(292 days)
NYN, NUH
No
The device description and performance studies focus on standard electrotherapy (TENS) technology and its electrical and mechanical properties. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes.
The device's intended use is for the relief and management of pain associated with sore muscles and arthritis, which are therapeutic applications.
No
The device is described as a wearable electrotherapy device intended for pain relief through Transcutaneous Electrical Nerve Stimulation (TENS), not for diagnosing conditions. Its intended use focuses on managing symptoms (pain relief) rather than identifying or characterizing a disease or condition.
No
The device description explicitly states it is a "wearable electrotherapy device" and includes physical components like a "main TENS unit," "reusable, self-adhesive contouring pads," a "gel and a medium or large band," a "charger," an "AC adapter," and a "pad holder and storage case." The performance studies also detail bench testing on hardware characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of pain associated with sore or aching muscles and chronic, intractable pain associated with arthritis. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a wearable electrotherapy device that delivers TENS (Transcutaneous Electrical Nerve Stimulation). TENS is a therapeutic modality, not a diagnostic one.
- Mechanism of Action: TENS works by stimulating nerves to block pain signals or release endorphins. This is a physical intervention, not a test performed on a biological sample.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not involve the analysis of any biological samples.
Therefore, the PM710 is a therapeutic device, specifically a TENS unit, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NUH, NYN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities (leg)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinics, hospital and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary bench and nonclinical testing were conducted on the PM710 to support a determination of substantial equivalence to the predicate device. 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 (Current Consumption, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omron Avail Wireless Dual Channel TENS PM601 (K172079)
Reference Device(s)
Neurometrix, Inc. Quell (K152954), Shenzhen Roundwhale Technology Co., Ltd Model R-T1 TENS stimulator (K180956)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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
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| Feature | Proposed Device
Focus TENS
PM710-M/PM710-L | Primary Predicate Device
Omron Avail Wireless Dual
Channel TENS PM601
K172079 | Reference Device
Quell
K152954 | Reference Device
Model R-T1 TENS
Stimulator
K180956 | Analysis of Technological
Differences |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Classification-
Regulation | 21 CFR§882.5890,
Transcutaneous electrical
nerve stimulator for pain
relief | 21 CFR§882.5890,
Transcutaneous electrical
nerve stimulator for pain
relief | 21 CFR§882.5890,
Transcutaneous electrical
nerve stimulator for pain
relief | 21 CFR§882.5890,
Transcutaneous electrical
nerve stimulator for pain
relief | No difference. Proposed
device and predicate device
have the same medical device
classification number. |
| Classification-
Product Code | Primary: NUH -
Transcutaneous electrical
nerve stimulator for pain
relief. Secondary: NYN-
Transcutaneous electrical
nerve stimulator for pain
relief. | Primary: NUH -
Transcutaneous electrical
nerve stimulator for pain
relief. Secondary: NYN-
Transcutaneous electrical
nerve stimulator for pain
relief. | NUH - Transcutaneous
electrical nerve stimulator
for pain relief | NUH - Transcutaneous
electrical nerve stimulator for
pain relief | No difference. Proposed
device and predicate device
have the same medical device
product code. |
| Indications for Use | The Focus TENS 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. | The Avail Wireless Dual
Channel TENS 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,
choose Tap, Shoulder, Arm
or Leg mode. | Quell is intended for use as
a transcutaneous electrical
nerve stimulation device for
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.
Quell is intended for use as
a transcutaneous electrical
nerve stimulation device for
the symptomatic relief and
management of chronic
intractable pain.
The device may be used
during sleep. The device is
labeled for use only with | This device is designed to be
used for temporary relief of
pain associated with sore and
aching muscles in the
shoulder, waist, back, neck,
upper extremities (arm), and
lower extremities (leg) due to
strain from exercise or
normal household work
activities. | Similar to Avail but with
narrower use for knee rather
than the leg generally. |
| Environments of Use: | Clinics, hospital and home
environments | Clinics, hospital and home
environments | | | |
| Patient Population: | Adult | | | | |
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| Feature | Proposed Device
PM710-M/PM710-L | Primary Predicate Device
Omron Avail Wireless Dual
Channel TENS PM601
K172079
Patient Population: Adult | Reference Device
Quell
K152954
compatible NeuroMetrix
electrodes. | Reference Device
Model R-T1 TENS
Stimulator
K180956 | Analysis of Technological
Differences |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Environment of Use | Clinics, hospitals and home
environments | Clinics, hospitals and home
environments | Unknown | Unknown | Same as Avail |
| Patient Population | Adults | Adults | Adults | Adults | No difference. Intended for
same population. |
| Contraindications/Warnings/Precautions | Contraindications
Do not use this device if
you have a cardiac
pacemaker, implanted
defibrillator, or other
implanted metallic or
electronic device. Such use
could cause electric shock,
burns, electrical
interference, or death. | Contraindications
Do not use this device if you
have a cardiac pacemaker,
implanted defibrillator, or
other implanted metallic or
electronic device. Such use
could cause electric shock,
burns, electrical interference,
or death. | Contraindications
Do not use this device if you
have a cardiac pacemaker,
implanted defibrillator, or
other implanted metallic or
electronic device. Such use
could cause electric shock,
burns, electrical
interference, or death. | Contraindications
- Do not use this device if
you have a cardiac
pacemaker, implanted
defibrillator, or other
implanted metallic or
electronic device. Such use
could cause electric shock,
burns, electrical interference,
or death. - The device should not be
used when cancerous lesions
or other lesions are present in
the treatment area. - Stimulation should not be
applied over swollen,
infected, inflamed areas or
skin eruptions (e.g. phlebitis,
thrombophlebitis, varicose
veins, etc.). - Electrode placements must
be avoided in the carotid
sinus area (anterior neck) or
tran-scerebrally (through the
head). - This device should not be
used in overly enervated | Same as Avail and Quell for
Contraindications |
| | Table 1: Substantial Equivalence Table – Regulatory Information (cont.) | | | | |
| Feature | Proposed Device
PM710-M/PM710-L | Primary Predicate Device
Omron Avail Wireless Dual
Channel TENS PM601,
K172079 | Reference Device
Quell
K152954 | Reference Device
Model R-T1 TENS
Stimulator
K180956 | Analysis of Technological
Differences |
| | | | | areas. - Inguinal hernia.
- Do not use on scarred
areas following a surgery for
at least 10 months after the
operation. - Do not use with serious
arterial circulatory problems
in 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 and
predicate devices are durable
medical equipment intended
for multiple uses. |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | Unknown | Unknown | No difference. Proposed and
predicate device are provided
nonsterile. |
| Specifications/
Features
Over-the-Counter
(OTC) | Yes | Yes | Yes | Yes | No difference |
| Power Source(s) | Rechargeable Lithium-ion
battery | Rechargeable Lithium-ion
battery | Rechargeable Lithium-ion
battery | 6.0 V D.C., 4 x AAA
batteries | Same battery type as Avail
and Quell
No difference |
| Method of Line
Current Isolation | N/A (internal power
source) | N/A (internal power source) | N/A (internal power source) | N/A (internal power source) | |
| Patient Leakage
Current | --- | --- | --- | --- | --- |
10
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14 | |
| Feature | Proposed Device
PM710-M/PM710-L | Primary Predicate Device
Omron Avail Wireless Dual
Channel TENS PM601
K172079 | Reference Device
Quell
K152954 | Reference Device
Model R-T1 TENS
Stimulator
K180956 | Analysis of Technological
Differences |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------|
| -Normal Condition
(uA) |