENS pads: 0.132mA/ cm²@500Ω | Similar |
| Maximumpower density(500Ω) | Footpads: 0.00017W/ cm² and0.00019W/ cm²TENS pads: 0.00059W/ cm² @500Ω | Footpads: 0.00017W/ cm²@ 500ΩArthro-Kentro pads: 0.00009W/cm²@ 500ΩTENS pads: 0.00045W/ cm²@500Ω | Similar |
| Pulse frequency | 1Hz-100Hz | 1Hz-100Hz (±5%) | Same |
| Pulse duration | TENS: 100-120µsEMS: 370-400µs and 950µs | TENS: 100-120µsEMS: 370-400µs and 950µs | Same |
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(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the Transcutaneous Electrical Nerve Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- A IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode pads and foot pads. We have directly purchased the electrode pads from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. The foot pads have been tested for biocompatibility by reliable third-party lab. So we have reason to believe that the electrode patches are safe for the users. The electrode pads and foot pads comply with the following standards.
- A ISO 10993-5: 2009, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10: 2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
- A ISO 10993-10: 2021, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
-
ISO 10993-23: 2021, Biological Evaluation of Medical Devices - Part 23: Tests for Irritation
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A The waveform test report has also been conducted to verify the output specifications of the device.
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(10) Clinical information
Not applicable.
(11) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that subject device Transcutaneous Electrical Nerve Stimulator is as safe, as effective and performs as well as the legally marketed predicate device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).