(292 days)
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult
The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.
Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.
However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Omron Focus TENS PM710-M/-L) |
|---|---|---|
| Classification Regulation | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief |
| Product Code | NUH and NYN (Transcutaneous electrical nerve stimulator for pain relief) | Primary: NUH, Secondary: NYN |
| Indications for Use | Relief of pain associated with sore or aching muscles (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. The Quell reference device also includes temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities, and symptomatic relief and management of chronic intractable pain. | Intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. Also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. (Narrower than Avail but similar to Quell for lower extremities and chronic pain/arthritis). |
| Environments of Use | Clinics, hospital, and home environments (for predicate Avail and implied for other TENS devices) | Clinics, hospital, and home environments |
| Patient Population | Adult | Adult |
| Contraindications | Avoid use with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. | Same as predicate and reference devices regarding cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. |
| Electrical Parameters | Output parameters within the range of predicate Avail device, and within IEC60601-2-10:2012 (Clause 201.4.2) limit of <2mA/cm² for current density. Waveforms should achieve similar therapeutic outcomes. | Max current density: 0.97 mA/cm² (well below 2 mA/cm² limit). Max average power density: 7.59x10⁻³ W/cm². Waveform: Biphasic Rectangular. Pulse Duration: 60 µsec. Frequency: 1-250 Hz. Net Charge: 0 µC per pulse. |
| Treatment Duration | Selectable time ranges for TENS therapy, commonly 5-60 minutes, or 30-180 minutes, with reference devices offering 30 or 60 minutes. | Fixed timer duration for 30 minutes. (Matches R-T1 reference, within predicate range). |
| Safety Standards | Compliance with ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. | ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. |
| Biocompatibility | Patient-contacting components must demonstrate biocompatibility. | Tested to demonstrate biocompatibility. |
| Software/Firmware | Verification and validation to ensure the device performs as intended. | Software verification and validation completed. |
2. Sample Size for Test Set and Data Provenance
The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance for a clinical test set. The evaluation relies entirely on non-clinical (bench) testing and comparison to legally marketed predicate devices.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable, as no clinical test set was used to establish ground truth in this submission.
4. Adjudication Method for Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as traditional clinical studies were not performed. The submission does not discuss human reader improvement with or without AI assistance as this is a TENS device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics as a TENS unit.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, adherence to international and national standards (e.g., IEC 60601 series), and the demonstrated performance of legally marketed predicate and reference TENS devices. The "truth" is that the device's electrical outputs and functional characteristics are safe and effective by being substantially equivalent to these established devices.
8. Sample Size for the Training Set
Not applicable, as no AI model or learning algorithm is described, and no clinical "training set" was used. The device is a TENS unit, not a machine learning system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the submission.
{0}------------------------------------------------
September 7, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Omron Healthcare, Inc. % Ronald Warren Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K183215
Trade/Device Name: Focus TENS Therapy, Model PM710-M/-L Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: August 5, 2019 Received: August 6, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
Page
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang, PharmD Acting 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183215
Device Name Omron Focus TENS Model PM710-M/-L
Indications for Use (Describe)
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities.
It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Notification K183215
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 Vice President, 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: December 11, 2018
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Focus TENS Model PM710-M/-L
Generic/Common Name:
Transcutaneous Electrical Nerve Stimulator for Pain Relief
Classification:
Class II per 21CFR882.5890
Product Code:
NUH and NYN
{4}------------------------------------------------
PREDICATE DEVICE(S) [807.92(a)(3)]
The Omron Focus TENS Model PM710-M/-L ("PM710") is substantially equivalent to the predicate device, the Omron Avail Wireless Dual Channel TENS PM601 (K172079), with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. In addition, the PM710 device is also similar to two other reference devices, the Neurometrix, Inc. Quell (K152954) and the Shenzhen Roundwhale Technology Co., Ltd Model R-T1 TENS stimulator (K180956) in regard to intended use and features.
DEVICE DESCRIPTION [807.92(a)(4)]
The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee.
The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.
INDICATIONS FOR USE [807.92(a)(5)]
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities.
It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis.
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 PM710 device is similar to the predicate Avail TENS devices in respect to the intended use and indication for use. PM710 is specifically intended for relieving pain of sore or aching muscles of the leg, whereas the Avail device is intended to relieve pain with sore or aching muscles for a wider range of body sites including the lower back, arms, legs, shoulders or feet. Both PM710 and Avail are also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis, and can be used in clinics, hospitals and home for adults.
{5}------------------------------------------------
510(k) SUMMARY (CONT.)
The PM710 device offers one TENS treatment mode similar to the reference device Quell, whereas the predicate Avail device offers nine TENS treatment modes and one microcurrent mode. The waveform generated by PM710 is also different from the waveforms of the Avail system, however the electrical parameters of both are very similar. As such, the waveforms produced by PM710 and Avail can both achieve the same therapeutic outcome of "symptomatic relief and management of chronic, intractable pain as well as the discomfort associated with arthritis". This is due to the presence of:
- o 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 o and joint pain from arthritis and various chronic pain.
The composite action of the low and high rate Hz stimulation produces rhythmic muscle contractions which then produces improved local blood vessel vasodilation thus reducing edema and retained metabolites commonly occurring from excessive muscle strain to support weak/arthritic joints. In addition, it enhances the supply of fresh oxygen and nutrients that can further result in decreased discomfort.
In regard to other output characteristics, summary tables of output parameters for the PM710, predicate and reference devices are provided in this submission. In general, the PM710 output parameters fall within the range of output parameters for the predicate Avail device. For example, the maximum current density (mA/cm2) range for PM710 is 0.97, while the Avail is 0.0008 ~ 0.17 which are both 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 7.59x103 for PM710, whereas the Avail maximum average power density range is 1.4x10-8 ~ 6.8x10-4, and the reference device R-T1 TENS is 1.08x10-4~1.48x10-2, which has a closer match to PM710.
In regard to treatment duration, the PM710 offers a specified timer duration for 30 minutes. For Avail, there are two selectable time ranges for TENS therapy; 5 to 60 minutes and 30 to180 minutes, depending on the selected mode. The same time duration of 30 minutes is also offered by the reference device of R-T1. In this regard, PM710 should be considered at least as the predicate and reference devices. A comparison of the PM710 output specification to the predicate device Avail and reference device R-T1 TENS are also provided in this submission.
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 PM710 device performs as intended. The PM710 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
{6}------------------------------------------------
510(k) SUMMARY (CONT.)
of safety or effectiveness. As such, the proposed PM710 is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed PM710 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 and 4) of output parameters for the PM710, predicate and reference devices are provided below.
PERFORMANCE DATA [807.92(b)]
All necessary bench and nonclinical testing were conducted on the PM710 to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)|Nonclinical Testing Summary:
All necessary non-clinical and usability testing was conducted on the PM710 to confirm that the device performs as intended. The nonclinical, bench testing included:
- Current Consumption
- Output Waveform
- PAD Peeling-off Detection
- Function Check
- AD Voltage Detection Accuracy
- Charging Current ●
- Voltage Endurance, Insulation Resistance ●
- Battery Characteristics
- Charger:
- 0 Current Consumption
- o Voltage Endurance, Insulation Resistance
- Durability test for the connector (between the unit and pad) ●
- Dispersion ●
- Adhesion (EC12 and Cutaneous Electrode) ●
- Adhesion on Human Skin .
- Impedance for PAD
- Battery Characteristics after Drop/Vibration Testing ●
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the PM710 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the PM710 does not raise different questions of safety or effectiveness for TENS therapy when compared to the predicate device.
[807.92(b)(2)|Clinical Testing Summarv:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
{7}------------------------------------------------
510(k) SUMMARY (CONT.)
CONCLUSIONS [807.92(b)(3)]
Based on the results from the nonclinical and usability tests performed in support of PM710, 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 and predicate device are both 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 PM710 device performs as intended. The PM710 also passed testing requirements for electrical safety and EMC, and the device patientcontacting components were tested to demonstrate biocompatibility. The minor differences in 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, PM710 is substantially equivalent to the predicate device.
{8}------------------------------------------------
| 5 | |
|---|---|
| For the may be and the be do | |
| 1 |
| production and state of the program and any andSCA WANAA1 |
|---|
| A 41 Ch WAW 1 |
| And Real Property of Children1 |
| o4 |
| 200811 |
| No. of Concession, North Street, Income of the pro-1when a need soon coupe some and whenA Microsoft |
| 1of Children of Children1 |
| 1BW PS P B B B W W TNAI A1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| P11111 |
| Feature | Proposed DeviceFocus TENSPM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
|---|---|---|---|---|---|
| Classification-Regulation | 21 CFR§882.5890,Transcutaneous electricalnerve stimulator for painrelief | 21 CFR§882.5890,Transcutaneous electricalnerve stimulator for painrelief | 21 CFR§882.5890,Transcutaneous electricalnerve stimulator for painrelief | 21 CFR§882.5890,Transcutaneous electricalnerve stimulator for painrelief | No difference. Proposeddevice and predicate devicehave the same medical deviceclassification number. |
| Classification-Product Code | Primary: NUH -Transcutaneous electricalnerve stimulator for painrelief. Secondary: NYN-Transcutaneous electricalnerve stimulator for painrelief. | Primary: NUH -Transcutaneous electricalnerve stimulator for painrelief. Secondary: NYN-Transcutaneous electricalnerve stimulator for painrelief. | NUH - Transcutaneouselectrical nerve stimulatorfor pain relief | NUH - Transcutaneouselectrical nerve stimulator forpain relief | No difference. Proposeddevice and predicate devicehave the same medical deviceproduct code. |
| Indications for Use | The Focus TENS isintended for the relief ofpain associated with soreor aching muscles of thelower extremities (leg) dueto strain from exercise ornormal household workactivities.It is also intended for theuse of symptomatic reliefand management ofchronic, intractable painassociated with arthritis. | The Avail Wireless DualChannel TENS is intendedfor the relief of painassociated with sore oraching muscles of the lowerback, arms, legs, shoulders orfeet due to strain fromexercise or normal householdwork activities.When used for thesymptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis,choose Tap, Shoulder, Armor Leg mode. | Quell is intended for use asa transcutaneous electricalnerve stimulation device fortemporary relief of painassociated with sore andaching muscles in the lowerextremities due to strainfrom exercise or normalhousehold and workactivities.Quell is intended for use asa transcutaneous electricalnerve stimulation device forthe symptomatic relief andmanagement of chronicintractable pain.The device may be usedduring sleep. The device islabeled for use only with | This device is designed to beused for temporary relief ofpain associated with sore andaching muscles in theshoulder, waist, back, neck,upper extremities (arm), andlower extremities (leg) due tostrain from exercise ornormal household workactivities. | Similar to Avail but withnarrower use for knee ratherthan the leg generally. |
| Environments of Use: | Clinics, hospital and homeenvironments | Clinics, hospital and homeenvironments | |||
| Patient Population: | Adult |
{9}------------------------------------------------
| 100 1 1000 | |
|---|---|
| the was an any and the the more------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| 1 |
| 111300 |
|---|
| 1-1rmatic11/2 10/2 10/20170 |
| IoAWA 40PR 2661Change than the coupleﺍ ﺍﮮ1tCPB |
| IC1Callery of Children1410.001BB |
| 001. 1. 1.e100CILIVA. |
| 11And Income of the later of the later of the later of the later of the later of the later of the later of the later of the later of the later of the later of the later of theI1I |
| tianAnd AddresswaSI281 |
| ni ki------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﺮ1 |
| 1S |
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079Patient Population: Adult | Reference DeviceQuellK152954compatible NeuroMetrixelectrodes. | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
|---|---|---|---|---|---|
| Environment of Use | Clinics, hospitals and homeenvironments | Clinics, hospitals and homeenvironments | Unknown | Unknown | Same as Avail |
| Patient Population | Adults | Adults | Adults | Adults | No difference. Intended forsame population. |
| Contraindications/Warnings/Precautions | ContraindicationsDo not use this device ifyou have a cardiacpacemaker, implanteddefibrillator, or otherimplanted metallic orelectronic device. Such usecould cause electric shock,burns, electricalinterference, or death. | ContraindicationsDo not use this device if youhave a cardiac pacemaker,implanted defibrillator, orother implanted metallic orelectronic device. Such usecould cause electric shock,burns, electrical interference,or death. | ContraindicationsDo not use this device if youhave a cardiac pacemaker,implanted defibrillator, orother implanted metallic orelectronic device. Such usecould cause electric shock,burns, electricalinterference, or death. | Contraindications1) Do not use this device ifyou have a cardiacpacemaker, implanteddefibrillator, or otherimplanted metallic orelectronic device. Such usecould cause electric shock,burns, electrical interference,or death.2) The device should not beused when cancerous lesionsor other lesions are present inthe treatment area.3) Stimulation should not beapplied over swollen,infected, inflamed areas orskin eruptions (e.g. phlebitis,thrombophlebitis, varicoseveins, etc.).4) Electrode placements mustbe avoided in the carotidsinus area (anterior neck) ortran-scerebrally (through thehead).5) This device should not beused in overly enervated | Same as Avail and Quell forContraindications |
| Table 1: Substantial Equivalence Table – Regulatory Information (cont.) | |||||
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601,K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
| areas.6) Inguinal hernia.7) Do not use on scarredareas following a surgery forat least 10 months after theoperation.8) Do not use with seriousarterial circulatory problemsin the lower limbs. | |||||
| Single Use | Pads are for single patient use | Pads are for single patient use | Pads are for single patient use | Pads are for single patient use | No difference. Proposed andpredicate devices are durablemedical equipment intendedfor multiple uses. |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | Unknown | Unknown | No difference. Proposed andpredicate device are providednonsterile. |
| Specifications/FeaturesOver-the-Counter(OTC) | Yes | Yes | Yes | Yes | No difference |
| Power Source(s) | Rechargeable Lithium-ionbattery | Rechargeable Lithium-ionbattery | Rechargeable Lithium-ionbattery | 6.0 V D.C., 4 x AAAbatteries | Same battery type as Availand QuellNo difference |
| Method of LineCurrent Isolation | N/A (internal powersource) | N/A (internal power source) | N/A (internal power source) | N/A (internal power source) | |
| Patient LeakageCurrent | --- | --- | --- | --- | --- |
{10}------------------------------------------------
{11}------------------------------------------------
| has a le have " starts and the in an | |
|---|---|
| 1 | |
|---|---|
| O VAVAA O AUV OARA CA WARREN WARREN WARREN BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE1 | |
| WAWA 40Party of the Br------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 | |
| C111 | |
| A A WANo. of Conce | |
| when at need sound second coups and subscription of the contraction of the contribution and subject of the county of the county of the county of the county of the county of t | |
| of Children of Concession | |
| And W | |
| Carolina Continued Concession Company of Concession,1NAI A | |
| State Production Come of Concession Comers of Concessional Construction of Construction of Construction of Construction of Children1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------2 | |
| 114 |
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
|---|---|---|---|---|---|
| -Normal Condition(uA) | <10uA | <10uA | <10uA | 11.4uA | Same as Avail |
| -Single FaultCondition (uA) | <50uA | <50uA | <100uA | 9.6uA | Same as Avail |
| Average DC currentthrough electrodeswhen device is onbut no pulse arebeing applied (uA) | 0 | 0 | <1uA | 0 | No difference |
| Number of outputModes | 1 TENS mode | 9 TENS modes | 1 TENS mode | 18 TENS modes | Same as Quell |
| Number of outputchannels | 1ch | 1ch | 1ch | Alternating 2 channels | Same as Avail and Quell |
| Synchronous orAlternating | None | None | N/A | By electrical circuit andsoftware | Same as Avail |
| Method of ChannelIsolation | Regulated Current | Regulated Current | Regulated current | Regulated current | No difference |
| Regulated Currentor RegulatedVoltage | Microprocessor | Microprocessor | Yes | Yes | No difference |
| Software/Firmware/MicroprocessorControl? | No | No | Yes | Yes | Same as Avail |
| Automatic OverloadTrip? | Yes | Yes | Yes | Yes | No difference |
| Automatic No-LoadTrip? | Yes | Yes | Yes | Yes | No difference |
| Automatic shut Off? | Yes, Power On/Off buttonon the device | Yes, Power On/Off button onthe device and in the Appsoftware | 4 button presses | Yes | Similar to Avail but with noApp associated with FocusTENS |
| User over ridecontrol? |
A5-10
{12}------------------------------------------------
| 1C1 | 1 | |
|---|---|---|
| 1 | ||
| C | ||
| € | WA TO WARDS OF THE | AAA V & AAA TVAV |
| ------------------------------------------------------------------------------------------------------------------------ | ||
| And Annual Property of Children | ||
| -€ | ||
| 1 | ||
| 1 | 1€ | |
| Caroline | 1 | |
| No. of Conce | ||
| when a need cours nown some and submit | 1 | |
| 1 | ||
| 400 W | The Real Property of Children | |
| wa | ||
| WALL CALLERY | ||
| 1 | Call of Children | |
| 1 | 2 | |
| 1 | ||
| C | Caroline of Children |
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
|---|---|---|---|---|---|
| Indication displayOn/Off Status? | Yes. LED indicator onmain unit | Yes on App and LEDindicator on main unit | Yes | Yes | Similar to Avail but with noApp associated with FocusTENS |
| Low Battery? | Yes. LED indicator onmain unit | Yes on App | Yes | Yes | Similar to Avail but with noApp associated with FocusTENS |
| Voltage/CurrentLevel? | Yes. LED indicator onmain unit | Yes on App | No | Yes | Similar to Avail but with noApp associated with FocusTENS |
| Timer Range(Minutes) | 30 minutes | 5-60minutes and30-180minutes | 60 minutes | 30 minutes | Same as R-T1 and withinrange of Avail |
| Compliance withVoluntarystandards? | ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | ES 60601-1, IEC60601-1-2,IEC60601-2-10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC62304, IEC 60601-1-11 | IEC 60601-1, IEC60601-1-2,IEC60601-2-10, IEC 60601-1-11 | Same as Avail |
| Compliance with 21CFR898? | N/A (no patient cable) | N/A (no patient cable) | Yes | Yes | Same as Avail |
| Weight | Device: Approx. 1.9 oz (55g)Knee pad: Approx. 0.7 oz(20 g)Knee band M: Approx. 1.0oz (27 g)Knee band L: Approx. 1.0oz (29 g)Charger: Approx. 3.5 oz(100 g) | Device: Approx. 42 g (Bothunits have same weight)Pad-L: Approx. 25 gPad-M: Approx. 20 gCharger: Approx. 100 g | 62g (2.2 oz) | 0.243 (lbs., oz.) | Similar. Difference does notaffect safety and effectivenessof use. |
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSStimulatorK180956 | Analysis of TechnologicalDifferences |
| Dimensions (W x Hx D) | Device: Approx. 2.3 (W) ×2.8" (H) x 0.6" (D) (60 ×72 × 16 mm)Charger: Approx. 3.5" (W)× 3.1" (H) x 0.9" (D) (90x 80 x 23.5 mm)Knee pad: Approx. 5.1"(W) x 2.3" (H) x 0.6" (D)(130×60×16 mm)Knee Band M: Approx.15.1" (W) x 2.5" (H) (385× 64 mm)Knee Band L: Approx.17.7" (W) x 2.5" (H) (450× 64 mm) | Device: Approx. 60 (W)× 72(H)x 15.5 (D)mm(Both units have sameweight)Charger: Approx. 158 (W)x90 (H)x 20.5 (D)mmPad-L: Approx. 219 (W) ×83.5 (H) × 7.5 (D)mmPad-M: Approx. 180 (W) ×79.5 (H) × 7.5 (D)mm | 11mm (0.4") x 74mm (2.9")x 98mm (3.9") | 4.82x2.78x1.08 (in.) | Similar. Difference does notaffect safety and effectivenessof use. |
| Operatingconditions | 10 to 40 °C30 to 80%RH700 to 1060 hPa (non-condensing) | 10 to 40 °C30 to 80%RH700 to 1060 hPa (non-condensing) | -5° C to 40° C15% to 93%70 kPa to 106 kPa | 5°C | Same as Avail |
| Charging conditions | 5 to 35 °C (non-condensing) | 5 to 35 °C (non-condensing) | -5° C to 40° C15% to 93%70 kPa to 106 kPa | N/A(no rechargeable battery) | Same as Avail |
| Storage conditions | 0 to 40 °C30 to 80% RH (non-condensing) | 0 to 40 °C30 to 80% RH (non-condensing) | -25° C to 70° C10% to 93%70 kPa to 106 kPa | -10°C | Same as Avail |
| Transportingconditions | -20 to 60 °C10 to 90% RH (non-condensing) | -20 to 60 °C10 to 90% RH (non-condensing) | -25° C to 70° C10% to 93%70 kPa to 106 kPa | -10°C | Same as Avail |
| Electrode style | HV-KNPAD-ZReusable | HV-WPAD-M or HV-WPAD-LReusable | Quell electrodesReusable | Reusable | Similar to Avail and Quell |
| Feature | Proposed DevicePM710-M/PM710-L | Primary Predicate DeviceOmron Avail Wireless DualChannel TENS PM601K172079 | Reference DeviceQuellK152954 | Reference DeviceModel R-T1 TENSSimulatorK180956 | Analysis of TechnologicalDifferences |
| Patient ContactAccessory | Yes | Yes | Yes | Yes | No difference |
{13}------------------------------------------------
(Cont.)
Regulatory Information
Substantially Equivalent
A5-12
{14}------------------------------------------------
0(k) SUMMARY (CONT.
Table 1: Substantial Equivalence Table – Regulatory Information (cont.
{15}------------------------------------------------
| 1 | |
|---|---|
| A W A 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | |
| 11000 V 1 |
| PM7 | ||
|---|---|---|
| or | ||
| 0 | I | |
| n | ||
| ariso | ||
| omp: | ||
| C | ||
| U | ||
| up | ||
| U | ||
| C | S | |
| . . | ||
| ( | ||
| ರ | ||
| bl |
| Parameter | Mode of Program Name | Knee | Steady | Acupuncture Like | Knead | Tap | Lower Back | Shoulder | Joint | Leg | Arm | Microcurrent | Standard | Alternative |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Focus TENSPM710-M/-L | Avail K172079 | Quell K152954 | ||||||||||||
| Waveform | 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 | |
| MaximumOutputVoltage [V] | @500Ω | 45.0 | 25.9 | 38.4 | 27.9 | 38.3 | 38.2 | 38.4 | 25.6 | 36.7 | 38.2 | 0.0 | 49.2 | 49.4 |
| @2kΩ | 68.6 | 45.2 | 50.8 | 37.2 | 50.3 | 50.4 | 50.4 | 35.7 | 49.5 | 50.4 | 0.1 | |||
| @10kΩ | 78.5 | 59.9 | 55.2 | 40.7 | 54.9 | 55.8 | 55.8 | 39.2 | 54.6 | 55.2 | 0.5 | |||
| MaximumOutputCurrent [mA] | @500Ω | 90.0 | 51.8 | 76.8 | 55.8 | 76.6 | 76.4 | 76.8 | 51.2 | 73.4 | 76.4 | 0.1 | 98.4 | 98.8 |
| @2kΩ | 34.3 | 22.6 | 25.4 | 18.6 | 25.2 | 25.2 | 25.2 | 17.9 | 24.8 | 25.2 | 0.1 | |||
| @10kΩ | 7.9 | 6.0 | 5.5 | 4.1 | 5.5 | 5.6 | 5.6 | 3.9 | 5.5 | 5.5 | 0.1 | |||
| Duration of primary phase[µsec] | 60 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 2500000 | 100 | 100 | |
| Pulse Duration [µsec] | 60 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 2500000 | 100 | 100 | |
| Frequency [Hz] | 1-250 | 99 | 2 | 51.65 | 1-20.13 | 2-108 | 1-19 | 42.43-108 | 2-51.65 | 2-51.65 | 0.2 | 60-100 | 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 |
| 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 | |
| Net Charge(µC per pulse)(@500Ω) [uC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
{16}------------------------------------------------
| Villa | |
|---|---|
| A Was a last " and the last to the- | |
| 1( |
| € | ﮯ | ||
|---|---|---|---|
| - | |||
| œ | |||
| I | |||
| 1 | |||
| PM7 | 1 | ||
| 1 | |||
| 114 | 1 | ||
| 0 | |||
| 1 | |||
| ISON | |||
| rist | |||
| mpar | |||
| C | 1 | ||
| A | |||
| tput | |||
| u | |||
| 11 10 | |||
| ( | J | ||
| ble | |||
| - | |||
| - |
| 5.40 | 4.97 | 7.37 | 5.36 | 7.35 | 7.33 | 7.37 | 4.92 | 7.05 | 7.33 | 125.00 | 9.84 | 9.88 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.97 | 0.16 | 0.03 | 0.09 | 0.11 | 0.17 | 0.10 | 0.12 | 0.12 | 0.12 | 0.00 | 0.50 | 0.45 | |
| 2.70 | 0.98 | 0.03 | 0.28 | 0.30 | 0.79 | 0.28 | 0.53 | 0.36 | 0.38 | 0.03 | 1.97 | 1.58 | |
| 7.59E-03 | 5.71E-04 | 2.53E-05 | 1.73E-04 | 2.54E-04 | 6.77E-04 | 2.41E-04 | 3.04E-04 | 2.99E-04 | 3.24E-04 | 1.40E-08 | 3.46E-03 | 2.79E-03 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 4.0 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 2.1 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 0.1 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 0.2 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 0.1 | |
| N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | 0.4 | |
| 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 |
{17}------------------------------------------------
| #11 |
|---|
| 21( |
| TEN!1711 |
| 4E1l |
| 1l |
| Inr1 0 10 |
| omparison |
| N) |
| tputह1 |
| t1 |
| € |
| able 3:WP |
| Parameter | R-T1 TENS Stimulator K180956 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | Shoulder(P1) | Shoulder(P2) | Shoulder(P3) | Back(P1) | Back(P2) | Back(P3) | Arm(P1) | Arm(P2) | Arm(P3) | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage [V] | @500Ω29.4 | @500Ω29.6 | @500Ω29.0 | @500Ω30.0 | @500Ω29.2 | @500Ω28.8 | @500Ω29.2 | @500Ω28.4 | @500Ω29.4 | |
| @2ΚΩ104.5 | @2ΚΩ108.0 | @2ΚΩ109.0 | @2ΚΩ111.5 | @2ΚΩ107.0 | @2ΚΩ111.5 | @2ΚΩ106.5 | @2ΚΩ109.5 | @2ΚΩ111.5 | ||
| @10ΚΩ111.5 | @10ΚΩ113.0 | @10ΚΩ112.5 | @10ΚΩ114.5 | @10ΚΩ112.0 | @10ΚΩ115.5 | @10ΚΩ108.0 | @10ΚΩ113.0 | @10ΚΩ115 | ||
| Maximum Output Current [mA] | @500Ω58.8 | @500Ω59.2 | @500Ω58.0 | @500Ω60.0 | @500Ω58.4 | @500Ω57.6 | @500Ω58.4 | @500Ω56.8 | @500Ω58.8 | |
| @2ΚΩ52.3 | @2ΚΩ54.0 | @2ΚΩ54.5 | @2ΚΩ55.8 | @2ΚΩ53.5 | @2ΚΩ55.8 | @2ΚΩ53.3 | @2ΚΩ54.8 | @2ΚΩ55.75 | ||
| @10ΚΩ11.2 | @10ΚΩ11.3 | @10ΚΩ11.3 | @10ΚΩ11.5 | @10ΚΩ11.2 | @10ΚΩ11.6 | @10ΚΩ10.8 | @10ΚΩ11.3 | @10ΚΩ11.5 | ||
| Duration of primary phase [usec] | 250 | 253 | 205 | 256 | 253 | 332 | 252.4 | 197 | 201 | |
| Pulse Duration [usec] | 250 | 253 | 205 | 256 | 253 | 332 | 252.4 | 197 | 201 | |
| Frequency [Hz] | 2-6 | 4-8 | 2-125 | 10-80 | 6-10 | 100 | 2 | 2-100 | 100 | |
| For multiphasic waveforms only: | Symmetrical phases | 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 | |
| Net Charge(µC per pulse) (@500Ω) [uC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Maximum Phase Charge (@500Ω) [μC] | 14.70 | 14.98 | 11.89 | 15.36 | 14.78 | 19.12 | 14.74 | 11.19 | 11.82 |
{18}------------------------------------------------
| Andrew of the propertyWAe) |
|---|
| ----------Propertymanufa- |
| COLLATO21111 |
| 1TT 11I0 |
| 61111 11. 11.41110 |
| o manage and min of anyบ ทาง ที่ 1 ในปี ค.ศ. 141 ปี ด ท |
| AC |
| 11------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 |
| C11€ |
| 1Cœ1160 K11P21œ1 |
| Parameter | R-T1 TENS StimulatorK180956 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Maximum Current Density (@500Ω)[mA/cm2] r.m.s. | 0.20 | 0.24 | 0.82 | 0.76 | 0.26 | 0.93 | 0.12 | 0.70 | 0.74 | |
| Maximum Average Current (averageabsolute value), mA | 0.18 | 0.24 | 2.97 | 2.46 | 0.30 | 3.82 | 0.06 | 2.24 | 2.36 | |
| Maximum Average Power Density(@500Ω) [W/cm²] | 3.24E-04 | 4.43E-04 | 5.39E-03 | 4.61E-03 | 5.39E-04 | 6.88E-03 | 1.08E-04 | 3.97E-03 | 4.34E-03 | |
| Burst Mode | (a) Pulses perburst | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| (b) Bursts persecond | 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 | |
| (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 | |
| ON Time (seconds) | 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 | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
{19}------------------------------------------------
| Parameter | R-T1 TENS Stimulator K180956 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | Hip(P1) | Hip(P2) | Hip(P3) | Leg(P1) | Leg(P2) | Leg(P3) | Joint(P1) | Joint(P2) | Joint(P3) | Knead | Rub | Tap | |
| Waveform | 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 | |
| MaximumOutputVoltage[V] | @500Ω | 29.2 | 29.4 | 29 | 29.6 | 29.4 | 28.6 | 29.6 | 29.6 | 29.6 | 30 | 29.6 | 30 |
| @2kΩ | 111.5 | 112.5 | 112.5 | 112.5 | 111 | 108 | 111 | 109.5 | 112 | 106 | 109.5 | 111.5 | |
| @10kΩ | 114 | 115.5 | 112.5 | 114 | 113 | 112.5 | 112.5 | 115.5 | 114 | 114 | 114 | 116.5 | |
| MaximumOutputCurrent[mA] | @500Ω | 58.4 | 58.8 | 58 | 59.2 | 58.8 | 57.2 | 59.2 | 59.2 | 59.2 | 60 | 59.2 | 60 |
| @2kΩ | 55.75 | 56.25 | 56.25 | 56.25 | 55.5 | 54 | 55.5 | 54.75 | 56 | 53 | 54.75 | 55.75 | |
| @10kΩ | 11.4 | 11.55 | 11.25 | 11.4 | 11.3 | 11.25 | 11.25 | 11.55 | 11.4 | 11.4 | 11.4 | 11.65 | |
| Duration of primary phase [usec] | 152.8 | 255 | 203.5 | 250.7 | 155 | 253 | 201.4 | 156.9 | 155.2 | 220 | 219 | 225.5 | |
| Pulse Duration [usec] | 152.8 | 255 | 203.5 | 250.7 | 155 | 253 | 201.4 | 156.9 | 155.2 | 220 | 219 | 225.5 | |
| Frequency [Hz] | 100 | 6-50 | 100 | 4-50 | 100 | 6-10 | 2-100 | 100 | 80 | 83-132 | 25-79 | 147-291 | |
| 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 |
| 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 | |
| Net Charge(µC per pulse) (@500Ω) [µC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Parameter | R-T1 TENS StimulatorK180956 | ||||||||||||
| Maximum Phase Charge(@500Ω) [μC] | 8.92 | 14.99 | 11.80 | 14.84 | 9.11 | 14.47 | 11.92 | 9.29 | 9.19 | 13.20 | 12.96 | 13.53 | |
| Maximum Current Density(@500Ω) [mA/cm2] r.m.s. | 0.64 | 0.59 | 0.73 | 0.59 | 0.65 | 0.25 | 0.74 | 0.66 | 0.58 | 0.90 | 0.69 | 1.36 | |
| Maximum Average Currentaverage absolute value), mA | 1.78 | 1.50 | 2.36 | 1.48 | 1.82 | 0.29 | 2.38 | 1.86 | 1.47 | 3.48 | 2.05 | 7.87 | |
| Maximum Average PowerDensity (@500Ω) [W/cm²] | 3.26E-03 | 2.76E-03 | 4.28E-03 | 2.75E-03 | 3.35E-03 | 5.17E-04 | 4.41E-03 | 3.44E-03 | 2.72E-03 | 6.53E-03 | 3.79E-03 | 1.48E-02 | |
| BurstMode | (a) Pulses perburst | N/A | N/A | 25 | N/A | 25 | N/A | N/A | 25 | N/A | N/A | N/A | N/A |
| (b) Bursts persecond | N/A | N/A | 2.00 | N/A | 2.06 | N/A | N/A | 2.00 | N/A | N/A | N/A | N/A | |
| (c) Burstduration | N/A | N/A | 0.24 | N/A | 0.24 | N/A | N/A | 0.24 | N/A | N/A | N/A | N/A | |
| (d) Duty cycle:Line(b)xLine(c) | N/A | N/A | 0.48 | N/A | 0.49 | N/A | N/A | 0.48 | N/A | N/A | N/A | N/A | |
| ON Time (seconds) | N/A | N/A | 0.24 | N/A | 0.24 | N/A | N/A | 0.241 | N/A | N/A | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | 0.26 | N/A | 0.245 | N/A | N/A | 0.258 | 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 |
arison for R-T1 TENS #2 out Comps Tabla 1. Qui
{20}------------------------------------------------
§ 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).