(102 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Digital TENS Unit is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (neck, shoulders, back, waists, arms, and legs). At the same time, the proposed TENS device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the Pad Lead Cords and Electrode Gel Pads to the uses' skin for pain relief. to the user's skin through the pad lead cords and electrode gel pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the Controller's interface of the device.
This document is a 510(k) Summary for a Digital TENS Unit (Model: 1653195). It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. As such, the document does not contain acceptance criteria or study results for device performance.
Instead, it focuses on demonstrating equivalence through comparisons of technical characteristics and compliance with recognized standards.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not define acceptance criteria for device performance nor does it report on specific device performance metrics in the way a clinical study or performance evaluation would. Instead, it presents a comparison of the subject device's specifications against those of predicate devices, along with compliance to relevant standards.
The table in the document provides specifications for the "Subject Device" (Digital TENS Unit) and several "Predicate Device" TENS units. This is a comparison of technical specifications, not acceptance criteria and performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to the safety and performance evaluation tests conducted according to various standards (Biocompatibility, EMC, Electrical Safety, Software V&V, Waveform test). It does not describe a clinical study with a test set of data, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert consensus are typically part of clinical or diagnostic performance studies, which are not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set or ground truth establishment is described, no adjudication method is mentioned.
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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. See point 3. The "ground truth" for this type of device primarily relates to meeting established electrical and safety standards for TENS devices.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of available information from the document related to "acceptance criteria" and "study":
The document details the evaluations conducted to demonstrate the safety and electrical performance of the Digital TENS Unit. These studies are not "clinical studies" in the sense of patient outcomes or diagnostic accuracy, but rather engineering and safety compliance tests.
"Acceptance Criteria" (Implied by Standards Compliance):
The implied "acceptance criteria" are the requirements set forth by the following international and FDA recognized standards:
- Biocompatibility: ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization).
- Electromagnetic Compatibility (EMC): IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests).
- Electrical Safety: IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), IEC 60601-2-10 (Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators), and 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).
- Software Verification and Validation (V&V): According to FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices."
- Waveform Test: According to FDA "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use."
The "acceptance criteria" would be that the device successfully passes all tests prescribed by these standards and guidance documents.
"Study that proves the device meets the acceptance criteria":
The document states:
"Digital TENS Unit has been evaluated the safety and performance as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Electrical safety test according to IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 standards
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use"
The statement "The technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness" serves as the concluding statement that the device has met the regulatory "acceptance criteria" for substantial equivalence.
Table of Acceptance Criteria and Reported Device "Performance" (Specifications):
While not an "acceptance criteria" in the traditional sense, the comparison table in the document provides the specifications of the subject device against the predicates. The implied "acceptance" is that these specifications are within the range or comparable to those of already approved predicate devices.
| Feature / Standard Compliance | Acceptance Criterion (Implicit: Compliance with Standard/Guidance) | Subject Device's Reported "Performance" (Specification or Test Result) |
|---|---|---|
| Biocompatibility | ISO 10993-5, ISO 10993-10 | Tested according to standards |
| EMC | IEC 60601-1-2 | Tested according to standard |
| Electrical Safety | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11 | Tested according to standards |
| Software V&V | FDA Guidance for Software Contained in Medical Devices | Tested according to guidance requirements |
| Waveform Test | FDA Guidance for OTC TENS for Pain Relief | Waveform test report conducted to verify output specifications |
| Device Name and Model | -- | Digital TENS Unit (Model: 1653195) |
| Intended Use | -- | Temporary relief of pain associated with sore and aching muscles... |
| Power Source | Comparable to predicates, safe | DC 3.7V Lithium Battery (rechargeable) |
| Patient Leakage Current | ≤10μA (Normal), ≤50μA (Single Fault) | 0.7μA (Normal), 0.7μA (Single Fault) (Meets/Exceeds predicate) |
| Number of Output Modes | -- (Comparable to predicates) | 6 |
| Number of Output Channels | -- (Comparable to predicates) | 2 (Synchronous channel isolation: No) |
| Regulated Current/Voltage | -- (Comparable to predicates) | Regulated Voltage |
| Software/Firmware/Microprocessor Control | -- (Comparable to predicates) | Yes |
| Automatic Overload Trip? | -- (Comparable to predicates) | No |
| Automatic No-Load Trip? | -- (Comparable to predicates) | Yes |
| Automatic Shut Off? | -- (Comparable to predicates) | Yes |
| User Override Control | -- (Comparable to predicates) | Yes |
| Indicator On/Off: Status? | -- (Comparable to predicates) | Yes |
| Indicator Low Battery? | -- (Comparable to predicates) | Yes |
| Timer (Min) | Range 10-60 (Comparable to predicates) | Range 10, 20, 30, 40, 50 and 60 |
| Weight | -- (Comparable to predicates; differences noted as insignificant) | 35g (1.2 oz, Battery Included) |
| Dimensions (W x H x D) | -- (Comparable to predicates; differences noted as insignificant) | 84.93mm x 43mm x 10.3 mm |
| Housing Materials | Non-toxic, durable (e.g., ABS) | ABS |
| Output Waveform | Pulsed symmetric, biphasic / Pulsed monophasic | Pulsed symmetric, biphasic / Pulsed monophasic |
| Waveform Shape | Rectangular | Rectangular |
| Maximum Output Voltage | Within safe limits, comparable to predicates | 58 V @ 500 Ω, 86 V @ 2k Ω, 142V @ 10k Ω |
| Maximum Output Current | Within safe limits, comparable to predicates | 116 mA @ 500 Ω, 43 mA @ 2k Ω, 14.2 mA @ 10k Ω |
| Pulse Width | Within therapeutic range, comparable to predicates | 94 µs |
| Pulse frequency | Within therapeutic range, comparable to predicates | 1.2~100Hz |
| Net Charge (per pulse) | 0 µC @ 500Ω (for biphasic) or comparable for monophasic | 0 µC @ 500Ω / 13.28 μC @ 500Ω |
| Maximum Phase Charge | Within safe limits, comparable to predicates | 13.28 μC @ 500Ω |
| Maximum Average Current | Within safe limits, comparable to predicates | 8.79 mA @ 500Ω |
| Maximum Current Density | Within safe limits, comparable to predicates | 0.235 mA/cm² @ 500 Ω |
| Maximum Power Density | Within safe limits, comparable to predicates | 0.029 W/cm2 @ 500 Ω |
| ON Time | 1s | 1s |
| OFF Time | 1s | 1s |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2017
Shenzhen Eapply Technology Co., Ltd Lisa Huang Business Manager 3rd Floor, 2nd Building, Hezhou New Industrial Area Xixiang Town Shenzhen City, 518000 CN
Re: K170145/S001
Trade/Device Name: Digital Tens Unit (Model: 1653195) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: March 31, 2017 Received: April 07, 2017
Dear Lisa Huang:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
William J.
Heetderks -S
Digitally signed by William J. Heetderks -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848, cn=William J. Heetderks -S
Date: 2017.04.29 17:34:11 -04'00'
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
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Indications for Use
510(k) Number (if known)
K170145 1
Device Name Digital TENS Unit (Model: 1653195)
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
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
"510(k) Summary" as required by section 807.92(c).
1. Submitter Information
- 510(k) Owner's Name: Shenzhen Eapply Technology Co., Ltd
- Establishment Registration Number: Applying
- . Address: 3rd floor, 2nd building, Hezhou New Industrial Area, Xixiang Town, Shenzhen City, Guangdong Province, China
- Postal Code: 518000 .
- Tel: +86 755 3391 9819
- . Fax: +86 755 6164 0964
- Contact Person: Lisa Huang
- Title: Business manager
- Tel: +86 755 3391 9819 ext.817
- Fax: +86 755 6164 0964
- Email: sales06@eapply.net
2. Subject Device Information
- . Digital TENS Unit (Model: 1653195) Trade Name:
- Common Name: Transcutaneous electrical nerve stimulator
- . Classification name: Transcutaneous electrical nerve stimulator for pain relief
- . Review Panel: Neurology
- . NUH Product Code:
- II Regulation Class:
- 882.5890 ● Regulation Number:
3. Predicate Device Information
| ShenzhenJingkehuiElectronic Co.LTD | Beijing ChoiceElectronic Technology Co.,Ltd. | Tyece Ltd. | IQTechnologiesInc. | |
|---|---|---|---|---|
| Sponsor | ||||
| Device Nameand Model | Electronic PulseStimulator | Electronic PulseStimulator,Model:MDTS100 | Tyece OTCTENS Device,Model SEM44 | IQTechnologies |
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| 510(k)Number | K141260 | K160508 | K150386 | K131290 |
|---|---|---|---|---|
| Product Code | NUH | NUH | NUH | NUH |
| RegulationNumber | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| RegulationClass | II | II | II | II |
2. Device Description
Digital TENS Unit is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (neck, shoulders, back, waists, arms, and legs). At the same time, the proposed TENS device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the Pad Lead Cords and Electrode Gel Pads to the uses' skin for pain relief. to the user's skin through the pad lead cords and electrode gel pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the Controller's interface of the device.
5. Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
6. Test Summary
Digital TENS Unit has been evaluated the safety and performance as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Electrical safety test according to IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 standards
- . Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- . The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use
7. Comparison to predicate device and conclusion
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The technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| ComparisonItems | SubjectDevice | Predicate Device | Remark | ||||
|---|---|---|---|---|---|---|---|
| Device Nameand Model | Digital TENSUnit | ElectronicPulseStimulator | ElectronicPulseStimulator,Model:MDTS100 | TyeceTENSModel SEM44 | OTC IQDevice, Technologies | -- | |
| 510(k)Number | Applying | K141260 | K160508 | K150386 | K131290 | -- | |
| Intended Use | To be used fortemporaryrelief of painassociatedwith sore andachingmuscles in theshoulder,waist, back,arm, and leg,due to strainfrom exerciseor normalhouseholdand workactivities. | To be used fortemporaryrelief of painassociatedwith sore andachingmuscles in theshoulder,waist, back,arm, and leg,due to strainfrom exerciseor normalhouseholdand workactivities. | The ElectronicPulseStimulatorMDTS100 isto be used fortemporaryrelief of painassociatedwith sore andachingmuscles in theshoulder,waist, back,upperextremities(arm), andlowerextremities(leg) due tostrain fromexercise ornormalhouseholdactivities. | The Tyece OTCTENS Device,Model SEM44is to be used fortemporary reliefof painassociated withsore and achingmuscles in thelower back,arms, or legsdue to strainfrom exercise ornormalhouseholdactivities. | TENS:To be used fortemporaryrelief of painassociated withsore and achingmuscles in theshoulder, waist,back, upperextremities(arm), and SElowerextremities(leg) due tostrain fromexercise ornormalhouseholdwork activities. | -- | |
| ComparisonItems | SubjectDevice | Predicate Device | Remark | ||||
| normalhousehold andworkactivities. | PMS:It is intended tobe used tostimulatehealthymuscles inorder toimprove andfacilitatemuscleperformance. | ||||||
| Basic Unit Specifications | |||||||
| PowerSource(s) | DC 3.7VLithiumBattery(rechargeable) | DC 3V, 2AAA batteries | 4.5V(batteries,3x1.5V AM) | DC 3.7V SELithiumBattery(rechargeable) | |||
| Method ofLine CurrentIsolation | Notapplicable forDC current | Not applicablefor DC current | Not applicablefor DC current | Not applicable SEfor DC current | |||
| PatientLeakageCurrent | -- | -- | -- | -- | |||
| -NormalCondition(μΑ) | 0.7<10μΑ | ≤10μΑ | Not applicable | SE | |||
| - Single FaultCondition(μΑ) | 0.7<50μΑ | ≤50μΑ | Not applicable | SE | |||
| NumberofOutput Modes | 6 | 7 | 15 | 6 | SE | ||
| ComparisonItems | SubjectDevice | Predicate Device | Remark | ||||
| Number ofOutputChannels | 2 | / | 2 | 2 | 2 | SE | |
| -SynchronousorAlternating? | Synchronous | / | Alternating | Synchronous | / | SE | |
| -Method ofChannelIsolation | No | / | No | PCB InsulationBoost Isolation | No | SE | |
| RegulatedCurrent orRegulatedVoltage? | RegulatedVoltage | / | RegulatedVoltage | RegulatedVoltage | RegulatedVoltage | SE | |
| Software/Firmware/MicroprocessorControl? | Yes | / | Yes | Yes | Yes | SE | |
| AutomaticOverloadTrip? | No | / | No | No | No | SE | |
| AutomaticNo-LoadTrip? | Yes | / | Yes | Yes | No | SE | |
| AutomaticShut Off? | Yes | / | Yes | Yes | Yes | SE | |
| User OverrideControl | Yes | / | Yes | Yes | Yes | SE | |
| Indicat -or On/O | Yes | / | Yes | Yes | Yes | SE | |
| ComparisonItems | SubjectDevice | Predicate Device | Remark | ||||
| Display ff:Status? | |||||||
| Yes | Yes | Yes | Yes | Yes | SE | ||
| LowBattery? | |||||||
| -Voltage/CurrentLevel? | Yes forVoltage | Yes | Yes | Yes for Voltage | Yes | SE | |
| Timer(Min) | Range 10, 20, 30,/40, 50 and 60 | 20 | 5-100 | 10 to 60 | SE | ||
| Weight | 35g (1.2 oz,/BatteryIncluded) | 62.3 g(2.2 oz,/BatteryExcluded) | / | SENote 1 | |||
| Dimensions(W x H x D) | 84.93mm x/43mm x10.3 mm | 661 mm x1560 mm x265 mm(2.17in. x 5.12 in. x0.87 in.) | x 135 mm x 65 mm/x x 20 mm | SENote 1 | |||
| HousingMaterials andConstruction | ABS | ABS | ABS | SE | |||
| CompliancewithVoluntaryStandards | IEC 60601-1,IEC60601-1-2,IEC 60601-2- | IEC 60601-1,IEC60601-1-2,IEC 60601-2- | IEC 60601-1,IEC60601-1-2,60601-2- | IEC 60601-1,IEC60601-1-2,60601-2- | IEC 60601-1, SEIECIEC 60601-1-2, IEC60601-2- | ||
| ComparisonItems | SubjectDevice | Predicate Device | Remark | ||||
| IEC 10,60601-1-11,ISO 10993-5and -10 | IEC 10,60601-1-11,ISO 10993-5and -10 | IEC 10,60601-1-11,ISO 10993-5and -10 | IEC 10,60601-1-11,ISO 10993-5and -10 | IEC 10,60601-1-11,ISO 10993-5and -10 | IEC10993-5 | ||
| Compliancewith 21 CFR898 | Yes | Yes | Yes | Yes | Yes | Yes | SE |
| Output Specifications | |||||||
| Waveform | Pulsedsymmetric,biphasic/Pulsedmonophasic | / | Pulsedmonophasic | Biphasic | Pulsed | SE | |
| Shape | Rectangular | / | Rectangular | Rectangular | Rectangular | SE | |
| MaximumOutputVoltage | 58 V @ 500 Ω86 V @ 2k Ω142V @ 10k Ω | 75.2V@500Ω121V @2kΩ134V@10kΩ | 150V@500Ω160V @2kΩ165V@10kΩ | 70V @500 Ω110V @2kΩ190V@10kΩ | 64V@500 Ω94,4V @2kΩ129V@10kΩ | SE | |
| MaximumOutputCurrent | 116 mA @500 Ω43 mA @ 2k Ω14.2 mA @10k Ω | 121.6 mA@500Ω60.5 mA@2kΩ13.4 mA@10kΩ | 300 mA@500Ω80 mA @2kΩ16.5 mA@10kΩ | 86 mA@50Ω23.3 mA@2KΩ3.75 mA@10KΩ | 128mA@50Ω47.2mA@2KΩ12.9mA@10KΩ | SE | |
| Pulse Width | 94 µs | 100 µs | 50~140 µs | 50~360 µs | 100 µs | SE | |
| Pulsefrequency | 1.2~100Hz | 1.2Hz~164.4Hz | 0.9Hz~82Hz | 1-150Hz | 1.2~100Hz | SE | |
| Net Charge(per pulse) | 0 µC @500Ω/ | / | 42µC@ 500Ω | 0.001 µC500Ω | 0 µC @ 500Ω | SE |
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| ComparisonItems | SubjectDevice | Predicate Device | Remark |
|---|---|---|---|
| 13.28 μC @500Ω | |||
| MaximumPhase Charge | 13.28 μC @500Ω | 31.3 μC @500Ω @ 42 μC @ 500Ω 45.4 μC @ 500Ω | 16.8 μC @ SE500Ω |
| MaximumAverageCurrent | 8.79 mA @500Ω | 2.8mA @500Ω 16.0 mA @500Ω | SE |
| MaximumCurrentDensity(r.m.s ) | 0.235mA/cm²500 Ω | 6.02mA/cm² @500Ω3.3mA/cm2@1.57"x1.57"Electrode Pad0.790mA/cm2 @500Ω | 5.12 mA SE@500Ω |
| MaximumPowerDensity | 0.029 W/cm2@ 500 Ω | 0.002 W/cm²@500 Ω0.02 W/cm²@1.57"×1.57"Electrode Pad0.00632 W/cm² @500Ω | 0.00211W/cm2@500Ω SE |
| ON Time | 1s | ≤1s2s | SE |
| OFF Time | 1s | ≤1 s2s | SE |
Comparison in Detail(s):
Note 1:
Although there are differences of weight, dimensions observed between the predicate devices and Digital TENS Unit, the differences are insignificant in the terms of safety or effectiveness.
Finial Conclusion:
The subject device "Digital TENS Unit" is Substantial Equivalent to the predicate devices.
8. Date of the summary prepared: March 22, 2017
§ 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).