Maxpower Relief

K182120 · Omron Healthcare, Inc. · NUH · Jan 10, 2019 · Neurology

Device Facts

• Record ID: K182120
• Device Name: Maxpower Relief
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Jan 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

Device Story

Small, battery-operated TENS device for OTC pain relief; applies electrical stimulation via electrode pads to lower back, arms, legs, shoulder, or foot. User selects stimulation modes; device delivers regulated current pulses to nerves/muscles. Used in home, clinic, or hospital settings by adult patients. Output affects pain perception; provides symptomatic relief for muscle strain, chronic intractable pain, and arthritis. Device is software-controlled; includes automatic shut-off and no-load trip features. No connection to AC mains or other devices.

Clinical Evidence

No clinical data. Bench testing only, including verification of controls, indicators, battery state, waveforms, and compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10 standards. Biocompatibility assessed per ISO 10993-1 for limited duration skin contact.

Technological Characteristics

Battery-operated (2x AAA) TENS stimulator; regulated current output; 9 stimulation modes; 1 output channel. Patient-contacting materials (Long Life Pads) identical to predicate. Complies with ES60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11. Non-sterile, surface-contacting device.

Indications for Use

Indicated for adults for relief of pain in lower back, arms, legs, shoulder, or foot due to exercise or household strain; includes symptomatic relief/management of chronic, intractable pain and arthritis-related pain using Shoulder mode. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices.

Regulatory Classification

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.

Predicate Devices

• Omron - PM3032 (K141978)
• Omron - Avail (K172079)

Submission Summary (Full Text)

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January 10, 2019

Omron Healthcare, Inc. % Paul Dryden Consultant Omron Healthcare, Inc. c/o ProMedic, LLC. 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K182120

Trade/Device Name: Omron Healthcare Maxpower Relief Model PM3032B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: October 11, 2018 Received: October 12, 2018

Dear Paul Dryden:

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 mav, 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 avare 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Pamela D. Scott -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K182120

Device Name

Omron Healthcare Maxpower Relief Model PM3032B

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder 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)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary Page 1 of 10 1/7/2019

| Omron Healthcare, Inc.<br>1925 West Field Court<br>Lake Forest, IL 60045 USA | Tel - 847-247-5626 |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Fax- 847-680-6269 |
| Official Contact: | Renee Thornborough – Executive Director QA/RA |
| Proprietary or Trade Name: | Omron Healthcare Maxpower Relief Model PM3032B |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Classification Name/Code:<br>21CFR 882.5890 | NUH - stimulator, nerve, transcutaneous, over-the-counter<br>NYN - stimulator, electrical, transcutaneous, for arthritis<br>Class II |
| Device Name: | Omron Healthcare Maxpower Relief Model PM30321 |
| Predicate Devices: | K141978 - Omron - PM3032<br>K172079 – Omron - Avail |

#### Device Description:

The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11.

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.

The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics.

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 work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. These are identical to the accessories cleared in K141978.

As above the device is battery powered there is no connection to AC mains supply nor connection to any other device.

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#### 510(k) Summary Page 2 of 10 1/7/2019

This submission is for expanding the indications for use to include indications associated with product code NYN. The device is identical to the Maxpower Relief (Model PM3032) cleared under K141978 except the CPU and related components are changed for cost saving purpose. UDI has also added on the main unit and the packaging. There are no other changes (appearance, dimension, materials, waveforms, modes). The accessories are identical to the Maxpower Relief (Model PM3032) cleared under K141978

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 2 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 work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation.

#### Environment of Use:

Clinics, hospital and home environments

#### 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.

#### Predicate Device Comparison:

Table 1 outlines the features of the Omron Healthcare Maxpower Relief Model PM3032B and compares it to the predicates that are being used to establish substantial equivalence.

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# 510(k) Summary

#### Device Comparison

| | New Device | Primary Predicate | Secondary Predicate | Comment | |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Feature | Omron Healthcare<br>Maxpower Relief Model | Device<br>PM3032 | Device<br>Omron Avail | | |
| | PM3032B | (MaxPower relief) | K172079 | | |
| | | K141978 | | | |
| Indications for use | This device is intended for the<br>relief of pain associated with<br>sore or aching, muscles of the<br>lower back, arms, legs,<br>shoulder, or foot due to strain<br>from exercise or normal<br>household work activities.<br>When used for the<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief of<br>pain associated with arthritis,<br>use the Shoulder mode of<br>stimulation.<br>Environments of Use: Clinics,<br>hospital and home<br>environments<br>Patient Population: Adult | This device is intended<br>for the relief of pain<br>associated with sore or<br>aching, muscles of the<br>lower back, arms, legs,<br>shoulder, or foot due to<br>strain from exercise or<br>normal household work<br>activities.<br>Environments of Use:<br>Clinics, hospital and<br>home environments<br>Patient Population: Adult | The Avail is intended for<br>the relief of pain<br>associated with sore or<br>aching muscles of the<br>lower back, arms, legs,<br>shoulders or feet due to<br>strain from exercise or<br>normal household work<br>activities.<br>When used for the<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis, use the Tap,<br>Shoulder, Arm or Leg<br>mode of stimulation.<br>Environments of Use:<br>Clinics, hospital and<br>home environments<br>Patient Population: Adult | Identical to<br>Maxpower Relief<br>for temporary<br>relief of pain with<br>sore and aching<br>muscles.<br>Similar to Avail<br>with respect to<br>symptomatic relief<br>and management<br>of chronic,<br>intractable pain,<br>and relief of pain<br>associated with<br>arthritis. | |
| Environments of Use: | Clinics, hospitals and home<br>environments | Clinics, hospitals and<br>home environments | Clinics, hospitals and<br>home environments | Identical | |
| Patient Population | Adult | Adult | Adult | Identical | |
| Classification - Regulation | 21 CFR §882.5890,<br>Transcutaneous electrical | 21 CFR §882.5890,<br>Transcutaneous electrical | 21 CFR §882.5890,<br>Transcutaneous electrical | Identical | |
| Feature | New Device<br>Omron Healthcare<br>Maxpower Relief Model<br>PM3032B | Primary Predicate<br>Device<br>PM3032<br>(MaxPower relief)<br>K141978 | Secondary Predicate<br>Device<br>Omron Avail<br>K172079 | Comment | |
| | nerve stimulator for pain<br>relief | nerve stimulator for pain<br>relief | nerve stimulator for pain<br>relief | | |
| Classification - Product Code | Primary: NUH - stimulator,<br>nerve, transcutaneous, over-<br>the-counter<br>Secondary: NYN - stimulator,<br>electrical, transcutaneous, for<br>arthritis. | NUH - stimulator, nerve,<br>transcutaneous, over-the-<br>counter | Primary: NUH -<br>stimulator, nerve,<br>transcutaneous, over-the-<br>counter<br>Secondary: NYN -<br>stimulator, electrical,<br>transcutaneous, for<br>arthritis. | Proposed device<br>and secondary<br>predicate device<br>have the same<br>medical device<br>product code. | |
| Prescriptive | No, OTC | No, OTC | No, OTC | Identical | |
| Contraindications/Warning/Precautions | Contraindications<br>Do not use this device if you<br>have a cardiac pacemaker,<br>implanted defibrillator, or<br>other implanted metallic or<br>electronic device. Such use<br>could cause electric shock,<br>burns, electrical interference,<br>or death. | Contraindications<br>Do not use this device if<br>you have a cardiac<br>pacemaker, implanted<br>defibrillator, or other<br>implanted metallic or<br>electronic device. Such<br>use could cause electric<br>shock, burns, electrical<br>interference, or death. | Contraindications<br>Do not use this device if<br>you have a cardiac<br>pacemaker, implanted<br>defibrillator, or<br>otherimplanted metallic<br>or electronic device. Such<br>use could cause electric<br>shock, burns, electrical<br>interference, or death. | Identical | |
| Single Use | Pads are for single patient use | Pads are for single patient<br>use | Patient-contacting Pads<br>are for single patient use | Identical to<br>MaxPower Relief | |
| Sterility | External contacting device,<br>nonsterile | External contacting<br>device, nonsterile | External contacting<br>device, nonsterile | Identical | |
| Over-the-Counter (OTC) | Yes | Yes | Yes | Identical | |
| | | | | | |
| 1/7/2019 | | | | | |
| Feature | | New Device<br>Omron Healthcare<br>Maxpower Relief Model<br>PM3032B | Primary Predicate<br>Device<br>PM3032<br>(MaxPower relief)<br>K141978 | Secondary Predicate<br>Device<br>Omron Avail<br>K172079 | Comment |
| Power Source(s) | | Two AAA alkaline batteries | Two AAA alkaline<br>batteries | Rechargeable lithium Ion<br>battery | Identical to<br>Maxpower Relief |
| - Method of Line Current Isolation | | N.A.(internal power source) | N.A.(internal power<br>source) | N.A.(internal power<br>source) | Identical |
| Patient Leakage Current - Normal<br>Condition (uA) | | 1 | 1 | <10uA | Identical to<br>Maxpower Relief |
| Patient Leakage Current - Single Fault<br>Condition (uA) | | 8.9 max | 8.9 max | <50uA | Identical to<br>Maxpower Relief |
| Average DC current through electrodes<br>when device is on but no pulse are<br>being applied (uA) | | 0 (uA) | 0 (uA) | 0 (uA) | Identical |
| Number of output Modes | | 9 TENS modes | Same | 9 TENS modes<br>1 Microcurrent mode | Identical to<br>Maxpower Relief |
| Number of output<br>channels | Synchronous or<br>Alternating | 1 ch | 1 ch | 1 ch | Identical |
| | Method of Channel<br>Isolation | None | None | None | Identical |
| | Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Regulated Current | Identical |
| Software/Firmware/Microprocessor<br>Control | | Microprocessor | Microprocessor | Microprocessor | Identical |
| Automatic Overload Trip | | No | No | No | Identical |
| Automatic No-Load Trip | | Yes | Yes | Yes | Identical |
| Automatic shut Off | | Yes | Yes | Yes | Identical |
| | Feature | New Device<br>Omron Healthcare<br>Maxpower Relief Model<br>PM3032B<br>1/7/2019 | Primary Predicate<br>Device<br>PM3032<br>(MaxPower relief)<br>K141978 | Secondary Predicate<br>Device<br>Omron Avail<br>K172079 | Comment |
| | User over ride control | Yes, Power On/Off button | Yes, Power On/Off<br>button | Yes, Power On/Off<br>button on the device and<br>in the App software | Identical to<br>Maxpower Relief |
| | Indication display | ON/Off status | Yes | Yes on App and LED<br>indicator on main unit | Identical to<br>Maxpower Relief |
| | | Low Battery | Yes | Yes on App | Identical to<br>Maxpower Relief |
| | | Voltage/Current<br>Level | Yes | Yes on App | Identical to<br>Maxpower Relief |
| | Timer Range (minutes)…