(118 days)
HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.
The provided text describes the Hanarocare Reju, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria for device performance in a clinical study specifically, nor a study proving it meets such criteria in terms of efficacy on patients.
The "Performance Data" section details various engineering, electrical, biocompatibility, and usability tests, but these are about the device's technical specifications, safety, and user-friendliness, not its clinical effectiveness against specific pain relief metrics.
Therefore, the requested information elements cannot be fully extracted from the provided document.
However, I can extract the information related to the performance data and usability in a structured way:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific acceptance criteria or reported performance for clinical efficacy (e.g., pain reduction levels). Instead, it lists various tests performed and implies that the measured values meet general "criteria" for performance characteristics. The table below focuses on the tests mentioned and their objectives.
| Acceptance Criteria (Implied Objective) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Shelf Life: Maintain quality for 2 years | Passed: Visual Inspection, Gel Pad Adhesive Strength Test, Electrical Conductivity Test validated 2-year shelf life. |
| Biocompatibility: Safe for skin contact | Passed: Cytotoxicity Test (ISO 10993-5), Primary skin irritation study (ISO 10993-10), Contact Hypersensitivity (ISO 10993-10) for gel pad. |
| Electrical Safety: Meet medical standards | Passed: Evaluated according to IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-2, IEC 62366, IEC 62304 standards. |
| Physical Durability/Transport: Withstand stress | Passed: Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Vibration, Shock tests (ISTA 2014 Integrity Test Procedure 2A). |
| Material Composition: RoHS compliance | Passed: RoHS verification (IEC 62321:2008). |
| Stimulus Output Characteristics: Meet specified parameters | Passed: Performance test conducted to evaluate characteristic parameters of the stimulus output waveform; verified that measurement values meet the criteria. |
| Usability: Easy for users to operate | Passed: Usability study demonstrated "ease to use the HANAROCare ReJu." |
| Safety Feature: Cut-off output above 3kΩ resistive load | Reported: Device reduces and cuts off output (to less than 15V at open load) when detecting >3kΩ, with LED/buzzer alarm and automatic shutdown after 3 mins. This is a safety feature and does not affect performance. |
Regarding the specific questions that cannot be answered from the provided text:
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Sample size used for the test set and the data provenance:
- For the usability study: 30 users of various age, gender, and educational backgrounds.
- For other tests (shelf life, biocompatibility, electrical, physical durability, RoHS, performance test): Sample sizes are not specified.
- Data provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical effectiveness study with a "ground truth" (e.g., expert-assessed pain levels, clinical outcomes) is described. The tests are technical compliance and user experience.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical effectiveness study requiring adjudication is described.
-
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/imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. For technical tests, the "ground truth" is defined by the technical specifications and standards (e.g., IEC standards, ISO standards).
-
The sample size for the training set: Not applicable, as no machine learning or similar model requiring a training set is described.
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How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be flowing or merging together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2016
M.i.tech Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K160893
Trade/Device Name: Hanarocare Reju Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: June 10, 2016 Received: June 17, 2016
Dear Ms. Chung:
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 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
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the quality systems (OS) 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 yours, William J. Heetderks -A ----------------------------------------------------------------------------------------------------------------------------------------------------------------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) K160893
Device Name
HANAROCare ReJu
Indications for Use (Describe)
HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
| 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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510(k) Summary
(K160893)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 07/18/2016
2. Applicant / Submitter
M.I.TECH Co., Ltd. 174. Habuk 2- gil. Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do 17706, Republic of Korea Tel. +82-31-662-5645
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417. Irvine, CA 92620 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c(@LKconsultingGroup.com
4. Trade/Proprietary Name:
HANAROCare ReJu
5. Common Name:
Transcutaneous Electrical Nerve Stimulator
6. Classification:
Stimulator, Nerve, Transcutaneous, Over-the-counter (21 CFR 882.5890, Product code NUH, Neurology)
7. Device Description:
HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.
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8. Indication for use:
HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
9. Predicate Device:
-
· Primary Predicate Device: Prospera OTC TENS Electronic Pulse Massager(model: PL029) by Prospera Corporation (K122744)
-
Reference Predicate Device:
- HIVOX Electric Stimulator OTC TENS, Rapid Relief by HIVOX BIOTEK INC (K140650)
-
EasyStim TN28 OTC by EasyMed Instruments Co., Ltd. (K140168)
-
Electronic Pulse Stimulator/PL-029K by Shenzhen Jingkehui Electronic Co., Ltd. (K141260)
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10. Substantial Equivalence:
| Subject Device | Primary PredicateDevice | Reference PredicateDevice | Reference PredicateDevice | Reference PredicateDevice | Treatment Timer | 20 minutes fixed | 5min, 10min | 20 minutes fixed | 20min, 25min,30min,40mindepending on presetprogram | Not specified | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510k # | K122744 | K140650 | K140168 | K141260 | Output Waveform | Monophasic | Monophasic | Symmetrical Biphasic | Monophasicrectangular | Not specified | ||
| Manufacturer | M.I.Tech Co., Ltd. | Prospera Corporation | HIVOX BIOTEK INC | EasyMed InstrumentsCo., Ltd. | Shenzhen JingkehuiElectronic Co., Ltd. | Shape | Rectangular | Rectangular | Rectangular | Biphasic rectangular | Not specified | |
| Trade/ProprietaryName | HANAROCareReJu | Prospera OTC TENSElectronic PulseMassager(model: PL029) | HIVOX ElectricStimulator OTC TENS,Rapid Relief | EasyStim TN28_OTC | Electronic PulseStimulator/PL-029K | Housing Materials andConstruction | Retardant Polycarbonate | ABS | Silicone | ABS | Not specified | |
| Product Code | NUH | NUH, NGX | NUH | NUH | NUH | Weight(grams) | 11 | 181.4 | Not specified | 146.5 | Not specified | |
| Type of Use | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Dimensions(mm)[W x H x D] | 36 x 35 x 13.7 | 59 x 200 x 21 | 113 x 70x 10 | 66×136×30.7 | Not specified | |
| Intended Use | HANAROCareReJu isindicated for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower extremities (leg)due to strain fromexercise or normalhousehold workactivities. | To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm) andlower extremities (leg)due to strain fromexercise or normalhousehold work activities. | The HIVOX ElectricStimulator OTC TENS,Rapid Relief PennypadPP-904. is indicated fortemporary relief of painassociated with sore andaching muscles in theupper andlowerextremities (armand/or leg), and lowerback due to strainfromexercise or normalhousehold and workactivities. | It is intended for therelief of painassociated with sore oraching muscles of thelower back, arms, orlegs due to strain fromexercise or normalhousehold and workactivities. | To be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist,back,arm, and leg, due tostrain from exercise ornormal household andwork activities | MaximumOutputVoltage(volts) | @500Ω | (±10%)• Mode 1 : 64• Mode 2 : 67• Mode 3 : 59• Combination : Thismode cycles theabove modes | 49.6 | 57.6 | 68 | (±20%)• Mode 1: 46.0• Mode 2: 59.6• Mode 3: 49.2• Mode 4: 64.8• Mode 5: 37.2• Mode 6: This modecycles the abovemodes.• Mode 7: 71.2• Mode 8: 64.0 |
| Principle of Operation | to generate small pulsesof electrical current anddeliver the pulses to auser's skin throughelectrode adhesive pads | to generate small pulsesof electrical current anddeliver the pulses to auser's skin throughelectrode adhesive pads | to generate small pulsesof electrical current anddeliver the pulses to auser's skin throughelectrode adhesive pads | to generate smallpulses of electricalcurrent and deliver thepulses to a user's skinthrough electrodeadhesive pads | to generate small pulsesof electrical current anddeliver the pulses to auser's skin throughelectrode adhesive pads | @2kΩ | (±10%)• Mode 1 : 113• Mode 2 : 119• Mode 3 : 108• Combination: Thismode cycles theabove modes. | 99.2 | 89.6 | 102 | (±20%)• Mode 1: 86.4• Mode 2: 111• Mode 3: 80• Mode 4: 90.4• Mode 5: 64.8• Mode 6: This modecycles the abovemodes.• Mode 7: 122• Mode 8: 89.6 | |
| Power Source | Lithium-polymer, 3.7V | 3V Battery | CR2032 Lithium 3V | 2 Alkaline AA 1.5V(LR6) Batteries | 2pcs AAA batteries, 3V | |||||||
| Number of OutputModes | 4 | 8 | 3 | 8 | 8 | |||||||
| Number of outputchannels | 1 | 2(Synchronous/Alternating) | 1 | 2 | 2 | |||||||
| Pulse strength | 0~15 Stages | 0~10 Stages | 0~15 Stages | Not specified | Not specified |
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| @10kΩ | (±10%)<15 | 114 | 96.0 | 110 | (±20%)• Mode 1: 116• Mode 2: 146• Mode 3: 138• Mode 4: 106• Mode 5: 111• Mode 6: This mode cycles the above modes.• Mode 7: 136• Mode 8: 96.8 | |
|---|---|---|---|---|---|---|
| MaximumOutputCurrent(mA) | @500Ω | (±10%)• Mode 1 : 128• Mode 2 : 134• Mode 3 : 118• Combination: This mode cycles the above modes. | 18 | 115.2 | 113 | (±20%)• Mode 1: 92.0• Mode 2: 119.2• Mode 3: 98.4• Mode 4: 129.6• Mode 5: 74.4• Mode 6: This mode cycles the above modes.• Mode 7: 142.4• Mode 8: 128.0 |
| @2kΩ | (±10%)• Mode 1 : 57• Mode 2 : 60• Mode 3 : 54• Combination: This mode cycles the above modes. | 3.2 | 44.8 | 51 | (±20%)• Mode 1: 43.2• Mode 2: 55.5• Mode 3: 40• Mode 4: 45.2• Mode 5: 32.4• Mode 6: This mode cycles the above modes.• Mode 7: 61• Mode 8: 44.8 | |
| @10kΩ | (±10%)<15 | 0.6 | 9.6 | 11 | (±20%)• Mode 1: 11.6• Mode 2: 14.6• Mode 3: 13.8• Mode 4: 10.6• Mode 5: 11.1• Mode 6: This mode cycles the above modes.• Mode 7: 13.6• Mode 8: 9.7 | |
| Max Pulse Freq.(Hz) | (±10%)• Mode 1 : 2Hz• Mode 2: 16.7Hz• Mode 3 : 33.3Hz• Combination: This mode cycles the above modes. | 0.5~86 | 2, 5, and 40 (Fixed) | 1~150 | (±20%)• Mode 1: 54.3• Mode 2: 35.7• Mode 3: 62.5• Mode 4: 6.7• Mode 5: 83.3• Mode 6: This mode cycles the above modes.• Mode 7: 19.8• Mode 8: 1.2 | |
| Pulse period, msec | (±10%)• Mode 1 : 500• Mode 2 : 60• Mode 3 : 30• Combination: This mode cycles the above modes. | Not specified | Not specified | Not specified | 12~832 | |
| Pulse Width(μsec) | (±10%)• Mode 1 : 115• Mode 2 : 75• Mode 3 : 65• Combination: This mode cycles the above modes. | 100~200 | 200(fixed) | 50-250, in steps of 50 | 50~100 | |
| MaximumPhaseCharge(µC) | @500Ω | ((±10%)• Mode 1: 14.72• Mode 2: 10.05• Mode 3: 7.67• Combination: Thismode cycles theabove modes. | 23 | 23.04 | 20.02 | (±20%)• Mode 1: 19.9• Mode 2: 6.0• Mode 3: 4.9• Mode 4: 6.5• Mode 5: 3.7• Mode 6: This modecycles the abovemodes.• Mode 7: 33.0• Mode 8: 25.6 |
| MaximumCurrentDensity(mA/cm2,r.m.s.) | @500Ω | (±10%)<Standard Electrode:12.57cm2>• Mode 1: 0.154• Mode 2: 0.377• Mode 3: 0.437• Combination: Thismode cycles the abovemodes.<Monarch Electrode:38.09 cm2>• Mode 1: 0.051• Mode 2: 0.124• Mode 3: 0.144• Combination: Thismode cycles the abovemodes. | 1.4 | 2.828 | 0.188 | (±20%)• Mode 1: 5.75• Mode 2: 7.45• Mode 3: 6.15• Mode 4: 8.10• Mode 5: 4.65• Mode 6: This modecycles the abovemodes.• Mode 7: 8.90• Mode 8: 8.00 |
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| MaximumAveragePowerDensity(mW/cm2) | @500Ω | (±10%)<Standard Electrode:12.57cm2>• Mode 1 : 0.15• Mode 2 : 0.893• Mode 3 : 1.2• Combination: Thismode cycles the abovemodes.<Monarch Electrode:38.09 cm2>• Mode 1 : 0.049• Mode 2 : 0.295• Mode 3 : 0.396• Combination: Thismode cycles the abovemodes. | 230 | 163 | 7.52 | (±20%)• Mode 1: 3.10• Mode 2: 0.79• Mode 3: 0.95• Mode 4: 0.18• Mode 5: 0.72• Mode 6: This modecycles the abovemodes.• Mode 7: 2.91• Mode 8: 0.12 |
|---|---|---|---|---|---|---|
| ---------------------------------------------------- | ------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----- | ----- | ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The operational principle of the above listed predicate devices is to generate small pulses of electrical current and deliver the pulses to a user's skin through electrode adhesive pads such that the underlying nerves are activated with sore and aching muscles is temporarily relieved. Similarly, the operational principle of the subject device is to generate small pulses of electrical current and deliver the pulses to an ordinary user's skin through electrode adhesive pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
The table above illustrates the subject devices comparison with the predicate that the technical characteristics, features, specifications and intended use of the subject device are substantially equivalent to those of the predicate devices. The stimulation parameters of subject device are all in the range of those of predicate devices. The design differences between the subject device and the predicate devices are insignificant and does neither affect the intended use, nor alter the operational principle of the subject device.
The major difference between the subject devices is that the subject device has the safety feature of reducing and cutting off the output when it detects more than 3kΩ. If the voltage detected is more than 3kΩ resistive load, the device will determine that the electrode is not properly attached to the maximum output voltage to less than 15 V at open load. It will also alarm the user with LED light and the buzzer sound. If the condition lasts more than 3 minutes, it will automatically cut off the output and turn the device off. This feature is for safety and does not affect the performance of the
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device; therefore, based on the information provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
11. Performance Data:
- Shelf Life Test: The following shelf life has been performed to validate 2 year shelf life of the subject device.
- Visual Inspection
- Gel Pad Adhesive Strength Test
- Electrical Conductivity Test
- · Biocompatibility Test: The following biocompatibility tests for gel pad have been performed to validate the biocompatibility of the patient contacting part.
- ISO 10993-5: Cytotoxicity Test (Aggar Diffusion Assay)
- ISO 10993-10: Primary skin irritation study in rabbits (4 hour semi-occlusive application)
- ISO 10993-10: Contact Hypersensitivity in Albino Guiana Pigs Maximization Test
- The electrical tests for the subject device were evaluated in accordance with the following method and standards.
| No. | Items | Test Method / Standard |
|---|---|---|
| 1 | IEC 60601-1 General requirements for basic safety andessential performance | IEC 60601-1:2005(Third Edition) |
| 2 | IEC 60601-2-10 Particular requirements for the basicsafety and essential performance of nerve and musclestimulators | IEC 60601-2-10:2012(Second Edition) for use inconjunction with IEC 60601-1:2005(ThirdEdition) |
| 3 | IEC 60601-1-11 Medical Electrical Equipment:General requirements for basic safety and essentialperformance-Collateral Standard: Requirements formedical electrical equipment and medical electricalsystems used in the home healthcare environment | IEC 60601-1-11(First Edition): 2010 |
| 4 | IEC 60601-1-6 General requirements for safety-Collateral Standard: Usability | IEC 60601-1-6:2010(Third Edition) |
| 5 | EMC Test | IEC 60601-1-2:2007 |
| 6 | IEC 62366 Medical devices-Application of usabilityengineering to medical devices | IEC 62366:2007(First Edition) for use inconjunction with IEC 60601-1-1-6:2010 |
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| IEC 62304Medical device software-Software life-cycleprocesses | IEC 62304:2006(First Edition) | |
|---|---|---|
| 7 | IEC 62304Medical device software-Software life-cycleprocesses | IEC 62304:2006(First Edition) |
| 8 | Atmospheric Preconditioning(Ambient)Atmospheric Conditioning(Hot, Humid)Compression(Machine Apply and Release)Vibration(Fixed Displacement)Shock(Drop)Vibration(Random) | ISTA 2014 Integrity Test Procedure 2A |
| 9 | RoHS verification | IEC 62321:2008: Procedures for theDetermination of Levels ofSix RegulatedSubstances in Electrotechnical Products |
-
Performance Test:
Performance test was conducted to evaluate the characteristic parameters of the stimulus output waveform, and verify that the measurement values meet the criteria. -
Usability Study:
Thirty (30) different users of various age, gender, and educational background participated in the study was to evaluate their performance in using various functions of the HANAROCare ReJu. The test result demonstrated the ease to use the HANAROCare ReJu.
12. Conclusion:
The subject device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the HANAROCare ReJu described in this submission 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).