(90 days)
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
- To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance .
- To temporarily increase local blood circulation in healthy muscles.
TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
This document describes the premarket notification (510(k)) for the TENS & EMS Device (Models LY-ET-01, LY-ET-02, LY-ET-04). This filing primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and comparison, rather than clinical efficacy studies. Therefore, many of the requested elements for acceptance criteria and study proving device meets criteria (especially those related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment) are not applicable in this context.
However, based on the provided text, I can extract information related to the acceptance criteria and the non-clinical studies conducted to demonstrate the device's safety and performance in the context of electrical safety and general device functionality, as required for a TENS/EMS device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a table summarizing non-clinical performance testing. The "Acceptance criteria" column states the general requirements for the tests, and the "Test results" column indicates "Pass" for all listed tests. There are no specific quantitative performance metrics provided as acceptance criteria for the TENS/EMS functionality itself (e.g., specific pain reduction percentages), as this is a non-clinical submission relying on equivalence to a predicate device.
| Title of the test | Acceptance criteria | Test results |
|---|---|---|
| General requirements for basic safety and essential performance (IEC 60601-1:2005/AMD 1:2012/AMD 2:2020) | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2: 2014+A1:2020) | No degradation of performance was found during test or Lower than limits of measurement. | Pass |
| Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11: 2015/AMD1:2020) | The device operates normally, and can provide basic safety and essential performance. | Pass |
| Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-1-10 Edition 1.2 2020-07) | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | Pass |
| Biocompatibility testing (ISO 10993-1, -5, -10) | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | Compliance |
| Usability Testing (IEC 62366-1, IEC 60601-1-6) | The device complies with IEC 62366-1 and IEC 60601-1-6 (implied that it passed the usability evaluation). | Compliance |
| Software verification and validation testing | Documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Implied compliance with moderate level concern requirements, no specific metrics provided.) | Compliance |
2. Sample sized used for the test set and the data provenance
- Sample Size for Non-Clinical Testing: "The test sample is the final, finished product." For each listed test (General requirements, Electromagnetic disturbances, Home Healthcare environment, Nerve and muscle stimulators), the sample size is specified as "Model: LY-ET-01, LY-ET-02, LY-ET-04." This implies a representative sample of each device model was used for testing, but specific numerical quantities (e.g., N=3 of each model) are not given.
- Data Provenance: The tests are laboratory "bench testing" conducted by the manufacturer, Jiangxi Royall Smart Technology Co., Ltd. (China). The document does not specify if these were retrospective or prospective tests, but they are typically prospective tests performed to verify compliance with standards for the specific device being submitted. All cited standards (IEC, ISO) are international.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a TENS & EMS stimulator, and the testing documented is non-clinical (electrical safety, EMC, biocompatibility, usability, software V&V). There is no "ground truth" in the clinical sense (e.g., for disease diagnosis or treatment efficacy) established by experts for these types of tests. Compliance is against published international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to clinical ground truth establishment or reader studies, which were not performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic or therapeutic device. The submission is for a TENS & EMS device, demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It's a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is compliance with the requirements and limits defined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-10, IEC 60601-1-11, IEC 62366-1, ISO 10993 series).
8. The sample size for the training set
Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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May 22, 2023
Jiangxi Royall Smart Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong China
Re: K230443
Trade/Device Name: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: February 21, 2023 Received: February 21, 2023
Dear Cassie Lee:
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.
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
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542 of the Act); 21 CFR 1000-1050.
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-
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 medical devices and radiation-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,
Robert Kang -S
for Pamela 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) K230443
Device Name
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)
Indications for Use (Describe)
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
-
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
-
To stimulate healthy muscles in order to improve and facilitate muscle performance .
-
To temporarily increase local blood circulation in healthy muscles.
| 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 of K230443
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.
1. Submitter's Information
Sponsor Name: Jiangxi Royall Smart Technology Co., Ltd. Establishment Registration Number: Applying Address: Workshop 3#, Shangyou Lefeng Technology Co., Ltd., Huangbu Town, Ganzhou City, Jiangxi Province Postal code: 341200 Contact Person (including title): Shunzhou Yang (Head of Quality Division) Tel: +86 13421375258 Fax: / E-mail: shunzhou.yang@lefengmotors.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
2. Date of the summary prepared: May 18, 2023
3. Subject Device Information
Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Trade Name: TENS & EMS Device Model Name: LY-ET-01, LY-ET-02, LY-ET-04 510(K) Number: K230443 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Regulation Number: 882.5890 Regulatory Class: II
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4. Predicate Device Information
Predicate Device: Sponsor: Guangzhou Xinbo Electronic Co., Ltd. Trade Name: Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K163611 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Requlation Number: 21 CRF 882.5890
Requlation Class: II
Reference device:
Sponsor: Counter Scientific Development (GZ) Ltd Trade/Device Name: Pain Therapy System, Model PTS-II Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K150277 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN GZJ Regulation Number: 21 CRF 882.5890 Regulatory Class: II
5. Device Description
TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The
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TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
6. Intended Use / Indications for Use
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
- To be used for temporary relief of pain associated with sore and aching muscles in the upper and । lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance. -
- -To temporarily increase local blood circulation in healthy muscles.
7. Comparison to predicate device and conclusion
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Reference device | Remark | |
|---|---|---|---|---|---|
| Company | Jiangxi Royall SmartTechnology Co., Ltd. | Guangzhou XinboElectronic Co., Ltd. | Counter ScientificDevelopment (GZ) Ltd | -- | |
| Trade Name | TENS & EMS Device | Pain Therapy Device, | Pain Therapy System | -- | |
| 510(k) Number | K230443 | K163611 | K150277 | -- | |
| ClassificationName | TranscutaneousElectrical NerveStimulator For PainRelief, Over TheCounter | TranscutaneousElectrical NerveStimulator For PainRelief, Over TheCounter | TranscutaneousElectrical NerveStimulator For PainRelief, Over TheCounter | Same | |
| ClassificationProduct Code | NUH | NUH | NUH | Same | |
| SubsequentProduct Code | NYN, NGX | NYN, NGX | GZJ, NGX, NYN | Same | |
| Elements of | Subject Device | Predicate Device | Reference device | Remark | |
| Comparison | |||||
| Intended Use /Indications for Use | TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):- To be used for temporary relief of pain associated with sore and aching muscles in the upperand lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strainfrom exercise or normal household work activities by applying current to stimulate nerve. To beused for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.- To stimulate healthy muscles in order to improve and facilitate muscleperformance .- To temporarily increase local blood circulationin healthy muscles. | To be used fortemporary relief of painassociated with soreand aching muscles inthe upper and lowerback, back of the neck,upper extremities(shoulder and arm),lower extremities (legand feet) due to strainfrom exercise or normalhousehold workactivities by applyingcurrent to stimulatenerve. To be used forsymptomatic relief andmanagement of chronic,intractable pain andrelief of pain associatedwith arthritis (ChooseMode B or C).To stimulate healthymuscles in order toimprove and facilitatemuscle performance(Choose Mode A).To temporarily increaselocal blood circulation inhealthy muscles(Choose Mode A). | To be used fortemporary relief of painassociated with soreand aching muscles inthe upper and lowerback due to strain fromexercise or normalhousehold workactivities (ChooseMode A, B, or C)To be used fortemporary relief of painassociated with soreand aching muscles inthe upper extremities(Arms) due to strainfrom exercise or normalhousehold workactivities (ChooseMode A, B or C)To be used fortemporary relief of painassociated with soreand aching muscles inthe lower extremities(Legs) due to strainfrom exercise or normalhousehold workactivities (ChooseMode A, B or C)To be used forsymptomatic relief andmanagement ofchronic, intractable painand relief of painassociated with Arthritis(Choose Mode A)To stimulate healthymuscles in order toimprove and facilitatemuscle performance(Choose Mode B) | Same | |
| Regulatory Class | Class II | Class II | Class II | Same | |
| OTC or Rx | OTC | OTC | OTC | Same | |
| Power Source(s) | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | Same | |
| Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | Use resistance toisolate | Same | |
| PatientLeakageCurrent | NCSFC | DC: <1 μA | DC: 0.5 μA | N/A | SimilarNote 1 |
| DC: <1 μA | DC: 0.6 μA | N/A | |||
| Average DC | < 0.01 μA | < 0.01 μA | 0 μA | Same | |
| Elements ofComparison | Subject Device | Predicate Device | Reference device | Remark | |
| current throughelectrodes whendevice is on but nopulses are beingapplied | |||||
| Number of OutputChannels | 1 | 2 Channels: for modelsP.T.S-II,P.T.S-IIA, P.T.S-IIB;1 Channel: for modelCP-I | 2 Synchronous | SimilarNote 2 | |
| Output IntensityLevel | LY-ET-01: 5 intensitylevelsLY-ET-02: 5 intensitylevelsLY-ET-04: 15 intensitylevels | 5 steps | Not published | DifferentNote 2 | |
| Synchronous orAlternating? | Synchronous | Synchronous | Synchronous | Same | |
| Method ofChannel Isolation | Parallel connection | Parallel connection | Parallel connection | Same | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Same | |
| AutomaticOverload Trip | No | No | Not published | Same | |
| Automatic Shut Off | Yes | Yes | Not published | Same | |
| User OverrideControl | Yes | Yes | Not published | Same | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | Not published | Same |
| LowBattery | No | No | Not published | Same | |
| Voltage/CurrentLevel | No | No | Not published | Same | |
| Timer Range | LY-ET-01: 10min,20min, 40minLY-ET-02: 10min,20min, 30minLY-ET-04: 10min,20min, 40min | 10, 20, 40 min | Not published | SimilarNote 2 | |
| Weight | LY-ET-01: 95gLY-ET-02: 82gLY-ET-04: 90gElectrode:Gel Pad: 10gElectrode Foot Pad:98g | Main Unit:P.T.S-II: 75gP.T.S-IIA: 100gP.T.S-IIB: 100gCP-I: 66gElectrode:Big Patch Electrode: 40gSmall PatchElectrode:10g | Not published | SimilarNote 3 | |
| Elements ofComparison | Subject Device | Predicate Device | Reference device | Remark | |
| Insole Electrode: 200gSole Plant ElectrodeA (only for CP-I): 900gSole Plant Electrode B:920g | |||||
| Dimensions | LY-ET-01:102.8472.8420.27mmLY-ET-02:1035920mmLY-ET-04:797923.8mmElectrode:Gel Pad: 25 cm²Electrode Foot Pad:228.8 cm² | Main Unit:P.T.S-II: 110 x 78 x 20mmP.T.S-IIA: 135 x 82 x 20mmP.T.S-IIB: 135 x 82 x 20mmCP-I: 92 x 78 x 20 mmElectrode:Large Patch Electrode:120 x 80mmSmall Patch Electrode:46 x 46mmInsole Electrode: 260 x110 mmSole Plant Electrode A(only for CP-I): 450 x450 x 90 mmSole Plant Electrode B:450 x 450 x 90 mm | Not published | SimilarNote 3 | |
| Waveform | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | Positive-going, ReverseandBiphasic | Same asthepredicate | |
| Shape | Rectangular, withinterphase interval | Rectangular, withinterphase interval | Square wave | Same asthepredicate | |
| Maximum OutputVoltage | LY-ET-01: 94Vp@$500Ω$LY-ET-02: 93Vp@ $500Ω$LY-ET-04: 40Vp@ $500Ω$ | 40Vp @ $500Ω$ | 88Vp @ $500Ω$ | SimilarNote 4 | |
| LY-ET-01: 116Vp@$2kΩ$LY-ET-02: 113Vp@ $2kΩ$LY-ET-04: 61.6Vp@ $2kΩ$ | 80Vp @ $2kΩ$ | 102Vp @ $2kΩ$ | |||
| LY-ET-01: 122Vp@$10kΩ$LY-ET-02: 123Vp@$10kΩ$LY-ET-04: 65.6Vp@$10kΩ$ | 95Vp @ $10kΩ$ | 106Vp @ $10kΩ$ | |||
| Maximum OutputCurrent | LY-ET-01: 188mA@$500Ω$LY-ET-02: 186mA@$500Ω$ | 80mA @ $500Ω$ | 176mA @ $500Ω$ | SimilarNote 4 | |
| Elements ofComparison | Subject Device | Predicate Device | Reference device | Remark | |
| LY-ET-04: 80mA@500ΩLY-ET-01: 58mA@ 2kΩLY-ET-02: 56.5mA@2kΩLY-ET-04: 30.8mA@2kΩ | 40mA @ 2kΩ | 51.0mA @ 2kΩ | |||
| LY-ET-01: 12.2mA@10kΩLY-ET-02: 12.3mA@10kΩLY-ET-04: 6.56mA@10kΩ | 9.5mA @ 10kΩ | 10.6 mA @ 10kΩ | |||
| Pulse Duration | 200µs | 200µs | 170µs | Same asthepredicate | |
| Pulse Frequency | LY-ET-01: 1-136 HzLY-ET-02:1-136 HzLY-ET-04: 1-100 Hz | 13.7~48.5 Hz | 1-136 Hz | SimilarNote 4 | |
| Net Charge (perpulse) | 0µC @ 500Ω, Method:Balanced waveform | 0µC @ 500Ω, Method:Balanced waveform | 1.63 µ C @500Ω | Same asthepredicate | |
| Maximum PhaseCharge | LY-ET-01: 37.60 µC@500ΩLY-ET-02: 37.20 µC @500ΩLY-ET-04: 16.00 µC@500Ω | 19.2 µC @ 500Ω | 29.9µC @500Ω | SimilarNote 4 | |
| Maximum AverageCurrent | LY-ET-01: 2.70 mA@500ΩLY-ET-02: 3.34 mA@500ΩLY-ET-04: 3.10 mA@500Ω | 1.53 mA @ 500Ω | 2.22mA @ 500Ω | SimilarNote 4 | |
| Maximum CurrentDensity | LY-ET-01: 7.52mA/cm²@ 500ΩLY-ET-02: 7.44mA/cm²@ 500ΩLY-ET-04: 3.20mA/cm²@ 500Ω | 0.073 mA/cm² @ 500Ω | 8.31 mA/cm²@ 500Ω | SimilarNote 4 | |
| Maximum AveragePower Density | LY-ET-01: 0.1461 mW/cm² @ 500ΩLY-ET-02: 0.2227 mW/cm² @ 500ΩLY-ET-04: 0.1927 mW/cm² @ 500Ω | 0.056 mW/cm² @ 500Ω | 0.115 mW/cm² @ 500Ω | SimilarNote 4 | |
| OperatingEnvironment | Temperature: 5 | Temperature: 5 | Not published | Same | |
| StorageEnvironment | Temperature: MainUnit: -20 ~ 55°C, | Temperature: Main Unit:-20 ~ 55°C, Electrode | Not published | Same | |
| Elements ofComparison | Subject Device | Predicate Device | Reference device | Remark | |
| Electrode Pad: 10 | Pad: 10 ~ 20°CHumidity: 10 | ||||
| Biocompatibility | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | Same | |
| Electrical Safety | Comply with IEC60601-1 and IEC60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | Same | |
| EMC | Comply with IEC60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC60601-1-2 | Same |
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Comparison in Detail(s):
Note 1:
Although the "Patient Leakage Current" of the subject device is different from the predicate device, they are all in compliance with IEC 60601-1requirements for the difference will not raise any safety or effectiveness issue.
Note 2:
Although the "Number of Output Channels", "Output Intensity Level" and "Timer Range" of the subject device are little different from the predicate device, the time range of the subject device is included in the time range of the predicate device, and other only the device itself. So, the difference will not raise any safety or effectiveness issue.
Note 3:
Although the "Dimensions" and "Weight" of the subject device are little different from the predicate device, the difference will not raise any safety or effectiveness issue.
Note 4:
For the "Pulse Frequency", although the predicate device does differ, the reference device is included to demonstrate that the frequency range of subject device has been used before.
And although the "Maximum Phase Charge", "Maximum Output Voltage", "Maximum Output Current", "Maximum Average Current", "Maximum Current Density" and "Maximum Average Power Density" of the subject device are little different from the predicate device, they are all in compliance with IEC 60601-2-10 requirements for the product. Also, the reference device demonstrates that more similar values have been cleared for TENS/EMS devices.
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Therefore, the difference will not raise any safety or effectiveness issue.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) has been evaluated the safety and performance by lab bench testing as following:
| Title of the test | DeviceDescription/SampleSize | TestMethod/ApplicableStandards | Acceptancecriteria | UnexpectedResults/SignificantDeviations | Testresults |
|---|---|---|---|---|---|
| Generalrequirements forbasic safety andessentialperformance | The testsample isthe final,finishedproduct.Model: LY-ET-01, LY-ET-02, LY-ET-04 | IEC 60601-1:2005/AMD1:2012/AMD2:2020 | The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard. | NA | Pass |
| Electromagneticdisturbances | The testsample isthe final,finishedproduct.Model: LY-ET-01, LY-ET-02, LY-ET-04 | IEC 60601-1-2:2014+A1:2020 | No degradationof performancewas foundduring test orLower thanlimits ofmeasurement | NA | Pass |
| Requirementsfor medicalelectricalequipment andmedicalelectricalsystems used inthe homehealthcareenvironment. | The testsample isthe final,finishedproduct.Model: LY-ET-01, LY-ET-02, LY-ET-04 | IEC 60601-1-11:2015/AMD1:2020 | The deviceoperatesnormally, andcan providebasic safetyand essentialperformance. | NA | Pass |
| Particularrequirements forthe basic safetyand essentialperformance ofnerve and | The testsample isthe final,finishedproduct.Model: LY- | IEC 60601-1-10 Edition1.2 2020-07 | The test iscarried outunder the testmethodspecified in thestandard, and | NA | Pass |
| musclestimulators | ET-01, LY-ET-02, LY-ET-04 | the test result iswithin the testacceptancerange of thestandard. |
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Biocompatibility testing 2)
- . ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10:2010 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
3) Usability Testing
Usability testing was conducted on the TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04), the device complies with
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical device- Part 1: Application of usability
and IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability.
4) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
5) Cybersecurity
The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
8.2 Clinical Performance
Clinical testing was not performed on the device.
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9. Final Conclusion:
The subject device TENS & EMS Device has similar features as the predicate device, and the few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K163611.
§ 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).