(119 days)
TENS:
PL-029K29, PL-029K30, and PL-029Q are 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.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen. legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). the device may also provide heat for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/light if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.
The provided text is a 510(k) Summary for the StimPlus Patch, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) with heating function. The document focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study involving human patients.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to clinical performance) cannot be extracted from this document because the submission method relies on demonstrating substantial equivalence to pre-existing, cleared devices rather than a de novo clinical performance study.
However, I can extract the information related to the non-clinical tests and the comparison of the device's technical specifications to those of its predicates, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.
Here's the breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This is achieved by showing that the subject device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. The core of this is the comparison table of technical parameters.
Table: Comparison of Subject Device (StimPlus Patch) to Predicate Devices
| Parameter | Subject Device (K200561) Performance | Primary Predicate (K162517) Performance | Secondary Predicate (K141260) Performance | Equivalence Claim |
|---|---|---|---|---|
| Intended Use | TENS: Temporary relief of pain, chronic pain, arthritis pain. PMS: Improve muscle performance, tone, strength; temporarily increase local blood circulation. Heating: Temporary relief of minor aches and pains. | TENS: Temporary relief of pain, chronic pain, arthritis pain. PMS: Improve muscle performance, tone, strength; temporarily increase local blood circulation. Heating: Temporary relief of minor aches and pains. | Temporary relief of pain associated with sore and aching muscles. | Identical |
| Prescription or OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | Rechargeable or non-rechargeable battery | Rechargeable battery | Non-rechargeable battery | Identical |
| Method of Line Current Isolation | Battery Supply | Battery Supply | Battery Supply | Identical |
| Patient Leakage Current: Normal Condition (μA) | 2.0 | 2.0 | 2.0 | Identical |
| Patient Leakage Current: Single Fault Condition (μA) | <10.0 | <10.0 | <10.0 | Identical |
| Average DC current through electrodes when device is on but no pulses are being applied (mA) | 0 | 0 | 0 | Identical |
| Number of Output Modes | PL-029K29, PL-029K30, PL-029Q: 1-8 | 8 | 8 | The program modes of the subject device are from those of the predicate device. |
| Number of Output Channels | 1-2 | 1 | 1 | Identical |
| Synchronous/Alternating? | PL-029K29, PL-029K30, PL-029Q: Synchronous | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | 1 | 1 | 1 | Identical |
| Regulated Current or Regulated Voltage? | Voltage | Voltage | Voltage | Identical |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Identical |
| Automatic Overload Trip? | No | No | No | Identical |
| Automatic No-Load Trip? | Yes | Yes | No | Identical |
| Automatic Shut Off? | Yes | Yes | Yes | Identical |
| User Override Control? | Yes | Yes | Yes | Identical |
| Indicator (On/Off) | Yes | Yes | Yes | Identical |
| Display (Low Battery?) | Yes | Yes | No | Identical |
| Display (Voltage/Current Level?) | No | No | No | Identical |
| Timer Range (minutes) | PL-029K29, PL-029K30, PL-029Q: 10~60 | PL-029K12: 10 | 15~60 | Identical |
| Compliance with Voluntary Standards? | Yes | Yes | Yes | Identical |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Identical |
| Dimensions (mm) [L x W x D] | PL-029K29: 150x80x12; PL-029K30: 80x55x20; PL-029Q: 148x81x29 | PL-029K12: 69.5x36.8x14; PL-029K13: 88.5x76.5x18.2 | 117x71x11 | The difference of dimension will not affect the safety or effectiveness. |
| Construction (Housing Materials) | Silicone & ABS | Silicone & ABS | Silicone | Identical |
| Functions and design | PL-029K29: Electrical stimulation; PL-029K30, PL-029Q: Electrical stimulation and heat | PL-029K12: Electrical stimulation; PL-029K13: Electrical stimulation and heat | Electrical stimulation | Identical |
| Maximum skin temperature | PL-029K29: N/A; PL-029K30, PL-029Q: 43°C | PL-029K12: N/A; PL-029K13: 43°C | N/A | Identical |
| Waveform | Biphasic | Biphasic | Biphasic | Identical |
| Shape | Rectangular | Rectangular | Rectangular | Identical |
| Maximum output voltage (Volts +/- 20%) at 500Ω | Varied modes listed (e.g., Mode 2: 36.4, Mode 3: 47.6, etc.) | Varied modes listed (e.g., Mode 2: 36.4, Mode 3: 47.6, etc.) | 71.2 | Identical or similar |
| Maximum output voltage (Volts +/- 20%) at 2KΩ | Varied modes listed | Varied modes listed | 122 | Identical or similar |
| Maximum output voltage (Volts +/- 20%) at 10KΩ | Varied modes listed (e.g., Mode 2: 134, Mode 3: 132, etc.) | Varied modes listed (e.g., Mode 2: 134, Mode 3: 132, etc.) | 146 | Identical or similar |
| Maximum output current (mA +/- 20%) at 500Ω | Varied modes listed (e.g., Mode 2: 72.8, Mode 3: 95.2, etc.) | Varied modes listed (e.g., Mode 2: 72.8, Mode 3: 95.2, etc.) | 142.4 | Identical or similar |
| Maximum output current (mA +/- 20%) at 2KΩ | Varied modes listed (e.g., Mode 2: 40.4, Mode 3: 48.0, etc.) | Varied modes listed (e.g., Mode 2: 40.4, Mode 3: 48.0, etc.) | 61 | Identical or similar |
| Pulse Width (μSec) | 100 | 100 | 50~100 | Identical or similar |
| Frequency (Hz) | Varied modes listed (e.g., Mode 2: 62.5, Mode 3: 12.8~54.3, etc.) | Varied modes listed (e.g., Mode 2: 62.5, Mode 3: 12.8~54.3, etc.) | 1.2~83.3 | Identical or similar |
| Maximum Phase charge (μC) at 500Ω | Varied modes listed (e.g., Mode 2: 14.6, Mode 3: 19.0, etc.) | Varied modes listed (e.g., Mode 2: 14.6, Mode 3: 19.0, etc.) | 33 | Identical or similar |
| Maximum current density (mA/cm²) at 500Ω | Varied modes listed (e.g., Mode 2: 2.02, Mode 3: 2.64, etc.) | Varied modes listed (e.g., Mode 2: 2.02, Mode 3: 2.64, etc.) | 8.9 | Identical or similar |
| Maximum average power density (mW/cm²) at 500Ω | Varied modes listed (e.g., Mode 2: 0.92, Mode 3: 0.32~1.37, etc.) | Varied modes listed (e.g., Mode 2: 0.92, Mode 3: 0.32~1.37, etc.) | 3.1 | Identical or similar |
| Burst Mode | N/A | N/A | N/A | Identical |
| ON time (sec) | 3.4~20 | 3.4~20 | N/A | Identical |
| OFF time (sec) | 1~2.5 | 1~2.5 | N/A | Identical |
| Additional features | N/A | N/A | N/A | Identical |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical test set or data provenance in the context of human trials for the StimPlus Patch. The "tests" performed are non-clinical, focusing on electrical safety, EMC, and biocompatibility of the device itself. Data provenance for such tests is typically not a concern in the same way as it is for clinical data. The submitter is JKH Health Co., Ltd. from Shenzhen, China.
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. This is a 510(k) submission based on substantial equivalence and non-clinical testing. There is no mention of "experts" establishing ground truth for a clinical test set in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set described that would require an adjudication method.
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 TENS/PMS unit, not an AI-assisted diagnostic imaging tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical electrostimulation device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is adherence to recognized voluntary standards (e.g., IEC 60601-1, ISO 10993 series) and the technical specifications of the predicate devices. There is no clinical "ground truth" (like pathology or outcomes data) mentioned for the StimPlus Patch's performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
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July 1, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
JKH Health Co., LTD Pu Jiang General Manager 4-5F, Building 12, Hengmingzhu Industral Park, Xinqiao Tongfuyu Industrial Area Shajing, Baoan Shenzhen, Guangdong 518104 China
Re: K200561
Trade/Device Name: StimPlus Patch Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT Dated: May 12, 2020 Received: June 3, 2020
Dear Pu Jiang:
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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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
For:
Timothy Marjenin 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) K200561
Device Name StimPlus Patch
Indications for Use (Describe)
TENS:
PL-029K29, PL-029K30, and PL-029Q are 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.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen. legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
| 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
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: JKH Health Co., Ltd. (Previous name: Shenzhen Jingkehui Electronic Co., Ltd.) Address: 4-5F, Building 12, Hengmingzhu Industrial Park, Xingiao Tongfuyu Industrial Area, Shajing, Baoan, Shenzhen, China Contact Person: Pu Jiang Tel: +86-755-27926589 Fax: +86-755-29970323 Email: Bill@JKHhealth.com Date of Preparation: 02/28/2020
2. Subject Device
Trade/Device Name: StimPlus Patch Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle Stimulation (PMS) unit, and heating for pain relief, blood circulation, and muscle performance Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC)
3. Predicate device
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd.
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K141260 Clearance Date: September 17, 2014 Submitter: Shenzhen Jingkehui Electronic Co., Ltd.
4. Description of Subject Device
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). the device may also provide heat for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/light if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
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The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.
5. Indications for Use
Over-The-Counter Use:
TENS:
PL-029K29, PL-029K30, and PL-029Q are 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.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
6. Summary of Substantial Equivalence
The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| Parameter & PredicateDevice(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence | |
|---|---|---|---|---|---|
| 510(k) Number | K200561 | K162517 | K141260 | N/A | |
| Submitter/Manufacturer | JKH Health Co., Ltd.(Previous name: ShenzhenJingkehui Electronic Co.,Ltd.) | JKH Health Co., Ltd. | Shenzhen JingkehuiElectronic Co., Ltd. | Identical | |
| Device Name/Model | PL-029K29, PL-029K30,and PL-029Q | PL-029K12 and PL-029K13 | PL-029K | N/A | |
| Intended Use | TENS:PL-029K29, PL-029K30,and PL-029Q are used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, arm,and leg, due to strain fromexercise or normalhousehold and workactivities.PL-029K29, PL-029K30,and PL-029Q are alsointended for symptomaticrelief and management ofchronic, intractable pain andrelief of pain associated witharthritis.PMS:PL-029K29, PL-029K30,and PL-029Q are used tostimulate healthy muscles inorder to improve andfacilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.PL-029K29, PL-029K30,and PL-029Q are alsointended to temporarilyincrease local bloodcirculation in the healthymuscles of lower extremities.Heating:PL-029K30 and PL-029Q isintended for temporary reliefof minor aches and pains. | TENS:PL-029K12 and PL-029K13are used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, arm,and leg, due to strain fromexercise or normalhousehold and workactivities.PL-029K12 and PL-029K13are also intended forsymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis.PMS:PL-029K12 and PL-029K13are used to stimulate healthymuscles in order to improveand facilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.PL-029K12 and PL-029K13are also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities.Heating:The device of PL-029K13 isintended for temporary reliefof minor aches and pains. | To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,arm, and leg, due to strainfrom exercise or normalhousehold and workactivities. | Identical | |
| Prescription or OTC | OTC | OTC | OTC | Identical | |
| Power Source(s) | Rechargeable or non-rechargeable battery | Rechargeable battery | Non-rechargeable battery | Identical | |
| - Method of Line CurrentIsolation | Battery Supply | Battery Supply | Battery Supply | Identical | |
| - Patient Leakage Current:Normal Condition (μΑ) | 2.0 | 2.0 | 2.0 | Identical | |
| - Patient Leakage Current:Single Fault Condition(μΑ) | <10.0 | <10.0 | <10.0 | Identical | |
| Average DC currentthrough electrodes whendevice is on but no pulsesare being applied (mA) | 0 | 0 | 0 | Identical | |
| Number of Output Modes | PL-029K29: 1-8PL-029K30: 1-8PL-029Q: 1-8 | 8 | 8 | The program modes of thesubject device are fromthose of the predicatedevice. | |
| Number of Output | 1-2 | 1 | 1 | Identical | |
| Synchronous/Alternating? | PL-029K29: SynchronousPL-029K30: SynchronousPL-029Q: Synchronous | Synchronous | Synchronous | Identical | |
| -Method of ChannelIsolation | 1 | 1 | 1 | Identical | |
| Regulated Current orRegulated Voltage? | Voltage | Voltage | Voltage | Identical | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Identical | |
| Automatic Overload Trip? | No | No | No | Identical | |
| Automatic No-Load Trip? | Yes | Yes | No | Identical | |
| Automatic Shut Off? | Yes | Yes | Yes | Identical | |
| User Override Control? | Yes | Yes | Yes | Identical | |
| Indicator | On/Off | Yes | Yes | Yes | Identical |
| Display: | Low Battery? | Yes | Yes | No | Identical |
| Voltage/CurrentLevel? | No | No | No | Identical | |
| Timer Range (minutes) | PL-029K29: 10 | PL-029K12: 10 | 15~60 | Identical | |
| Compliance withVoluntary Standards? | Yes | Yes | Yes | Identical | |
| 898? | Compliance with 21 CFR | Yes | Yes | Yes | Identical |
| Dimensions (mm) [L x Wx D] | PL-029K29: 150x80x12PL-029K30: 80x55x20PL-029Q: 148x81x29 | PL-029K12: 69.5x36.8x14PL-029K13: 88.5x76.5x18.2 | 117x71x11 | The difference ofdimension will not affectthe safety or effectiveness. | |
| Construction | Housing Materials and | Silicone & ABS | Silicone & ABS | Silicone | Identical |
| Functions and design | PL-029K29: ElectricalstimulationPL-029K30: Electricalstimulation and heatPL-029Q: Electricalstimulation and heat | PL-029K12: ElectricalstimulationPL-029K13: Electricalstimulation and heat | Electrical stimulation | Identical | |
| Maximum skintemperature | PL-029K29: N/APL-029K30: 43°CPL-029Q: 43°C | PL-029K12: N/APL-029K13: 43°C | N/A | Identical | |
| Waveform | Biphasic | Biphasic | Biphasic | Identical | |
| Shape | Rectangular | Rectangular | Rectangular | Identical | |
| Maximum output voltage(Volts +/- 20%) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 36.4Mode 3: 47.6Mode 4: 57.6Mode 5: 29.6Mode 6: 29.6Mode 7: 40.8 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 36.4Mode 3: 47.6Mode 4: 57.6Mode 5: 29.6Mode 6: 29.6Mode 7: 40.8 | 71.2 | Identical or similar |
Table 1. Comparison between the subject device and the predicate device
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| Maximum output voltage(Volts +/- 20%) at 2KΩ | Mode 1: This mode cyclesthe following modes | PL-029K12:Mode 1: This mode cyclesthe following modes | 122 | Identical or similar | |||||
|---|---|---|---|---|---|---|---|---|---|
| Maximum output voltage(Volts +/- 20%) at 10kΩ | Mode 1: This mode cyclesthe following modesMode 2: 134Mode 3: 132Mode 4: 108Mode 5: 126Mode 6: 126Mode 7: 129Mode 8: 105 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 134Mode 3: 132Mode 4: 108Mode 5: 126Mode 6: 126Mode 7: 129Mode 8: 105 | 146 | Identical or similar | |||||
| Maximum output current(mA +/- 20%) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 72.8Mode 3: 95.2Mode 4: 115.2Mode 5: 59.2Mode 6: 59.2Mode 7: 81.6Mode 8: 48.0 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 72.8Mode 3: 95.2Mode 4: 115.2Mode 5: 59.2Mode 6: 59.2Mode 7: 81.6Mode 8: 48.0 | 142.4 | Identical or similar | |||||
| Maximum output current(mA +/- 20%) at 2KΩ | Mode 1: This mode cyclesthe following modesMode 2: 40.4Mode 3: 48.0Mode 4: 46.8Mode 5: 33.2Mode 6: 33.2Mode 7: 43.2Mode 8: 26.8 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 40.4Mode 3: 48.0Mode 4: 46.8Mode 5: 33.2Mode 6: 33.2Mode 7: 43.2Mode 8: 26.8 | 61 | Identical or similar | |||||
| Maximum output current(mA +/- 20%) at 10KΩ | Pulse Width (μSec) | Mode 1: This mode cyclesthe following modesMode 2: 13.4Mode 3: 13.2Mode 4: 10.8Mode 5: 12.6Mode 6: 12.6Mode 7: 12.9Mode 8: 10.5 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 13.4Mode 3: 13.2Mode 4: 10.8Mode 5: 12.6Mode 6: 12.6Mode 7: 12.9Mode 8: 10.5 | Mode 8: 10.5 | 14.6 | Identical or similar | |||
| 100 | 100 | 50~100 | Identical or similar | ||||||
| Frequency (Hz) | Mode 1: This mode cyclesthe following modesMode 2: 62.5Mode 3: 12.8~54.3Mode 4: 1.19Mode 5: 104.1Mode 6: 104.1Mode 7: 19.8Mode 8: 156.2 | PL-029K12:Mode 1: This mode cyclesthe following modesMode 2: 62.5Mode 3: 12.8~54.3Mode 4: 1.19Mode 5: 104.1Mode 6: 104.1Mode 7: 19.8Mode 8: 156.2 | 1.2~83.3 | Identical or similar | |||||
| Maximum Phase charge(μC) at 500Ω | Mode 1: This mode cyclesthe following modesMode 2: 14.6 | PL-029K12:Mode 1: This mode cyclesthe following modes | 33 | Identical or similar |
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| Mode 2: 14.6 | |||||
|---|---|---|---|---|---|
| Mode 3: 19.0 | |||||
| Mode 4: 23.0 | |||||
| Mode 5: 11.8 | |||||
| Mode 6: 11.8 | |||||
| Mode 7: 16.3 | |||||
| Mode 8: 9.6 | |||||
| Maximum current density(mA/cm²) at 500Ω | Mode 1:This mode cyclesthe following modes | PL-029K12:Mode 1:This mode cyclesthe following modes | 8.9 | Identical or similar | |
| Mode 2: 2.02Mode 3: 2.64Mode 4: 3.20Mode 5: 1.64Mode 6: 1.64Mode 7: 3.26Mode 8: 1.92 | Mode 2: 2.02Mode 3: 2.64Mode 4: 3.20Mode 5: 1.64Mode 6: 1.64Mode 7: 3.26Mode 8: 1.92 | ||||
| Maximum average powerdensity (mW/cm²) at500Ω | Mode 1: This mode cyclesthe following modes | PL-029K12:Mode 1: This mode cyclesthe following modes | 3.1 | Identical or similar | |
| Mode 2: 0.92Mode 3: 0.32~1.37Mode 4: 0.04Mode 5: 1.01Mode 6: 1.01Mode 7: 0.53Mode 8: 1.44 | Mode 2: 0.92Mode 3: 0.32~1.37Mode 4: 0.04Mode 5: 1.01Mode 6: 1.01Mode 7: 0.53Mode 8: 1.44 | ||||
| BurstMode | (a) Pulse perburst | N/A | N/A | N/A | Identical |
| (b) Burst persecond | N/A | N/A | N/A | Identical | |
| (c) Burst-duration (sec) | N/A | N/A | N/A | Identical | |
| (d) DutyCycle | N/A | N/A | N/A | Identical | |
| ON time (sec) | 3.4~20 | 3.4~20 | N/A | Identical | |
| OFF time (sec) | 1~2.5 | 1~2.5 | N/A | Identical | |
| Additional features | N/A | N/A | N/A | Identical |
7. Substantial Equivalence
As shown in the above table, the subject device and predicate device are identical or similar. The differences between the subject device in this submission and the predicate device in K162517 and K141260 do not raise any new issues of safety or effectiveness, as discussed below.
The program modes of the subject device are from those of the predicate device. Both the subject device and the predicate device have the substantially equivalent technical specifications that are within the range of FDA cleared transcutaneous electrical nerve stimulators. In addition, the output voltage, output current, phase charge, current density, and average power density are set and delivered at a oneby-one level by the user to a strong but comfortable sensation, so the output voltage, output current, phase charge, current density, and average power density delivered are therapeutically effective with either device. Therefore, the differences of maximum output voltage, maximum output current, maximum phase charge, maximum current density, and maximum average power density between the subject device and the predicate device does not raise new questions of safety or effectiveness.
As demonstrated, the ornamental differences between the subject and predicate devices do not affect the intended use or alter the fundamental technology of the device. There are no new safety or
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effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness to the predicate device.
8. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) 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".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
- (d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
- (e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Conclusion
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.
§ 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).