(135 days)
This device 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 and work activities.
The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10. The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics. The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.
The provided text is a 510(k) summary for the Omron Maxpower relief (PM3032), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. It describes the device and compares it to predicate devices to establish substantial equivalence, rather than detailing a specific study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not directly present as it would be for a clinical trial demonstrating the efficacy or performance of a new device against predefined metrics.
However, based on the provided document, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document establishes "substantial equivalence" as the primary acceptance criterion, specifically, that the Maxpower relief (PM3032) is substantially equivalent to predicate devices (K110068 - Omron PM3030 and K121757 - Healthmate International Pro-8AB).
| Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Maxpower relief (PM3032) vs. Predicates) |
|---|---|
| Indications for Use: 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 and work activities. | Substantially equivalent / Virtually identical to both predicate devices (PM3030: lower back, arms, or legs; Pro-8AB: shoulder, waist, back, neck, upper/lower extremities). |
| Prescriptive Status: Over-The-Counter Use (OTC) | Identical (all devices are OTC). |
| Design and Technology: Equivalent design and features, identical technology to PM3030. | Equivalent design and features when compared to predicates; identical technology to PM3030. |
| Performance and Specifications: Equivalent specifications of performance. | Equivalent specifications of performance when compared to the predicates (Tables 5.1, 5.2, and Output Specifications show detailed electrical parameter comparisons). |
| Compliance with Standards: AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10. | Complies with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Predicates comply with similar, though sometimes older, versions of these standards. |
| Patient Contacting Materials (Biocompatibility): Long Life Pads must be compatible. | Long Life Pads data presented in K120516 (Irritation, delayed-type hypersensitivity, Cytotoxicity tests per ISO 10993-10 and ISO 10993-5). |
| Patient Population: Adults | Identical (adults). |
| Environment of Use: Clinics, hospital and home environments. | Identical to predicate K110068. |
| Non-Clinical Testing: Testing of all controls, indicators, battery state indicators, waveforms, and compliance with specified electrical and environmental standards (drop, vibration, temperature, humidity). | Performed and met requirements (specific results not detailed in this summary, but statement confirms testing was done). |
| Usability Testing: Performed. | Performed (results not detailed). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) summary, as it describes a substantial equivalence submission based on non-clinical engineering and performance comparisons, not a clinical study on a human "test set." The "test set" here refers to the device itself being tested for its electrical and physical characteristics against established engineering standards and comparison with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth, in the context of clinical expert consensus, is not relevant here as no clinical study with human data requiring expert interpretation was performed or referenced for performance. The "ground truth" for the non-clinical tests would be the specifications derived from the predicate devices and the requirements of the standards themselves, established by engineering and regulatory experts, but not individually enumerated here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No clinical adjudication process was described or required for this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a TENS unit, not an algorithm. Performance evaluation was based on its physical and electrical characteristics as a standalone medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established by:
- Engineering specifications of the predicate devices.
- Regulatory requirements and consensus standards (e.g., IEC 60601 series, ISO 10993 series), which represent a form of expert consensus in their development.
- Previous FDA clearances (510(k) numbers K110068 and K121757) for the predicate devices, which serve as a benchmark for what is already considered safe and effective.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the machine learning sense for this device. The device's design and manufacturing are based on established engineering principles and prior device models, not on a data-driven training process.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of a human figure, with the head, torso, and legs represented by curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAR 16 2015
Omron Healthcare, Inc. % Paul Dryden Consultant ProMedic. Inc. 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K141978
Trade/Device Name: Maxpower relief (PM3032) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 19, 2014 Received: October 21, 2014
Dear Mr. Dryden,
This letter corrects our substantially equivalent letter of December 3, 2014.
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.
{1}------------------------------------------------
Page 2 - Mr. Paul Dryden
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 (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.
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 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" (21CFR 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 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 yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Maxpower relief (PM3032) Indications for Use (Describe)
This device 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 and work activities.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
510(k) Summary Page 1 of 9 1/30/2015
| Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA | Tel - 847-247-5626Fax- 847-680-6269 |
|---|---|
| Official Contact: | Renee Thornborough - Director QA/RA |
| Proprietary or Trade Name: | PM3032 |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for painrelief. |
| Classification Name/Code: | NUH - stimulator, nerve, transcutaneous,over-the-counter21CFR 882.5890Class II |
| Device Name: | Maxpower relief |
| Predicate Devices: | K110068 - Omron - PM3030K121757 - Healthmate International - Pro8AB |
Device Description:
The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The specifications of each mode will be discussed in greater detail later in this section.
Software controls all controls and indicators. Software controls waveform characteristics.
This device is intended for the relief of pain associated with sore or aching, muscles of the shoulder, lower back, arms, or legs due to strain from exercise or normal household and work activities.
The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part.
As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.
{4}------------------------------------------------
510(k) Summary Page 2 of 9 1/30/2015
We have provided the information suggested in Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use from April 5, 2010. A checklist in accordance with this guidance can be found in Section 18 of this submission
Intended User OTC
Patient Population
Adults
Indications for Use:
This device 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 and work activities.
Environment of Use:
Clinics, hospital and home environments
Contraindications:
- Use with a pacemaker or other implanted metallic or electronic device. ●
- Use with a life-supporting medical electronic device such as an artificial heart or . lung or respirator
- Use in the presence of monitoring equipment (e.g. cardiac monitors, ECG alarms) ●
- Simultaneous connection of a patient to a high frequency surgical unit ●
- Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy . equipment
- . Use with another TENS device
Predicate Device Comparison:
The Maxpower relief (PM3032) was compared to the predicates PM3030- K110068 and Healthmate Pro-8B - K121757 in the device comparison Table 5.1 below. Detailed electrical characteristics are provided in Table 5.2.
{5}------------------------------------------------
Table 5.1 Device Comparison
:
| Model Name510(k) Number | New DeviceMaxpower relief (PM3032) | Predicate DevicePM3030K110068 | Predicate DevicePro-8ABK121757 | Comment |
|---|---|---|---|---|
| Manufacturer | OMRON HEALTHCARE | OMRON HEALTHCARE | Healthmate International | |
| Indications for use | This device is intended for therelief of pain associated withsore or aching muscles of thelower back, arms, legs,shoulder or foot due to strainfrom exercise or normalhousehold and work activities. | This device is intended forthe relief of painassociated with sore oraching, muscles of thelower back, arms, or legsdue to strain from exerciseor normal household andwork activities. | To be used for temporaryrelief of pain with soreand aching muscles in theshoulder, waist, back,neck upperextremities(arm), andlower extremities(leg).due to strain from exerciseor normal household workactivities. | Substantiallyequivalent |
| Prescriptive | No, OTC | No, OTC | No, OTC | Identical |
| Power Source(s) | two AAA alkaline batteries | two AAA alkaline batteries | Rechargeable battery | PM3030 andPM3032 identical |
| - Method of Line Current Isolation | N.A. not line powered | N.A. not line powered | N.A. not line powered | Identical all batterypowered |
| Patient Leakage Current - NormalCondition (uA) | 1 | <0.1 | Not specified | All three devicecomply with60601-1 leakagecurrentrequirements |
| Patient Leakage Current - Single FaultCondition (uA) | 8.9 max with mains(250vAC/60Hz) | N.A | Not specified | All three devicecomply with60601-1 leakagecurrentrequirements |
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| 510(k) SummaryPage 4 of 91/30/2015 | |||||
|---|---|---|---|---|---|
| Model Name510(k) Number | New DeviceMaxpower relief (PM3032) | Predicate DevicePM3030K110068 | Predicate DevicePro-8ABK121757 | Comment | |
| Average DC current through electrodeswhen device is on but no pulse arebeing applied (uA) | 0 (uA) | 0 (uA) | 0 (uA) | Identical | |
| Number of output Modes | 9 | 3 | 8 | ||
| Number of outputchannels | 1 ch | 1 ch | 2 ch | PM3030 andPM3032 identical | |
| Method of ChannelIsolation | None, single channel | None, single channel | Not specified | PM3030 andPM3032 identical | |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Not specified | PM3030 andPM3032 identical | |
| Software/Firmware/MicroprocessorControl | Microprocessor | Microprocessor | Not specified | PM3030 andPM3032 identical | |
| Automatic Overload Trip | No | No | Not specified | PM3030 andPM3032 identical | |
| Automatic No-Load Trip | Yes | No | No | PM3032 containscircuit which willstop stimulation ifpads are notproperly adhered | |
| Automatic shut Off | Yes | Yes | Yes | Identical | |
| User over ride control | User activated On/Off | User activated On/Off | User activated On/Off | Identical |
,
{7}------------------------------------------------
| Model Name510(k) Number | New DeviceMaxpower relief (PM3032) | Predicate DevicePM3030K110068 | Predicate DevicePro-8ABK121757 | Comment | |
|---|---|---|---|---|---|
| Indication display | ON/Off status | Yes | Yes | Yes | Identical |
| Low Battery | Yes | No | Yes | PM3032 andPro-8AB identical | |
| Voltage/CurrentLevel | Yes | Yes | Yes | Identical | |
| Timer Range (minutes) | 15 | 15 | 10-60 | ||
| Compliance with Voluntary standards | ES 60601-1, IEC 60601-1-2,IEC 60601-2-10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC60601-1-2, IEC 60601-2-10 | PM3032 complieswith currentlyrecognized version of60601-1 | |
| Compliance with 21 CFR 898 | Yes (by compliance with8.5.2.3 of ES 60601-1) | Yes | Not specified | PM3032 and PM3030identical | |
| Weight | Approx. 100g (incl. batteries) | Approx. 60g (incl.batteries) | Approx. 54g (incl.batteries) | Similar | |
| Dimensions (W x H x D) | 52(W)x112(H)x25(D)mm | 55(W)x95(H)x18(D) | 50(W)x93(H)x10(D) | Similar | |
| Patient contact | Long Life Pads | Long Life Pads | Not specified | Identical electrodepads. The Long LifePads (K120516) |
{8}------------------------------------------------
Table 5.2 Detailed Electrical Comparisons Maxpower relief (PM303) Compared on Predicate Pro-8AB K121757
Press Presses Previous Max Previous Max power
| Parameter | Maxpower relief (P13032) | Predicate Pro-8AB K121757 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | TAP | KNEAD | RUD | ARM | LBACK | LEG | FOOT | JOINT | SHLDR | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| MaximumOutputVoltage [V] | @500Ω66.3 | 51.1 | 42.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 43.9 | 54.0 | 85.8 | 41.9 | 42.0 | 83.9 | 44.0 | 85.9 | |
| @2kΩ87.6 | 67.9 | 55.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 81.9 | 102.0 | 145.9 | 77.8 | 79.9 | 145.6 | 83.9 | 145.4 | ||
| @10kΩ95.9 | 73.9 | 59.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 146.4 | 159.9 | 159.8 | 137.0 | 141.7 | 158.1 | 147.8 | 159.9 | ||
| MaximumOutputCurrent [mA] | @500Ω132.6 | 102.2 | 84.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 87.8 | 108.0 | 171.6 | 83.8 | 84.0 | 167.8 | 88.0 | 171.8 | |
| @2kΩ43.8 | 34.0 | 28.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 41 | 51.0 | 73.0 | 38.9 | 40.0 | 72.8 | 42.0 | 72.7 | ||
| @10kΩ9.6 | 7.4 | 6.0 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 14.6 | 16.0 | 16.0 | 13.7 | 14.2 | 15.8 | 14.8 | 16.0 | ||
| Duration of primary phase [usec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | |
| Pulse Duration [usec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | 90 | |
| Frequency [Hz] | 1-15.43 | 25.28-79.22 | 84.86-132 | 1-132 | 1-237.6 | 1-19.16 | 1-19.16 | 42.43-237.6 | 1-19.16 | 59 | 12-47 | 1.7 | 95 | 94 | 1.7-59 | 59 | 1.7-94 | |
| Formultiphasicwaveformsonly: | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| PhaseDuration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Net Charge(μC per pulse)(@500Ω) [μC] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | |
| Maximum Phase Charge(@500Ω) [μC] | 13.26 | 15.33 | 12.69 | 13.26 | 19.89 | 13.26 | 13.26 | 13.26 | 13.26 | 7.9 | 9.72 | 15.44 | 7.54 | 7.56 | 15.10 | 7.92 | 15.46 | |
| Maximum Current Density(@500Ω) [mA/cm²] | 3.03 | 2.33 | 1.93 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.38 | 4.16 | 6.62 | 3.23 | 3.24 | 6.47 | 3.39 | 6.62 | |
| Maximum Average Current(@500Ω) [mA] | 0.17 | 0.37 | 0.71 | 0.83 | 0.38 | 0.43 | 0.17 | 0.22 | 0.88 | 0.47 | 0.46 | 0.03 | 0.72 | 0.71 | 0.89 | 0.47 | 1.45 | |
| Maximum Average PowerDensity (@500Ω) [W/cm²] | 0.00017 | 0.00020 | 0.00039 | 0.00060 | 0.00015 | 0.00040 | 0.00016 | 0.00015 | 0.00082 | 0.00079 | 0.00095 | 0.00004 | 0.00116 | 0.00115 | 0.002 | 0.00079 | 0.00142 | |
| BurstMode | (a) Pulses perburst | 46 | 71 | 118 | 23 | 1425 | 57 | 57 | 1425 | 76 | 159 | 940 | N/A*** | 66 | 1786 | 940 | 295 | 1767 |
| (b) Bursts per sec | 0.33 | 0.59 | 0.59 | 1.00 | 0.14 | 0.25 | 0.25 | 0.14 | 0.20 | 0.24 | 0.05 | N/A*** | 0.87 | 0.04 | 0.05 | 0.15 | 0.05 | |
| **(c) Burstduration | 3 | 8.5 | 17 | 8 | 14 | 8 | 8 | 14 | 10 | 4.2 | 21.1 | N/A*** | 1.15 | 23 | 21.17 | 6.6 | 20.5 | |
| (d) Duty cycle:Line(b)xLine(c) | 1 | 5 | 10 | 8 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | N/A*** | 1 | 1 | 1 | 1 | 1 | |
| ON Time (seconds) | 3 | 0.9 | 0.9 | 0.3 | 6 | 3 | 3 | 6 | 4 | 2.7 | 20 | N/A*** | 0.7 | 19 | 20 | 5 | 18.8 | |
| OFF Time (seconds) | 0 | 0.8 | 0.8 | 0.7 | 1 | 1 | 1 | 1 | 1 | 1.5 | 11 | N/A*** | 0.45 | 4 | 1.17 | 1.6 | 1.7 | |
| Additional Features | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
{9}------------------------------------------------
Output Specifications Maxpower relief (PM3032) Compared to Predicate PM3030 K110068
| Parameter | Maxpower relief (PM3032) | Predicate PM3030 K110068 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Program Name | TAP | KNEAD | RUB | ARM | LBACK | LEG | FOOT | JOINT | SHLDR | Arm Mode | Lower Back Mode | Leg/foot Mode | |
| 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 | |
| Maximum OutputVoltage [V] | @500Ω | 66.3 | 51.1 | 42.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 66.3 | 34.4 | 33.0 | 34.2 |
| @2kΩ | 87.6 | 67.9 | 55.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 87.9 | 46.0 | 43.2 | 45.2 | |
| @10kΩ | 95.9 | 73.9 | 59.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 95.9 | 49.6 | 48.0 | 50.4 | |
| Maximum OutputCurrent [mA] | @500Ω | 132.6 | 102.2 | 84.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 132.6 | 68.8 | 66.0 | 68.4 |
| @2kΩ | 43.8 | 34.0 | 28.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 44.0 | 23.0 | 21.6 | 22.6 | |
| @10kΩ | 9.6 | 7.4 | 6.0 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 5.0 | 4.8 | 5.0 | |
| Duration of primary phase [μsec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Pulse Duration [μsec] | 100 | 150 | 150 | 100 | 150 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Frequency [Hz] | 1 - 15.43 | 25.28-79.22 | 84.86-132 | 1 - 132 | 1 - 237.6 | 1 - 19.16 | 1 - 19.16 | 42.43-237.6 | 1 - 19.16 | 2 - 51.65 | 2 - 108 | 2 - 11 | |
| For multiphasicwaveforms 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 | |
| Maximum Phase Charge (@500Ω) [μC] | 13.26 | 15.33 | 12.69 | 13.26 | 19.89 | 13.26 | 13.26 | 13.26 | 13.26 | 6.88 | 6.60 | 6.84 | |
| Maximum Current Density (@500Ω) [mA/cm²] | 3.03 | 2.33 | 1.93 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 3.03 | 1.57 | 1.51 | 1.56 | |
| Maximum Average Current (@500Ω) [mA] | 0.17 | 0.37 | 0.71 | 0.83 | 0.38 | 0.43 | 0.17 | 0.22 | 0.88 | 0.29 | 0.58 | 0.07 | |
| Maximum Average Power Density (@500Ω)[W/cm²] | 0.00017 | 0.00020 | 0.00039 | 0.00060 | 0.00015 | 0.00040 | 0.00016 | 0.00015 | 0.00082 | 0.00018 | 0.00035 | 0.00005 | |
| Burst Mode | (a) Pulses per burst | 46 | 71 | 118 | 23 | 1425 | 57 | 57 | 1425 | 76 | 180 | 540 | 33 |
| (b) Bursts per second | 0.33 | 0.59 | 0.59 | 1.00 | 0.14 | 0.25 | 0.25 | 0.14 | 0.20 | 0.11 | 0.10 | 0.17 | |
| **(c) Burst duration | 3 | 8.5 | 17 | 8 | 14 | 8 | 8 | 14 | 10 | 18 | 20 | 6 | |
| (d) Duty cycle:Line(b)xLine(c) | 1 | 5 | 10 | 8 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | |
| ON Time (seconds) | 3 | 0.9 | 0.9 | 0.3 | 6 | 3 | 3 | 6 | 4 | 8 | 10 | 6 | |
| OFF Time (seconds) | 0 | 0.8 | 0.8 | 0.7 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | |
| 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 |
(): Burst duration = pulse train duration
(): Burst duration = pulse train duration
(**): Endurande model Automode I doesn't have a burst mode
(*) burn duration = pulse train duration
(***): Endurmeds model Automode I doesn't have a built like those.
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Differences Between Other Legally Marketed Predicate Devices:
The Omron Maxpower relief (PM3032) is viewed as substantially equivalent to the predicate devices because: The Maxpower relief (PM3032) uses the exact same technology and has substantially equivalent indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Indications -
This device 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 and work activities. These indications are virtually identical to the predicates.
Prescriptive - The Maxpower relief (PM3032) and predicates are all OTC.
Design and Technology - The Maxpower relief (PM3032) has equivalent design and features when compared to the predicates and has the identical technology to the predicate PM3030.
Performance and Specifications - The Maxpower relief (PM3032) has equivalent specifications of performance when compared to the predicates.
Compliance with standards - The predicate devices declare compliance with IEC 60601-1 and IEC 60601-1-2. The PM3032 complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1) and IEC 60601-1-2. The Pro-8AB and PM3032 comply with IEC 60601-2-10. Additionally the PM3032 complies with IEC 60601-1-11 for home healthcare.
Materials -
The patient contacting materials of the Maxpower relief (PM3032) are the Long Life Pads. The Long Life Pads and were tested and the data presented in K 120516.
- Irritation and delayed-type hypersensitivity Extract in accordance with ISO 10993-10 .
- Closed-patch test for delayed hypersensitivity Rabbits in accordance with ISO . 10993-10
- Cytotoxicity in accordance with ISO 10993-5
Patient Population -
The Maxpower relief (PM3032) and predicates are indicated for adults
Environment of Use - Clinics, hospital and home environments. Identical to the predicate K110068
Non-Clinical Testing Summary:
The device has been tested to insure that all requirements have been met, this includes:
- . Testing of all controls
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- Testing of all indicators .
- . Testing of battery state indicators
- Testing of waveforms ●
The device has also been tested to the requirements of the following standards:
- AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: . general requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility -Requirements and Tests
- . IEC 60601-1-11: 2010, medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10: 2012 Medical electrical equipment part 2-10: particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
The device has also been tested for drop, vibration and environmental temperature and humidity
Usability testing has also been performed.
Clinical Testing Summary:
No clinical testing was performed
Substantial Equivalence Conclusion
Omron maintains that the Maxpower relief (PM3032)is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.
§ 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).