(101 days)
The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.
The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.
The Omron Avail (Model PM601) is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the features and performance of the predicate and reference devices, as the submission aims to demonstrate substantial equivalence. The reported device performance is then compared against these.
| Feature / Acceptance Criteria Category | Acceptance Criteria (from predicate/reference) | Reported Device Performance (Omron Avail PM601) |
|---|---|---|
| Classification | - Regulation: 21 CFR §882.5890 (Transcutaneous electrical nerve stimulator for pain relief) - Product Code: Primary: NUH, Secondary: NYN, NGX (for predicate) | - Regulation: 21 CFR §882.5890 - Product Code: Primary: NUH, Secondary: NYN |
| Indications for Use | - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household/work activities (PulseRelief, Omron Heat Pain Pro, Painmaster MCT Patch). - Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (SmartRelief). | - Relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities. - Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Tap, Shoulder, Arm or Leg mode). |
| Environment of Use | Clinics, hospital, and home environments (Omron Heat Pain Pro); Home (PulseRelief, Painmaster MCT Patch). | Clinics, hospital and home environments. |
| Patient Population | Adults (all comparing devices); Over 12 years of age unless under physician supervision (Painmaster MCT Patch). | Adults. |
| Contraindications | Similar contraindications regarding pacemakers, implanted defibrillators, other implanted electronic/metallic devices (all comparing devices). Avoid placement along neck/through head for Painmaster. | Do not use if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. |
| Power Source | Rechargeable Lithium-ion battery (PulseRelief, Omron Heat Pain Pro); 3V CR2032 lithium battery (SmartRelief); Primary battery only, one-time use (Painmaster). | Rechargeable Lithium-ion battery. |
| Patient Leakage Current | <10 uA (Normal Condition), <50 uA (Single Fault Condition) for PulseRelief. | <10 uA (Normal Condition), <50 uA (Single Fault Condition). |
| Maximum Current Density (@500Ω) | TENS modes: Ranges from 0.08 to 0.44 mA/cm² r.m.s. across predicate/reference devices. Microcurrent: 0.0015 mA/cm² r.m.s. (Painmaster MCT Patch). | TENS modes: 0.03 to 0.17 mA/cm² r.m.s. Microcurrent: 0.0008 mA/cm² r.m.s. (This is well below the IEC60601-2-10:2012 limit of <2mA/cm²). |
| Maximum Average Power Density (@500Ω) | TENS modes: Ranges from ~1.9x10⁻³ to ~2.37x10⁻³ W/cm² across predicate/reference devices. Microcurrent: 2.871E-08 W/cm² (Painmaster MCT Patch). | TENS modes: 2.533E-05 to 6.769E-04 W/cm². Microcurrent: 1.398E-08 W/cm². |
| Timer Range | 1-59 minutes and continuous (PulseRelief); 30 minutes, fixed (SmartRelief, Omron Heat Pain Pro); Up to 300 hours, not adjustable (Painmaster MCT Patch). | TENS therapy: 5 to 60 minutes (in 5-minute increments). Microcurrent therapy: 30 to 180 minutes (in 30-minute increments). |
| Controlling Interface | Dedicated smartphone App (PulseRelief). | Dedicated Omron TENS iOS or Android App. |
| Number of Output Modes | 15 TENS, 5 EMS (PulseRelief); 1 mode (SmartRelief); 9 TENS, 2 Heat Level (Omron Heat Pain Pro); 1 Microcurrent (Painmaster). | 9 TENS modes, 1 Microcurrent mode. |
| Safety and EMC Standards | ES 60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-5/10 (PulseRelief). | ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. (Biocompatibility per ISO 10993-1). |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." The evaluation for substantial equivalence was based on non-clinical (bench) testing, software verification and validation, electrical safety, electromagnetic compatibility (EMC), and biocompatibility testing, along with a comparison to predicate devices.
- Data Provenance: Not applicable, as no clinical testing was performed on human subjects for this submission. The non-clinical testing results would originate from laboratory testing in a controlled environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical testing was performed and the evaluation was based on non-clinical performance and comparison to predicate devices, there was no "ground truth" establishment by experts in the context of clinical outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. Without a clinical test set requiring expert interpretation or consensus, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states that clinical testing was not performed. The device is a TENS unit for pain relief, not a diagnostic imaging device that typically requires MRMC studies to assess reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable in the typical sense for an AI/CADe device. This device is a hardware TENS unit controlled by an app. The "performance" being evaluated is the electrical output parameters, safety features, and usability, not a diagnostic algorithm's standalone accuracy. The device itself is the "standalone" entity in terms of delivering electrical stimulation.
7. Type of Ground Truth Used
The "ground truth" in this context is established through design specifications, industry standards (e.g., IEC 60601 series, ISO 10993-1), and the performance characteristics of legally marketed predicate devices.
- Performance Verification: The device's electrical output parameters (voltage, current, pulse duration, frequency, phase charge, current density, power density) were measured and compared against established specifications and the operational ranges of predicate devices.
- Electrical Safety & EMC: Compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) serves as the ground truth for safety.
- Biocompatibility: Testing per ISO 10993-1 established that patient-contacting materials are safe.
- Software Verification and Validation: Ensures the software (the control app) functions as intended and meets its requirements.
- Usability Testing: Evaluated the user interface and overall interaction with the device in a simulated home environment to ensure safe and effective use.
8. Sample Size for the Training Set
Not applicable. As this is a hardware medical device (TENS unit) and not an AI or machine learning algorithm requiring a "training set" of data to learn from, there is no training set in the typical computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
October 19, 2017
Omron Healthcare, Inc. % Ronald Warren Senior Director, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K172079
Trade/Device Name: Avail. Model PM601 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 7, 2017 Received: July 10, 2017
Dear Ronald Warren:
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 of medical device-related 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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 (DICE) 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 (DICE) 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 2017.10.19 18:10:10 -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) K172079
Device Name Avail Model PM601
Indications for Use (Describe)
The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environments of Use: Clinics, hospital and home environments Patient Population: Adult
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) Notification K172079
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: 847-247-5626 FAX: 847-680-6269
Contact Person:
Ronald S. Warren Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-505-3926 FAX: 408-400-0856
Date Prepared: October 19, 2017
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Avail™ (Model PM601)
Generic/Common Name:
Transcutaneous Electrical Nerve Stimulator for Pain Relief
Classification:
Class II per 21CFR882.5890
Product Code:
NUH and NYN
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PREDICATE DEVICE(S) [807.92(a)(3)]
The Omron Avail™ (Model PM601) TENS device ("Avail") is substantially equivalent to the primary predicate device, the Philips Consumer Lifestyle PulseRelief (K151035) TENS, with regard to product labeling, intended use, anatomical sites, patient population. performance testing, technological characteristics and safety characteristics. In addition, the Avail device is similar to two other devices (i.e. reference devices), the Chattem, Inc. SmartRelief (K131159) TENS and the Omron Heat Pain Pro (K160115) with regard to indications for use and TENS function. The Avail is also similar to the Painmaster MCT Patch (K130114) with respect to delivery of microcurrent (low-level electrical stimulation).
DEVICE DESCRIPTION [807.92(a)(4)]
The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.
The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.
INDICATIONS FOR USE [807.92(a)(5)]
The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environments of Use: Clinics, hospital and home environments Patient Population: Adult
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
In regard to technological characteristics, the Avail device is similar to the predicate and reference TENS devices. Like the predicate PulseRelief device is paired
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and controlled by a dedicated smartphone App. The mode, treatment duration and intensity can only be controlled by the App. However, both proposed and predicate devices can be turned off by pressing the on/off button on the main unit or button on App.
The Avail device offers nine different TENS treatment modes and a microcurrent mode, whereas the PulseRelief offers fifteen TENS treatment modes and five EMS (electrical muscle stimulation modes. Seven of the nine Avail waveforms are the same as the modes for the Heat Pain Pro reference device. The Avail device also offers a microcurrent mode, which is a minor technological difference as compared to the primary predicate device. The Avail device also offers a microcurrent mode, which is a minor technological difference as compared to the primary predicate device. To address this difference, reference is made to the Painmaster MCT Patch (K130114) which uses a microcurrent low-level electrical stimulation and shares the same regulation number (21 CFR 882.5890) and product code (NUH) as the proposed Avail device. The microcurrent mode is considered a very low current TENS (rectangular biphasic waveform) delivered at a very low frequency. A comparison of the Avail waveforms to the primary predicate and reference devices was included in this 510(k) submission.
In addition, the Avail offers certain TENS modes for treatment of arthritis pain. As specified in the proposed indications for use statement, Chronic intractable pain and arthritis pain can be treated with Avail using the Tap, Shoulder, Arm or Leg Mode. This intended use is the same as the SmartRelief reference device. Although the Avail waveforms are different from the single waveform of the SmartRelief device, the electrical parameters of both are quite similar. This is due to the presence of:
- High frequency (50+) Hz for chronic pain that requires non-contracting ● stimulation modes for a comfortable smoother therapy for chronic pain therapy
- Modulation via different pulse trains to prevent muscle accommodation for both chronic pain and arthritis
- . Variation of both high and low rate pulses within the mode to address both muscle and joint pain from arthritis and various chronic pain
A detailed comparison of the Avail waveforms to the SmartRelief waveform in the context of treatment of arthritis pain was provided in this submission.
In regard to other technological characteristics, summary tables of output parameters for the Avail, predicate and reference devices were also provided in this submission. In general, the Avail output parameters fall within the range of output parameters for PulseRelief. For example, the maximum current density (mA/cm2) range for Avail is 0.0008 ~ 0.17, while the PulseRelief range is 0.12 ~ 0.44. This range is also well below the IEC60601-2-10:2012 (Clause 201.4.2) limit of less than 2mA/cm². The maximum average power density (W/cm2) range is 1.4x10 ~ 6.8x10 * for Avail, whereas the PulseRelief maximum average power density range is 1.9x10- ~ 2.36x103 .
In regard to treatment duration, the instructions for use of the PulseRelief provide no specified time duration for six treatment modes (Conventional, Thorough stimulus, Preactivity. Soft stimulus, Deep stimulus, Radiating pulse). For Avail, the selectable time duration for TENS therapy is 5 to 60 minutes (in 5 minute increments). The selectable time duration for Microcurrent therapy is 30 to 180 minutes (in 30 minute increments).
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The labeling of the Painmaster MCT Patch for microcurrent therapy indicates the device can be used continuously for up to 300 hours. Thus, the PulseRelief has higher current density, power density and longer recommended treatment time ranges compared to Avail. In this regard. Avail should be considered at least as the PulseRelief, while offering similar TENS modes for pain therapy. Further, the Avail microcurrent recommended therapy durations falls within the range recommended for the Painmaster MCT Patch.
SUBSTANTIAL EQUIVALENCE
The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic. hospital or home settings. Omron has completed comprehensive design verification testing. electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the Avail device performs as intended. The Avail also passed testing requirements for electrical safety and EMC, and the device patient-contacting were tested to demonstrate biocompatibility. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed Avail is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed Avail device, the predicate and reference devices is included in the Substantial Equivalence Table (Table 1) below.
In regard to other technological characteristics, summary tables (Tables 2. 3. 4 and 5) of output parameters for the Avail, predicate and reference devices are provided below.
PERFORMANCE DATA [807.92(b)]
All necessary non-clinical and usability testing was conducted on the Avail to confirm that the device performs as intended.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Performance verification to confirm acceptable performance of device features and functions
- . Usability testing with a representative population of study participants in a simulated home use environment
Other nonclinical safety testing included:
- . Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- . Electrical safety and electromagnetic compatibility testing
- Software verification and validation ●
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Avail meet the established specifications
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necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Avail does not raise different questions of safety or effectiveness for TENS therapy when compared to the predicate devices.
Clinical Testing Summary:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
CONCLUSIONS [807.92(b)(3)]
Based on the results from the nonclinical and usability tests performed in support of Avail, it is concluded that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate device.
SUMMARY
The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic. hospital or home settings. Omron has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation, and usability testing to ensure that the Avail device performs as intended. The A vail also passed testing requirements for electrical safety and EMC, and the device patient-contacting components were tested to demonstrate biocompatibility. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed Avail is substantially equivalent to the predicate device.
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Table 1. Substantial Equivalence Summary
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | Primary PredicateDevicePhilips PulseRelief(K151035) | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | ||
|---|---|---|---|---|---|---|---|
| Classification-Regulation | 21 CFR§882.5890,Transcutaneouselectrical nervestimulator for painrelief | 21 CFR§882.5890,Transcutaneouselectrical nervestimulator for painrelief | 21 CFR§882.5890,Transcutaneouselectrical nervestimulator for painrelief | 21 CFR§882.5890,Transcutaneouselectrical nervestimulator for painrelief | 21 CFR§882.5890,Transcutaneouselectrical nervestimulator for painrelief | No difference. Proposeddevice and predicatedevices have thesame medical deviceclassification number. | |
| Classification-Product Code | Primary: NUH -Transcutaneouselectrical nervestimulator for painreliefSecondary: NYN-Transcutaneouselectrical nervestimulator for painrelief. | Primary: NUH -Transcutaneouselectrical nervestimulator for painreliefSecondary: NGX -Stimulator, Muscle,Powered, For MuscleConditioning | Primary: NUH -Transcutaneouselectrical nervestimulator for painreliefSecondary: NYN-Transcutaneouselectrical nervestimulator for painrelief. | NUH -Transcutaneouselectrical nervestimulator for painrelief | NUH -Transcutaneouselectrical nervestimulator for painrelief | No difference. Proposeddevice and predicatedevices have thesame medical deviceproduct code. | |
| Indications for Use | The Avail is intendedfor the relief of painassociated with sore oraching muscles of thelower back, arms, legs,shoulders or feet dueto strain from exerciseor normal householdwork activities.When used for thesymptomatic relief andmanagement ofchronic, intractablepain and relief of painassociated with | The OTCTENS/EMSstimulatorPulseRelief isdesigned to be usedfor temporary reliefof pain associatedwith sore andaching muscles in theshoulder, waist, back,neck, upperextremities (arm) andlower extremities(leg) due to strainfrom exercise or | To be used fortemporary relief ofpain associatedwith sore andaching muscles dueto strain fromexercise or normalhousehold andwork activities.To be used forsymptomatic reliefand management ofchronic, intractablepain and relief ofpain associated | The Omron Heat PainPro is intended for:The relief of painassociated with soreor aching, muscles ofthe lower back, arms,legs, shoulder, or footdue to strain fromexercise or normalhousehold workactivities.Environments of Use:Clinics, hospital andhome environmentsPatient Population: | The PainmasterMCT Patch isindicated fortemporary relief ofpain associatedwith sore andaching muscles inupper and lowerextremities (armand/or leg) due tostrain from exerciseor normalhousehold andwork activities. | Similar to PulseRelief andHeat Pain Pro fortemporary relief of painwith sore and achingmuscles. Similar toSmartRelief with respect tosymptomatic relief andmanagement of chronic,intractable pain, and reliefof pain associated witharthritis. | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | |||
| Primary PredicateDevicePhilips PulseRelief(K151035) | Reference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | Reference DevicePainmaster MCTPatch (K130114) | ||||
| arthritis, choose Tap,Shoulder, Arm or Legmode.Environments of Use:Clinics, hospital andhome environmentsPatient Population:Adult | normal householdwork activities.It should be appliedto normal, healthy,dry and clean skin ofadult patients, and isto be used tostimulate healthymuscles in order toimprove and facilitatemuscle performance. | with arthritis. | Adult | ||||
| Environment of Use | Clinics, hospitals andhome environments | Home | Unknown | Clinics, hospital andhome environments | Home | Same as Heat Pain Pro,SmartRelief andPainmaster | |
| Patient Population | Adults | Adults | Adults | Adults | Over 12 years ofage, unless underphysiciansupervision | Predicate device intendedfor same population.Painmaster indicated forover 12 years of age, unlessphysician supervised. | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | |||
| Primary PredicateDevicePhilips PulseRelief(K151035) | Reference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | Reference DevicePainmaster MCTPatch (K130114) | ||||
| Contraindications/Warnings/Precautions | ContraindicationsDo not use this deviceif you have a cardiacpacemaker, implanteddefibrillator, or otherimplanted metallic orelectronic device.Such use could causeelectric shock, burns,electrical interference,or death. | ContraindicationsDo not use thisdevice with thefollowing medicaldevices:-- Implantedelectronic medicaldevices, such aspacemakers.This may causeelectric shock, burns,or death.-- Electronic lifesupport equipment,such as respirators.-- Electronic medicaldevices worn on thebody, suchaselectrocardiographs.If you use this devicetogether with otherelectronicmedical devices,these devices may notwork correctly. | ContraindicationsDo not use thisdevice if you havea cardiacpacemaker,implanteddefibrillator, orother implantedmetallic orelectronic device.Such use couldcause electricshock, burns,electricalinterference, ordeath. | ContraindicationsDo not use thisdevice if you have acardiac pacemaker,implanteddefibrillator, or otherimplanted metallic orelectronic device.Such use could causeelectric shock, burns,electricalinterference, or death. | ContraindicationsDo not use withpacemakers oranyone usingtransdermal drugdeliveryDo not placepatches along neckDo not placepatches in a waythat causes flow ofcurrent throughhead | Contraindications aresimilar for all devices. | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | |||
| Primary PredicateDevicePhilips PulseRelief(K151035) | Reference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | Reference DevicePainmaster MCTPatch (K130114) | ||||
| Single Use | Patient-contactingPads are for singlepatient use | Patient-contactingelectrodes are forsingle patient use | Unknown | Pads are for singlepatient use | Pads should onlybe used by oneperson | No difference. Proposedand predicate TENSdevices are durablemedical equipmentintended for multiple uses.Patient-contactingcomponents are for use bya single adult patient. | |
| Sterility | External contactingdevice, nonsterile | Unknown | Unknown | External contactingdevice, nonsterile | Unknown | No difference. Proposedand predicate device areprovidednonsterile. | |
| Specification/Features | |||||||
| Over-the-Counter(OTC) | Yes | Yes | Yes | Yes | Yes | No difference | |
| Power Source(s) | Rechargeable Lithium-ion battery | RechargeableLithium-ion battery | 3V CR2032lithium battery | RechargeableLithium-ion battery | Primary batteryonly. One-time use. | Same battery type as HeatPain Pro and PulseRelief | |
| Method of LineCurrent Isolation | N/A (internal powersource) | N/A | N/A | N/A (internal powersource) | N/A | No difference | |
| Patient LeakageCurrent: | --- | --- | --- | --- | --- | --- | |
| -Normal Condition(uA) | $<10$ uA | $<10$ uA | Unknown | 1 | Unspecified | Same as PulseRelief | |
| -Single FaultCondition (uA) | $<50$ uA | $<50$ uA | Unknown | 5.52 max | Unspecified | Same as PulseRelief | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | Primary PredicateDevicePhilips PulseRelief(K151035) | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | ||
| Reference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | Reference DevicePainmaster MCTPatch (K130114) | |||||
| Average DC currentthrough electrodeswhen device is onbut no pulse arebeing applied (uA) | 0 | 0 | 0 | 0 | 0 | No difference | |
| Number of outputModes | 9 TENS modes1 Microcurrent mode | 15 TENS5 EMS | 1 mode | -3 Therapies(2 TENS with HEATcombinationtherapies and 1TENS therapy)-9 TENS StimulationModes-2 Heat LevelSettings | 1 (Microcurrent) | SimilarMinor difference of thenumber of mode does notaffect safety andeffectiveness of use. | |
| Number of outputchannels | |||||||
| Synchronous orAlternating | 1ch | 1ch | 1ch | 1ch | 1ch, monophasic | No difference | |
| Method ofChannelIsolation | None | None | None | None | N/A | No difference | |
| Regulated Currentor RegulatedVoltage | Regulated Current | Regulated Current | Unknown | Regulated Current | Regulated Current | Same as Heat Pain Pro andPulseRelief | |
| Software/Firmware/MicroprocessorControl? | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes | No difference | |
| Automatic OverloadTrip? | No | Yes | Unknown | No | No | Same as Heat Pain Pro | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENS | For TENS Function | For Microcurrent | Analysis of TechnologicalDifferences | |||
| Primary PredicateDevicePhilips PulseRelief(K151035) | Reference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | Reference DevicePainmaster MCTPatch (K130114) | ||||
| Automatic No-LoadTrip? | Yes | Yes | Unknown | Yes | Yes | Same as Heat Pain Pro andPulseRelief | |
| Automatic shut Off? | Yes | Yes | Yes | Yes | Yes | No difference | |
| User over ridecontrol? | Yes, Power On/Offbutton on the deviceand in the Appsoftware | Yes, Power On/Offbutton on the deviceand in the Appsoftware | Yes, Power On/Offbutton | Yes, Power On/Offbutton | No | Same as PulseRelief | |
| Indication display | |||||||
| On/Off Status? | Yes on App and LEDindicator on main unit | Yes on App and LEDindicator on mainunit | Yes | Yes | Yes | Same as PulseRelief | |
| Low Battery? | Yes on App | Yes on App | No | Yes | No | Same as PulseRelief | |
| Voltage/CurrentLevel? | Yes on App | Yes on App | Yes | Yes | No | Same as PulseRelief | |
| Timer Range(Minutes) | 5-60minutes and30-180minutes | 1-59minutes andcontinuous | 30 minutes, fixed | 30 minutes | Not adjustable. Upto 300 hours | Similar to PulseRelief | |
| Compliance withVoluntarystandards? | ES 60601-1.IEC60601-1-2.IEC60601-2-10, IEC60601-1-11 | ES 60601-1.IEC60601-1-2,IEC60601-2-10,ISO10993-5/10 | EN 60601-1,EN60601-1-2 | ES60601-1.IEC60601-1-2,IEC60601-2-10, IEC60601-1-11 | Yes. UL260.EN60601-2 Part1A1 & A2, EN60601-2-10 Part 2-10, EN60601-1-2EMI | Same as Heat Pain Pro | |
| Compliance with 21CFR898? | N/A (no patient cable) | Yes | Unknown | Yes | N/A | Similar structure toSmartRelief | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | Primary PredicateDevicePhilips PulseRelief(K151035) | For TENS FunctionReference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | For MicrocurrentReference DevicePainmaster MCTPatch (K130114) | Analysis of TechnologicalDifferences | |
| Weight | Device: Approx. 42 g(Both units have sameweight)Pad-L: Approx. 21 gPad-M: Approx. 17.5 gCharger: Approx. 100 g | 62g(excludes electrodes) | 20g | Approx. 200g (incl.batteries) | 0.03lb. (14g) | SimilarDifference does not affectsafety and effectiveness ofuse. | |
| Dimensions(W x H x D) | Device: Approx. 60 ×72 x 15.5mm(Both units have samedimensions)Charger: Approx. 158x 90 x 20.5mmPad-L: Approx. 219 ×83.5 x 9.3mmPad-M: Approx. 180 ×79.5 x 9.3mm | 2 units, each 54 x 54x 14mm(excludes electrodes) | 64 × 38 × 13mm | 71 x 165 x 30.5mm | 1.55" x 0.29" x 1"(39.4mm x 7.4mmx 25.4mm) | SimilarDifference does not affectsafety and effectiveness ofuse. | |
| Operatingconditions | 10 to 40 °C30 to 80 %RH700 to 1060 hPa (non-condensing) | 5 to 40 °C15 to 93 %RH700 to 1060 hPa(non-condensing) | 10 to 40°C30 to 75% RH500 to 1060 hPa | 10 to 40 °C30 to 80 %RH700 to 1060 hPa(non-condensing) | 10-45 °C, 20%-90% | Same as Heat Pain Pro | |
| Charging conditions | 5 to 35 °C (non-condensing) | 5 to 40 °C15 to 93 %RH700 to 1060 hPa(non-condensing) | 10 to 40°C30 to 75% RH500 to 1060 hPa | 5 to 35 °C (non-condensing) | N/A | Same as Heat Pain Pro | |
| Storage conditions | 0 to 40 °C30 to 80 % RH (non-condensing) | 0 to 40 ℃(electrodes)and -10 to50°C(device)less than 93% RH(non-condensing)700 to 1060 hPa | -40 to 70°C10 to 90% RH500 to 1060 hPa | 0 to 40oC30 to 80 %RH700 to 1060 hPa(non-condensing) | Store patches atroom temperaturein a dry place. | Same as Heat Pain Pro | |
| Feature | Proposed DeviceOmron AvailWireless DualChannel TENSPM601 | Primary PredicateDevicePhilips PulseRelief(K151035) | For TENS FunctionReference DeviceSmartRelief(K131159) | Reference DeviceOmron Heat PainPro (K160115) | For MicrocurrentReference DevicePainmaster MCTPatch (K130114) | Analysis of TechnologicalDifferences | |
| Transportingconditions | -20 to 60 °C10 to 90 % RH (non-condensing) | 0 to 40 °C(electrodes) and -10to 50°C (device)less than 93% RH(non-condensing)700 to 1060 hPa | -40 to 70°C10 to 90% RH500 to 1060 hPa | -20 to 60 °C10 to 95% RH,700 to 1060 hPa(non-condensing) | Unknown | SimilarDifference does not affectsafety and effectiveness ofuse. | |
| Electrode style | HV-WPAD-M or HV-WPAD-LReusable | Philips Self-AdhesiveElectrodeReusable | Self-AdhesiveElectrodeReusable | PMGELReusable | CE CertifiedAttached toreusable pads | Similar to PulseRelief andSmartRelief | |
| Patient ContactAccessory | Yes | Yes | Yes | Yes | Yes | No difference |
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{16}------------------------------------------------
AVAIL™ TENS DEVICE 510(K) PREMARKET NOTIFICATION
Table 2. Output Comparison for Avail
| Parameter | PM601 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | Steady | AcupunctureLike | Knead | Tap | Lower Back | Shoulder | Joint | Leg | Arm | Microcurrent | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| @500Ω | 25.9 | 38.4 | 27.9 | 38.3 | 38.2 | 38.4 | 25.6 | 36.7 | 38.2 | 0.025 | |
| Maximum Output Voltage [V] | @2kΩ | 45.2 | 50.8 | 37.2 | 50.3 | 50.4 | 50.4 | 35.7 | 49.5 | 50.4 | 0.100 |
| @10kΩ | 59.9 | 55.2 | 40.7 | 54.9 | 55.8 | 55.8 | 39.2 | 54.6 | 55.2 | 0.500 | |
| @500Ω | 51.8 | 76.8 | 55.8 | 76.6 | 76.4 | 76.8 | 51.2 | 73.4 | 76.4 | 0.050 | |
| Maximum Output Current [mA] | @2kΩ | 22.6 | 25.4 | 18.6 | 25.2 | 25.2 | 25.2 | 17.9 | 24.8 | 25.2 | 0.050 |
| @10kΩ | 6.0 | 5.5 | 4.1 | 5.5 | 5.6 | 5.6 | 3.9 | 5.5 | 5.5 | 0.050 | |
| Duration of primary phase [µsec] | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 2500000 | |
| Pulse Duration [µsec] | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 2500000 | |
| Frequency [Hz] | 99 | 2 | 51.65 | 1-20.13 | 2-108 | 1-19 | 42.43-108 | 2-51.65 | 2-51.65 | 0.2 | |
| Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| For multiphasic waveforms only: | Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Net Charge(µC per pulse) (@500Ω) [µC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Maximum Phase Charge (@500Ω) [µC] | 4.97 | 7.37 | 5.36 | 7.35 | 7.33 | 7.37 | 4.92 | 7.05 | 7.33 | 125.00 | |
| Maximum Current Density (@500Ω) [mA/cm2] r.m.s. | 0.16 | 0.03 | 0.09 | 0.11 | 0.17 | 0.10 | 0.12 | 0.12 | 0.12 | 0.0008 | |
| Maximum Average Current (average absolute value), mA | 0.98 | 0.03 | 0.28 | 0.30 | 0.79 | 0.28 | 0.53 | 0.36 | 0.38 | 0.03 | |
| Maximum Average Power Density (@500Ω) [W/cm2] | 5.705E-04 | 2.533E-05 | 1.727E-04 | 2.537E-04 | 6.769E-04 | 2.407E-04 | 3.040E-04 | 2.988E-04 | 3.237E-04 | 1.398E-08 | |
| (a) Pulses per burst | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Burst Mode | (b) Bursts per second | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| (c) Burst duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| (d) Duty cycle: Line(b)xLine(c) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| ON Time (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
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AVAIL™ TENS DEVICE 510(K) PREMARKET NOTIFICATION
Table 3. Output Comparison for PulseRelief (K151035)
| Parameter | Philips PulseRelief K151035 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Conventional | ThoroughStimulus | Pre-Activity | Soft Stimulus | Deep Stimulus | RadiatingPulse | ContinuousBurst | SlowKneading | Mild Kneading | DeepKneading | Diffuse Burst | MixedFrequency | PulsingMassage | Deep Massage | GentleMassage | ||
| Mode of Program Name | ||||||||||||||||
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage [V] | @500Ω | 35.9 | 35.9 | 36.0 | 36.0 | 36.0 | 36.0 | 35.8 | 35.4 | 35.2 | 35.6 | 35.9 | 35.9 | 35.9 | 36.4 | 36.0 |
| @2kΩ | 74.4 | 73.9 | 74.4 | 74.3 | 74.8 | 74.3 | 73.6 | 74.3 | 73.8 | 74.2 | 74.2 | 74.4 | 74.1 | 74.2 | 74.3 | |
| @10kΩ | 76.0 | 75.8 | 76.0 | 76.5 | 76.0 | 76.0 | 75.8 | 75.7 | 75.9 | 75.8 | 76.0 | 76.7 | 75.9 | 76.0 | 76.0 | |
| Maximum Output Current [mA] | @500Ω | 71.8 | 71.8 | 72.0 | 72.0 | 72.0 | 72.0 | 71.6 | 70.8 | 70.4 | 71.2 | 71.8 | 71.8 | 71.8 | 72.8 | 72.0 |
| @2kΩ | 37.2 | 37.0 | 37.2 | 37.2 | 37.4 | 37.2 | 36.8 | 37.2 | 36.9 | 37.1 | 37.1 | 37.2 | 37.1 | 37.1 | 37.2 | |
| @10kΩ | 7.6 | 7.6 | 7.6 | 7.7 | 7.6 | 7.6 | 7.6 | 7.6 | 7.6 | 7.6 | 7.6 | 7.7 | 7.6 | 7.6 | 7.6 | |
| Duration of primary phase [μsec] | 96 | 96 | 54 | 30 | 54 | 54 | 115 | 94 | 94 | 54 | 86 | 115 | 115 | 86 | 54 | |
| Pulse Duration [μsec] | 96 | 96 | 54 | 30 | 54 | 54 | 115 | 94 | 94 | 54 | 86 | 115 | 115 | 86 | 54 | |
| Frequency [Hz] | 100 | 40 | 100 | 80 | 80 | 60 | 100 | 80 | 80 | 80 | 80 | 8-100 | 2-8 | 2-80 | 8-80 | |
| For multiphasic waveforms only: | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Net Charge(μC per pulse) (@500Ω) [μC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Maximum Phase Charge (@500Ω) [μC] | 6.89 | 6.89 | 3.89 | 2.16 | 3.89 | 3.89 | 8.23 | 6.66 | 6.62 | 3.84 | 6.17 | 8.26 | 8.26 | 6.26 | 3.89 | |
| Maximum Current Density (@500Ω) [mA/cm2] r.m.s. | 0.40 | 0.25 | 0.30 | 0.20 | 0.27 | 0.23 | 0.43 | 0.35 | 0.35 | 0.26 | 0.34 | 0.44 | 0.12 | 0.34 | 0.27 | |
| Maximum Average Current (average absolute value), mA | 1.38 | 0.55 | 0.78 | 0.35 | 0.62 | 0.47 | 1.65 | 1.06 | 1.06 | 0.62 | 0.99 | 1.65 | 0.13 | 1.00 | 0.62 | |
| Maximum Average Power Density (@500Ω) [W/cm2] | 1.980E-03 | 7.918E-04 | 1.120E-03 | 4.977E-04 | 8.958E-04 | 6.718E-04 | 2.358E-03 | 1.508E-03 | 1.491E-03 | 8.760E-04 | 1.419E-03 | 2.371E-03 | 1.897E-04 | 1.459E-03 | 8.958E-04 | |
| Burst Mode | (a) Pulses per burst | N/A | N/A | N/A | N/A | N/A | N/A | 7 | 5 | 5 | 7 | 7 | N/A | N/A | N/A | N/A |
| (b) Bursts per second | N/A | N/A | N/A | N/A | N/A | N/A | 2.00 | 1.00 | 3.00 | 2.00 | 2.00 | N/A | N/A | N/A | N/A | |
| (c) Burst duration | N/A | N/A | N/A | N/A | N/A | N/A | 0.06 | 0.05 | 0.05 | 0.08 | 0.08 | N/A | N/A | N/A | N/A | |
| (d) Duty cycle: Line(b)xLine(c) | N/A | N/A | N/A | N/A | N/A | N/A | 0.12 | 0.05 | 0.15 | 0.15 | 0.15 | N/A | N/A | N/A | N/A | |
| ON Time (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
{18}------------------------------------------------
AVAIL™ TENS DEVICE 510(K) PREMARKET NOTIFICATION
Table 4. Output Comparison for SmartRelief (K131159) and Heat Pain Pro (K160115)
| Parameter | Smart ReliefK131159 | Heat Pain Pro (PM311)K160115 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | Smart Rerief 1.0 | TAP | KNEAD | RUB | ARM | LBACK | LEG | FOOT | JOINT | SHLDR | |
| Waveform | Asymmetrical Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular - Pulse | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage [V] | @500Ω | 33.6 | 67.2 | 40.7 | 37.3 | 67.1 | 67.1 | 66.4 | 66.9 | 40.3 | 67.1 |
| @2kΩ | 64.7 | 85.6 | 56.6 | 51.2 | 86.0 | 84.0 | 85.5 | 85.9 | 56.8 | 84.8 | |
| @10kΩ | 69.6 | 95.9 | 62.4 | 56.7 | 95.7 | 94.0 | 95.5 | 95.8 | 63.1 | 95.4 | |
| Maximum Output Current [mA] | @500Ω | 67.2 | 134.4 | 81.4 | 74.6 | 134.2 | 134.2 | 132.8 | 133.8 | 80.6 | 134.2 |
| @2kΩ | 32.4 | 42.8 | 28.3 | 25.6 | 45.0 | 42.0 | 42.8 | 43.0 | 28.4 | 42.4 | |
| @10kΩ | 7.0 | 9.6 | 6.2 | 5.7 | 9.6 | 9.4 | 9.6 | 9.6 | 6.3 | 9.5 | |
| Duration of primary phase [usec] | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 | |
| Pulse Duration [usec] | 224 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | |
| Frequency [Hz] | 2.5-99.4 | 1 - 20.13 | 51.65 | 99 | 2 - 51.65 | 2 - 108 | 2 - 51.65 | 2-11 | 42.43 - 108 | 1 - 19 | |
| For multiphasic waveforms only: | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Net Charge(µC per pulse) (@500Ω) [µC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Maximum Phase Charge (@500Ω) [μC] | 2.15 | 4.30 | 2.60 | 2.39 | 4.29 | 4.29 | 4.25 | 4.28 | 2.58 | 4.29 | |
| Maximum Current Density (@500Ω) [mA/cm2] r.m.s. | 0.19 | 0.08 | 0.36 | 0.46 | 0.12 | 0.12 | 0.12 | 0.12 | 0.32 | 0.08 | |
| Maximum Average Current (average absolute value), mA | 0.21 | 0.01 | 0.40 | 0.71 | 0.03 | 0.03 | 0.03 | 0.03 | 0.16 | 0.01 | |
| Maximum Average Power Density (@500Ω) [W/cm²] | 3.552E-04 | 5.219E-09 | 5.107E-06 | 1.576E-05 | 2.081E-08 | 2.081E-08 | 2.038E-08 | 2.069E-08 | 3.379E-06 | 5.203E-09 | |
| (a) Pulses per burst | 20 | 60.4 | 222.1 | 544.5 | 60.4 | 540.0 | 258.3 | 55.0 | 324.0 | 76.0 | |
| Burst Mode | (b) Bursts per second | 5.00 | 0.32 | 0.12 | 0.09 | 0.32 | 0.10 | 0.10 | 0.19 | 0.25 | 0.20 |
| (c) Burst duration | 0.20 | 3.10 | 8.60 | 11.00 | 3.10 | 20.00 | 10.00 | 5.20 | 16.00 | 10.00 | |
| (d) Duty cycle: Line(b)xLine(c) | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 2.00 | 1.00 | 1.01 | 4.00 | 2.00 | |
| ON Time (seconds) | 0.20 | 3.00 | 7.80 | 10.50 | 3.00 | 20.00 | 9.00 | 5.00 | 11.00 | 8.00 | |
| OFF Time (seconds) | 0.00 | 0.10 | 0.80 | 0.50 | 0.10 | 0.00 | 1.00 | 0.15 | 4.00 | 2.00 | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
{19}------------------------------------------------
TABLE 5. OUTPUT COMPARISON (MICROCURRENT) FOR PAINMASTER MCT PATCH (K130114)
| Parameter | PM601K172079 | Painmaster MCTK130114 |
|---|---|---|
| Mode of Program Name | Microcurrent | Microcurrent |
| Waveform | Biphasic | Monophasic |
| Shape | Rectangular | Rectangular |
| Maximum Output Voltage [V] @500Ω | 0.025 | 0.022 |
| Maximum Output Voltage [V] @2kΩ | 0.100 | 0.084 |
| Maximum Output Voltage [V] @10kΩ | 0.500 | 0.370 |
| Maximum Output Current [mA] @500Ω | 0.050 | 0.044 |
| Maximum Output Current [mA] @2kΩ | 0.050 | 0.042 |
| Maximum Output Current [mA] @10kΩ | 0.050 | 0.037 |
| Duration of primary phase [usec] | 2500000 | 1130000 |
| Pulse Duration [usec] | 2500000 | 1130000 |
| Frequency [Hz] | 0.2 | 0.63 |
| For multiphasic waveforms only: Symmetrical phases | N/A | N/A |
| For multiphasic waveforms only: Phase Duration | N/A | N/A |
| Net Charge(µC per pulse) (@500Ω) [UC] | 0 | 49.72 |
| Maximum Phase Charge (@500Ω) [μC] | 125.00 | 49.72 |
| Maximum Current Density (@500Ω) [mA/cm2] r.m.s. | 0.0008 | 0.0015 |
| Maximum Average Current (average absolute value), mA | 0.025 | 0.031 |
| Maximum Average Power Density (@500Ω) [W/cm²] | 1.398E-08 | 2.871E-08 |
| Burst Mode (a) Pulses per burst | N/A | N/A |
| Burst Mode (b) Bursts per second | N/A | N/A |
| Burst Mode (c) Burst duration | N/A | N/A |
| Burst Mode (d) Duty cycle: Line(b)xLine(c) | N/A | N/A |
| ON Time (seconds) | N/A | N/A |
| OFF Time (seconds) | N/A | N/A |
| Additional Features | N/A | N/A |
§ 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).