(101 days)
No
The device description and performance studies do not mention any AI or ML components. The control is described as being through a dedicated app, but there is no indication that this app utilizes AI/ML for therapy modes or control.
Yes
The device is intended for the relief of pain associated with sore or aching muscles and for the symptomatic relief and management of chronic, intractable pain, which are therapeutic uses. It delivers TENS technology and microcurrent therapy, both of which are therapeutic modalities.
No
Explanation: The device is described as an electrotherapy device intended for pain relief through TENS and microcurrent therapy, not for diagnosing conditions.
No
The device description clearly states it includes physical components such as TENS units, gel pads, a charger, and a storage case, in addition to the software application.
Based on the provided text, the Avail device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the relief of pain associated with sore or aching muscles and for the symptomatic relief and management of chronic, intractable pain and pain associated with arthritis. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a wearable electrotherapy device that delivers TENS and microcurrent therapy. These are physical therapies applied to the body, not tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, the Avail device falls under the category of a therapeutic medical device, specifically an electrotherapy device for pain relief.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
NUH, NYN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, arms, legs, shoulders or feet
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
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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3
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
4
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
5
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).
6
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
7
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.
8
Table 1. Substantial Equivalence Summary
| Feature | Proposed Device
Omron Avail
Wireless Dual
Channel TENS
PM601 | Primary Predicate
Device
Philips PulseRelief
(K151035) | For TENS Function | | For Microcurrent | 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 | 21 CFR§882.5890,
Transcutaneous
electrical nerve
stimulator for pain
relief | No difference. Proposed
device and predicate
devices 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: NGX -
Stimulator, Muscle,
Powered, For Muscle
Conditioning | 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
devices have the
same medical device
product code. | |
| Indications for Use | 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 | The OTC
TENS/EMS
stimulator
PulseRelief 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 | To be used for
temporary relief of
pain associated
with sore and
aching muscles due
to strain from
exercise or normal
household and
work activities.
To be used for
symptomatic relief
and management of
chronic, intractable
pain and relief of
pain associated | The Omron Heat Pain
Pro is intended for:
The relief of pain
associated with sore
or aching, muscles of
the lower back, arms,
legs, shoulder, or foot
due to strain from
exercise or normal
household work
activities.
Environments of Use:
Clinics, hospital and
home environments
Patient Population: | The Painmaster
MCT Patch is
indicated for
temporary relief of
pain associated
with sore and
aching muscles in
upper and lower
extremities (arm
and/or leg) due to
strain from exercise
or normal
household and
work activities. | Similar to PulseRelief and
Heat Pain Pro for
temporary relief of pain
with sore and aching
muscles. Similar to
SmartRelief with respect to
symptomatic relief and
management of chronic,
intractable pain, and relief
of pain associated with
arthritis. | |
| Feature | Proposed Device
Omron Avail
Wireless Dual
Channel TENS
PM601 | For TENS Function | | For Microcurrent | Analysis of Technological
Differences | | |
| | | Primary Predicate
Device
Philips PulseRelief
(K151035) | Reference Device
SmartRelief
(K131159) | Reference Device
Omron Heat Pain
Pro (K160115) | Reference Device
Painmaster MCT
Patch (K130114) | | |
| | arthritis, choose Tap,
Shoulder, Arm or Leg
mode.
Environments of Use:
Clinics, hospital and
home environments
Patient Population:
Adult | normal household
work activities.
It should be applied
to normal, healthy,
dry and clean skin of
adult patients, and is
to be used to
stimulate healthy
muscles in order to
improve and facilitate
muscle performance. | with arthritis. | Adult | | | |
| Environment of Use | Clinics, hospitals and
home environments | Home | Unknown | Clinics, hospital and
home environments | Home | Same as Heat Pain Pro,
SmartRelief and
Painmaster | |
| Patient Population | Adults | Adults | Adults | Adults | Over 12 years of
age, unless under
physician
supervision | Predicate device intended
for same population.
Painmaster indicated for
over 12 years of age, unless
physician supervised. | |
| Feature | Proposed Device
Omron Avail
Wireless Dual
Channel TENS
PM601 | For TENS Function | | | For Microcurrent | Analysis of Technological
Differences | |
| | | Primary Predicate
Device
Philips PulseRelief
(K151035) | Reference Device
SmartRelief
(K131159) | Reference Device
Omron Heat Pain
Pro (K160115) | Reference Device
Painmaster MCT
Patch (K130114) | | |
| 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 with the
following medical
devices:
-- Implanted
electronic medical
devices, such as
pacemakers.
This may cause
electric shock, burns,
or death.
-- Electronic life
support equipment,
such as respirators.
-- Electronic medical
devices worn on the
body, such
as
electrocardiographs.
If you use this device
together with other
electronic
medical devices,
these devices may not
work correctly. | 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 with
pacemakers or
anyone using
transdermal drug
delivery
Do not place
patches along neck
Do not place
patches in a way
that causes flow of
current through
head | Contraindications are
similar for all devices. | |
| Feature | Proposed Device
Omron Avail
Wireless Dual
Channel TENS
PM601 | | For TENS Function | For Microcurrent | Analysis of Technological
Differences | | |
| | Primary Predicate
Device
Philips PulseRelief
(K151035) | Reference Device
SmartRelief
(K131159) | Reference Device
Omron Heat Pain
Pro (K160115) | Reference Device
Painmaster MCT
Patch (K130114) | | | |
| Single Use | Patient-contacting
Pads are for single
patient use | Patient-contacting
electrodes are for
single patient use | Unknown | Pads are for single
patient use | Pads should only
be used by one
person | No difference. Proposed
and predicate TENS
devices are durable
medical equipment
intended for multiple uses.
Patient-contacting
components are for use by
a single adult patient. | |
| Sterility | External contacting
device, nonsterile | Unknown | Unknown | External contacting
device, nonsterile | Unknown | No difference. Proposed
and predicate device are
provided
nonsterile. | |
| Specification/Features | | | | | | | |
| Over-the-Counter
(OTC) | Yes | Yes | Yes | Yes | Yes | No difference | |
| Power Source(s) | Rechargeable Lithium-
ion battery | Rechargeable
Lithium-ion battery | 3V CR2032
lithium battery | Rechargeable
Lithium-ion battery | Primary battery
only. One-time use. | Same battery type as Heat
Pain Pro and PulseRelief | |
| Method of Line
Current Isolation | N/A (internal power
source) | N/A | N/A | N/A (internal power
source) | N/A | No difference | |
| Patient Leakage
Current: | --- | --- | --- | --- | --- | --- | |
| -Normal Condition
(uA) | $