(263 days)
The Transcutaneous Electrical Nerve Stimulator is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
This document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the new device, "TENStem eco basic," is substantially equivalent to a legally marketed predicate device (K112288), also a TENS device manufactured by the same company, Wuxi Jiajian Medical Instrument Co., Ltd.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate device (K112288) and the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as a comparison between the proposed device ("Modified Device") and the predicate device in the "Substantially Equivalent Comparison Conclusion" table.
| Parameter | Acceptance Criteria (Predicate Device K112288) | Reported Device Performance (TENStem eco basic) | Remark (Meeting Criteria) |
|---|---|---|---|
| Intended Use | Same | Same | Met |
| Type of Use | Prescription use | Prescription use | Met |
| Power Source(s) | 9V Battery type 6F22 | 1.5Vx4 AAA alkaline battery | Similar (Note 1) |
| Method of Line Current Isolation | NA | N/A | Met |
| Patient Leakage Current - Normal Condition (μΑ) | 2μΑ | 2μΑ | Met |
| Patient Leakage Current - Single Fault Condition (μΑ) | NA | NA | Met |
| Average DC current through electrodes when device is on but no pulses are being applied (μΑ) | <0.01μΑ | <0.01μΑ | Met |
| Number of program | 12 | 16 | Similar (Note 1) |
| Number of Output channels | 2 | 2 | Met |
| Synchronous or Alternating? | Synchronous | Synchronous | Met |
| Method of Channel Isolation | By Transformer | By Transformer | Met |
| Regulated Current or Regulated Voltage? | Voltage control | Current control | Similar (Note 2) |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Met |
| Automatic Overload Trip? | Yes | Yes | Met |
| Automatic No-Load Trip? | No | No | Met |
| Automatic Shut Off? | No | No | Met |
| User Override Control? | Yes | Yes | Met |
| Indicator/Display - On/Off Status? | Yes | Yes | Met |
| Indicator/Display - Low Battery? | Yes | Yes | Met |
| Indicator/Display - Voltage/Current Level? | Yes | Yes | Met |
| Timer Range (minutes) | 1~99 min | 10~90 min | Similar (Note 2) |
| Compliance with Voluntary Standards? | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 | Met |
| Compliance with 21 CFR 898? | Yes | Yes | Met |
| Weight (grams) | 170g without battery | Approx.96g without battery | Similar (Note 1) |
| Dimensions (mm) [W x H x D] | 114 x 59 x 27 mm | 1406428 mm | Similar (Note 1) |
| Housing Materials & Construction | ABS | ABS | Met |
| Waveform | Monophasic | Monophasic | Met |
| Shape | Rectangular | Rectangular pulse | Met |
| Maximum Output Voltage (volts) | 35V @500Ω | 30V±20% @500Ω | Similar (Note 3) |
| Maximum Output Current (specify units) | 70mA @500Ω | 60mA±20% @500Ω | Similar (Note 3) |
| Pulse width (usec) | 60-300μs±20% | 75-300μs±20% | Similar (Note 3) |
| Pulse Period (msec) | 8.33-2000ms | 8.33-1000ms | Similar (Note 3) |
| Max. pulse frequency (Hz) [or Rate (pps)] | 0.5-120Hz±20% | 1-120Hz±20% | Similar (Note 3) |
| Net Charge (µC per pulse) | 0.83μC @500Ω | 0.65μC @500Ω | Similar (Note 4) |
| Maximum Phase Charge, (µC) | 23.04µC @500Ω | 18µC @500Ω | Similar (Note 4) |
| Maximum Average Current, (mA) | 2.76mA @500Ω | 2.16mA @500Ω | Similar (Note 4) |
| Maximum Current Density, (mA/cm²r.m.s.) | 0.35mA/cm² @500Ω | 0.09mA/cm² @500Ω | Similar (Note 4) |
| Maximum Average Power Density, (mW/cm²) | 13.27mW/cm² @500Ω | 2.59mW/cm² @500Ω | Similar (Note 4) |
| Accessories | Electrodes, cables, battery | Electrodes, cables, battery | Met |
Justification for Similarities (Notes from the original document):
- Note 1: Differences in battery type, number of programs, weight, and dimensions are deemed insignificant in terms of safety or effectiveness, as the device passed relevant IEC tests and the battery is commonly used.
- Note 2: Differences in "Regulated Current or Regulated Voltage" and "Timer Range" are considered minor and do not raise new safety/effectiveness issues as both devices passed IEC 60601-1, and the timer is user-adjustable.
- Note 3: Differences in maximum output voltage/current, pulse width, pulse period, and max pulse frequency are analyzed. The proposed device's parameters are within safety limits based on calculation and passed IEC 60601-2-10 tests.
- Note 4: "Net Charge," "Maximum Phase Charge," and "Maximum Average Current" are similar and comply with IEC 60601-2-10 requirements. The proposed device's maximum average current is smaller, indicating better safety. Differences in maximum current density and maximum average power density are due to electrode area calculation but comply with IEC 60601-2-10 and the 0.25W/cm² limit respectively.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data or patient samples. The testing described is non-clinical bench testing to verify hardware specifications and compliance with safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2). The sample size for this type of testing typically refers to the number of devices tested to ensure consistent performance, which is not specified but is assumed to be an adequate number for regulatory compliance.
The data provenance is from bench tests conducted on the Transcutaneous Electrical Nerve Stimulator, presumably at a testing facility compliant with quality system regulations. The manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd. from Wuxi, Jiangsu, China. This is a retrospective comparison against an existing predicate device, as opposed to a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The "ground truth" for comparative effectiveness in a clinical context (e.g., diagnostic accuracy of an AI algorithm) is established by expert readers or pathology. Here, the "ground truth" for showing substantial equivalence relies on:
- Compliance with recognized international standards (IEC 60601 series).
- Direct comparison of technical specifications against a previously cleared device.
- Risk analysis of any noted differences.
There is no mention of human experts interpreting test results from the device in a clinical setting to establish "ground truth" for performance.
4. Adjudication Method for the Test Set
This information is not applicable. No clinical test set involving human interpretation requiring adjudication is described. The assessment here is based on objective, quantifiable engineering and electrical performance measurements against established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not including in this submission." MRMC studies are typically performed for diagnostic or prognostic devices to assess the impact of an AI algorithm on human reader performance. This device is a medical device for pain relief, whose performance is primarily evaluated through electrical parameters and safety standards, not diagnostic accuracy requiring human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context of this TENS device. "Standalone performance" or "algorithm-only performance" usually refers to the accuracy or performance of an AI algorithm independent of human intervention. This device is an electrical stimulator, not an AI-driven diagnostic or treatment planning system that would have a "standalone algorithm." Its performance is defined by its electrical output characteristics and safety.
7. The Type of Ground Truth Used
The "ground truth" used for demonstrating substantial equivalence is based on:
- Compliance with recognized international safety and performance standards: Specifically, ANSI AAMI ES60601-1, IEC 60601-2-10, and IEC 60601-1-2. These standards define the acceptable range of electrical parameters, safety features, and electromagnetic compatibility for medical electrical equipment, including TENS devices.
- Direct comparison to the technical specifications of a legally marketed predicate device (K112288): The predicate device itself serves as a "ground truth" for acceptable performance parameters for this type of device. Any deviations from the predicate are justified by showing they either fall within acceptable variations, are safer, or still comply with relevant standards.
8. The Sample Size for the Training Set
This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator, which is a hardware medical device, not a machine learning model or algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
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June 18, 2021
Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Regulatory Assurance No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China
Re: K202893
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: April 25, 2021 Received: May 17, 2021
Dear Caihong Sun:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
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) K202893
Device Name
Transcutaneous Electrical Nerve Stimulator
Indications for Use (Describe)
The Transcutaneous Electrical Nerve Stimulator is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for Jiajian. The logo is in a teal color and features the text "JIA JIAN" in a sans-serif font. A check mark is used in place of the space between the two words. Below the text is the company name in Chinese characters.
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K202893 |
|---|---|
| Date: | April 15, 2021 |
| Type of 510(k) Submission: | Special |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| No.35 Baiqiao Rd., Ehu Town, Xishan District, | |
| Wuxi, Jiangsu, China 214116 | |
| E-mail: sch@jjmed.com.cn | |
| Tel: 86 510-88745788 | |
| Contactor: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|---|---|
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator is an electrical nervestimulator indicated for use for pain relief by applying an electrical currentto electrodes on a patient's skin to treat pain. In particular, this device isindicated for use for symptomatic relief of chronic intractable pain andadjunctive treatment in the management of post surgical and post traumaticpain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator is Transcutaneous ElectricalNerve Stimulator for pain relief. The stimulator sends gentle electricalcurrent to underlying nerves and muscle group via electrodes applied onthe skin.The device has standard programs and edit programs. It is abattery-powered portable device, comprising electronic stimulatorymodule and accessories of lead wires, electrodes and battery.Two outlet sockets are used to connect skin electrodes by lead wires. Theaccessories of electrodes is 510(k) cleared device (K192568), Size:50*50mm. |
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Image /page/4/Picture/0 description: The image shows a logo for a company called JIA JIAN. The logo is in blue and features the company name in a stylized font. There is a check mark above the letters IA. Below the company name are Chinese characters.
3. Substantially Equivalent Comparison Conclusion
| Parameters | Modified Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 510(k) Number | K202893 | K112288 | -- | |
| Device Name | Transcutaneous Electrical NerveStimulator | Jiajian® TENS | -- | |
| Model | TENStem eco basic | / | -- | |
| Manufacturer | Wuxi Jiajian Medical InstrumentCo., Ltd | Wuxi Jiajian MedicalInstrument Co., Ltd | Same | |
| Intended use | Transcutaneous Electrical NerveStimulator is an electrical nervestimulator indicated for use for painrelief by applying an electricalcurrent to electrodes on a patient'sskin to treat pain. In particular, thisdevice is indicated for use forsymptomatic relief of chronicintractable pain and adjunctivetreatment in the management ofpost surgical and post traumaticpain. | Jiajian® TENS is an electricalnerve stimulator indicated foruse for pain relief by applyingan electrical current toelectrodes on a patient's skin totreat pain. In particular, thisdevice is indicated for use forsymptomatic relief of chronicintractable pain and adjunctivetreatment in the management ofpost surgical and post traumaticpain. | Same | |
| Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 9V Battery type 6F22 | SimilarNote 1 | |
| - Method of LineCurrent Isolation | N/A | NA | Same | |
| - Patient LeakageCurrent | -- | -- | ||
| - NormalCondition (μΑ) | 2μΑ | 2μΑ | Same | |
| - Single FaultCondition (μΑ) | NA | NA | ||
| Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ) | <0.01μΑ | <0.01μΑ | Same | |
| Number of program | 16 | 12 | SimilarNote 1 | |
| Number of Outputchannels: | 2 | 2 | Same | |
| - Synchronous orAlternating? | Synchronous | Synchronous | Same | |
| Method of Channel Isolation | ||||
| Regulated Current or Regulated Voltage? | By Transformer | By Transformer | Same | |
| Software/Firmware/Microprocessor Control? | Current control | Voltage control | Similar Note 2 | |
| Automatic Overload Trip? | Yes | Yes | Same | |
| Automatic No-Load Trip? | No | No | Same | |
| Automatic Shut Off? | No | No | Same | |
| User Override Control? | Yes | Yes | Same | |
| Yes | Yes | Same | ||
| Indicat or Display | On/Off Status? | Yes | Yes | Same |
| Low Battery? | Yes | Yes | Same | |
| Voltage/Current Level? | Yes | Yes | Same | |
| Timer Range (minutes) | 10~90 min | 1~99 min | Similar Note 2 | |
| Compliance with Voluntary Standards? | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Same | |
| Compliance with 21 CFR 898? | Yes | Yes | Same | |
| Weight (grams) | Approx.96g without battery | 170g without battery | Similar Note 1 | |
| Dimensions (mm) [W x H x D] | 1406428 mm | 114 x 59 x 27 mm | Similar Note 1 | |
| Housing Materials & Construction | ABS | ABS | Same | |
| Waveform | Monophasic | Monophasic | Same | |
| Shape | Rectangular pulse | Rectangular | Same | |
| Maximum Output Voltage (volts) | $30V±20% @500Ω$ | $35V @500Ω$ | ||
| Maximum Output Current (specify units) | $60mA±20% @500Ω$ | $70mA @500Ω$ | Similar | |
| Pulse width (usec) | $75-300μs±20%$ | $60-300μs±20%$ | Note 3 | |
| Pulse Period (msec) | 8.33-1000ms | 8.33-2000ms | ||
| Max. pulse frequency (Hz) [or Rate (pps)] | 1-120Hz±20% | 0.5-120Hz±20% | ||
| Net Charge (µC per pulse) | $0.65μC @500Ω$ | $0.83μC @500Ω$ | Similar Note 4 | |
| MaximumCharge, (µC) | Phase | 18µC @500Ω | 23.04µC @500Ω | |
| Maximum AverageCurrent, (mA) | 2.16mA @500Ω | 2.76mA @500Ω | ||
| Maximum CurrentDensity, (mA/cm²,r.m.s.) | 0.09mA/cm² @500Ω | 0.35mA/cm² @500Ω | ||
| Maximum AveragePower Density,(mW/cm²) | 2.59mW/cm² @500Ω | 13.27mW/cm² @500Ω | ||
| Accessories | Electrodes, cables, battery | Electrodes, cables, battery | Same |
Table 1 - TENStem eco basic Parameters
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Image /page/5/Picture/0 description: The image shows the logo for JIA JIAN, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" with a check mark above the "I", and the Chinese name is "佳健医疗" below the English name. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.
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Image /page/6/Picture/0 description: The image shows the logo for JIA JIAN, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" with a check mark above the "I" and the registered trademark symbol next to the "N". Below the English name is the Chinese name for the company, which translates to "Jia Jian Medical".
Comparison in details:
Note 1:
The proposed device has more treatment programs than the predicate device K112288, but all of the treatment programs have passed the IEC 60601-2-10 and IEC 60601-1 test codes. So, this difference will not raise any safety or effectiveness issue.
The weight, dimensions of the proposed device are a little different from the predicate device K112288, but these differences are insignificant in the terms of safety or effectiveness. Besides, the battery used is different from the predicate device, but the battery used by the proposed device is commonly used in the market. Therefore, this difference will not raise any safety or effectiveness issue.
Note 2:
The "Regulated Current or Regulated Voltage" between the proposed device and the predicate device has slight difference. But both of them have passed IEC 60601-1 test code, so this difference won't raise any new safety and effectiveness issues.
There is a little difference on treatment time range between proposed device and predicate device. But the treatment time can be adjusted by user as they want. So, the difference of treatment time range will not raise any safety or effectiveness issue.
Note 3:
There are some differences on the maximum output voltage and maximum output current between the proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and these parameters have passed IEC 60601-2-10 test codes. So these differences will not raise any new safety and effectiveness issues. Although the "Frequency range" and "Pulse width range" of the proposed device are a little different from the predicate device, but they are all compliance with IEC 60601-2-10 requirements. So, the minor differences of function will not raise any safety or effectiveness issue.
Note 4:
The "Net Charge" and "Maximum Phase Charge" of the proposed device are very similar to the predicate device, and both of them comply with IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.
The maximum average current of the proposed device is smaller than that of the predicate device which means the better safety. The maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. However, the Maximum current density complies with IEC 60601-2-10 requirements and the
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Image /page/7/Picture/0 description: The image shows a logo for a company called JIA JIAN. The logo is in blue and features the company name in large, bold letters. There is a check mark above the letters. Below the company name is the company name in Chinese characters.
Maximum average power density is within 0.25W/cm2 limit.Therefore, these differences will not raise any new safety and effectiveness issues.
Final conclusion:
The proposed device TENStem eco basic is substantial Equivalent to the predicate device K112288.
4. Non-Clinical Test Conclusion
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:
• ANSI AAMI 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 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests:
5. Clinical Test
Clinical data was not including in this submission.
6. Conclusions
The conclusions drawn from the non-clinical tests demonstrate that the subject device is substantially equivalent to the 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).