Healy

K191075 · Timewaver Production GmbH · NUH · Nov 22, 2019 · Neurology

Device Facts

• Record ID: K191075
• Device Name: Healy
• Applicant: Timewaver Production GmbH
• Product Code: NUH · Neurology
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Device Story

Healy is a single-channel, wearable, battery-powered electrotherapy device delivering microcurrent stimulation via reusable, self-adhesive electrodes. Operated by a physician, nurse, or patient in clinics, hospitals, or home environments, the device is controlled via a dedicated iOS or Android smartphone app or on-device controls. It transforms electrical energy into low-level, biphasic, rectangular microcurrent pulses to stimulate nerves/muscles. The app allows users to set therapy modes, intensity, and duration. Healthcare providers or patients use the output to manage pain; the device provides symptomatic relief for chronic, intractable, or exercise/strain-related pain. The system includes the main unit, electrode cables, adhesive electrodes, and a USB charger. It features automatic overload, no-load, and shut-off safety mechanisms.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electrical safety (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10), electromagnetic compatibility (EN 301 489-1 & 17), Bluetooth RF compliance (TCRL 2015-2), and software verification/validation per FDA guidance and EN 62304. Human factors analysis was conducted with no identified user issues.

Technological Characteristics

Wearable, single-channel, battery-powered (rechargeable Li-ion) microcurrent stimulator. Delivers biphasic rectangular waveforms. Materials: reusable self-adhesive electrodes (previously cleared). Connectivity: Bluetooth for smartphone app control. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 21 CFR 898. Software-controlled current and voltage regulation. Dimensions: 55x55x7mm unit.

Indications for Use

Indicated for adults 18 years and older for temporary relief of pain in shoulder, waist, back, arms, and legs due to exercise or household strain, and for symptomatic relief/management of chronic, intractable pain and arthritis-associated pain. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic or 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

• Avail, Model PM601 (K172079)

Submission Summary (Full Text)

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November 22, 2019

TimeWaver Production GmbH % Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave, SW #43083 Grandville, Michigan 49418

Re: K191075

Trade/Device Name: Healy 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 30, 2019 Received: November 12, 2019

Dear Douglas Herrington:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Pamela Scott 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

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## Indications for Use

510(k) Number (if known) K191075

Device Name Healy

Indications for Use (Describe)

The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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: K191075

#### General Information

Date: May 26, 2019

Applicant & Manufacturing Address:

TimeWaver Production GmbH Schloss Kränzlin, Darritzer Straße 6 Kränzlin, Germany 16818 Phone: [phone] FAX: [phone] Registration Number: 3009411292

#### Contact Name

Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave SW#43083 Grandville, MI 49418-1342 Telephone: [phone] Fax: [phone] E-mail: dgls [e-mail]

#### Regulatory Information

Device Name: Healy 510(K) Number: K191075 Classification: Class II Panel: Neurological Therapeutic Devices Product Code: NUH, NYN Regulation Number: 21 CFR 882.5890, Transcutaneous electrical nerve stimulator for pain relief

#### Indication for Use Statement

The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities. And for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Environments of Use: Clinics, hospital and home environments.

Patient Population: All adults 18 years and older.

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## 510(k) Summary: k191075

## Substantial Equivalence Summary

| Table 1: Substantial | | | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalence Comparison Table | Microcurrent | Microcurrent | Comparison |
| 510(k) Number | K191075 | K172079 | |
| Regulation | 21 CFR§882.5890 | 21 CFR§882.5890 | No Difference |
| Product Code | NUH, NYN | NUH | Similar, Healy adds product code<br>NYN, however Omron's IFU states<br>arthritis pain treatment but the 510k<br>approval is for only NUH. |
| Device Name | Healy | Avail, Model PM601 | |
| Manufacturer | TimeWaver Production GmbH | Omron Healthcare Inc | |
| Usage | Over the Counter | Over the Counter | No Difference |
| Intended Use | The Healy is intended for the relief<br>of pain associated with sore or<br>aching muscles of the lower back,<br>arms, legs, shoulders or feet due to<br>strain from exercise or normal<br>household work activities.<br>For the symptomatic relief and<br>management of chronic, intractable<br>pain and relief of pain associated<br>with arthritis. | The Avail is intended for the relief<br>of pain associated with sore or<br>aching muscles of the lower back,<br>arms, legs, shoulders or feet due to<br>strain from exercise or normal<br>household work activities.<br>When used for the symptomatic<br>relief and management of chronic,<br>intractable pain and relief of pain<br>associated with arthritis, use the<br>Tap, Shoulder, Arm or Leg mode<br>of stimulation. | No Difference |
| Environment of Use | Environments of Use: Clinics,<br>hospital and home environments. | Environments of Use: Clinics,<br>hospital and home environments. | No Difference |
| Patient Population | Patient Population: All adults 18<br>years and older. | Patient Population: All adults 18<br>years and older. | No Difference |
| Contraindications/<br>Warnings/<br>Precautions | Contraindications: Do not use this<br>device if you have a cardiac<br>pacemaker, implanted defibrillator,<br>or other implanted metallic or | Contraindications: Do not use this<br>device if you have a cardiac<br>pacemaker, implanted defibrillator,<br>or other implanted metallic or | No Difference |

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#### 510(k) Summary: TimeWaver Production GmbH

| | electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | No Difference |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Single Use | | | |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | No Difference |
| Over-the-Counter: (OTC) | Yes | Yes | No Difference |
| Power Source: Voltage | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | No Difference |
| Method of Line Current Isolation | N/A (internal power source) | N/A (internal power source) | No Difference |
| Patient Leakage Current | | | |
| -normal Condition, uA | 0 | <10 | Similar with Healy having somewhat lower leakage current |
| - Fault Condition, uA | 0 | <50 | Similar with Healy having somewhat lower leakage current |
| Average DC Current Through electrodes when device is on but no pulses are being applied (uA) | <1 | 0.0 | No Difference |
| Number of Output Modes | 1 Microcurrent mode | 1 Microcurrent mode<br>9 TENS modes | No Difference as Healy only compares to the Microcurrent mode. |
| Number of Output Channels | 1 | 1 | No Difference |
| Synchronous or Alternating | N/A | N/A | No Difference |
| Method of Channel Isolation | none | none | No Difference |
| Regulated Current or Regulated Voltage | both (Software control) | current | Similar with Healy providing both current and voltage regulation. |
| Software/Firmware/Microprocessor Control? | Microprocessor | Microprocessor | No Difference |
| Automatic Overload Trip | Yes | no | Similar with Healy adding an additional safety feature. |
| Automatic No Load contact Trip | Yes | yes | No Difference |
| Automatic Shut Off | Yes | yes | No Difference |
| User Override Control? | Yes, power On/Off button on the device and in the App software | Yes, power On/Off button on the device and in the App software | No Difference |
| Indicator Display | | | |

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#### 510(k) Summary: TimeWaver Production GmbH

| On/Off Status | Yes, on the App and LED indicator<br>on Main unit | Yes, on the App and LED<br>indicator on Main unit | No Difference |
|-----------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low Battery? | Yes on app and LED indicator on<br>device | YES, ON APP | No Difference |
| Voltage/Current | YES, ON APP | YES, ON APP | No Difference |
| Timer Range (minutes) | 1min - 180min | 5-60 minutes and<br>30-180 minutes for Microcurrent | Similar with Heal having additional<br>timing control of 1- 30 minutes |
| Compliance With Voluntary<br>standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11 | No Difference |
| Compliance with 21 CFR 898 | Yes | N/A no patient cable | Different with Healy complying with<br>21 CFR 898. |
| Weight | device 34g<br>electrode 2g | Device: Approx. 42 g<br>Pad-L: Approx. 21 g<br>Pad-M: Approx. 17.5g<br>Charger: Approx. 100g | Healy is lighter than the SE as the<br>pads are smaller and no charger is<br>provided. |
| Dimensions (W x H x D). mm | device : 55 x 55 x 7<br>pads: 32mm round x 5mm height | Device: Approx. 60 × 72 × 15.5<br>Charger: Approx. 158 x 90 x 20.5<br>Pad-L: Approx. 219 × 83.5 × 9.3<br>Pad-M: Approx. 180 × 79.5 × 9.3 | Healy pads are smaller than the<br>predicate because they do not deliver<br>TENS voltages/currents, and no<br>charger is provided. See the technical<br>discussion. |
| Operating Conditions | 5°C - 40°C<br>15-93%RH<br>700-1060hpa | 10 to 40 °C<br>30 to 80 %RH<br>700 to 1060 hPa (noncondensing) | Similar with Healy having slight<br>higher relative humidity |
| Charging Conditions | 5-40°C<br>15-93% RH. | 5 to 35 °C<br>30 to 80 %RH | Similar with Healy having slight<br>higher relative humidity |
| Storage Conditions | 5-40°C<br>15-93% RH. | 0 to 40 °C<br>30 to 80 % RH | Similar with Healy having slight<br>higher relative humidity and slightly<br>lower temperature |
| Transporting Conditions | -20 to 60 °C<br>15-93% RH | -20 to 60 °C<br>10 to 90 % RH | Similar with Healy having slight<br>higher relative humidity and slightly<br>lower temperature |
| Electrode Style | Reusable | Reusable | No Difference |

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| 510(k) Summary: TimeWaver Production GmbH | | | |
|-------------------------------------------|--|--|--|
|-------------------------------------------|--|--|--|

| Table 2: Output Comparison | | | |
|------------------------------------------|---------------------------|----------------------|---------------------------------------------------------------|
| Microcurrent mode | | | |
| 510(k) Number | K191075 | K172079 | Comparison |
| Product Code | NUH, NYN | NUH | |
| Device Name | Healy | Avail, Model PM601 | |
| Manufacturer | TimeWaver Production GmbH | Omron Healthcare Inc | |
| Waveform | Biphasic | Biphasic | No Difference |
| Shape | Rectangular | Rectangular | No Difference |
| Max Output Voltage (V) | | | |
| 500 Ohms | 0.030 | 0.025 | Similar with Healy having<br>slightly higher output current. |
| 2k Ohms | 0.100 | 0.100 | No Difference |
| 10k Ohms | 0.500 | 0.500 | No Difference |
| | | | |
| Maximum Output Current (mA) | | | |
| 500Ohm | 0.050 | 0.050 | No Difference |
| 2kOhm | 0.050 | 0.050 | No Difference |
| 10kOhm | 0.050 | 0.050 | No Difference |
| Pulse Duration, Sec | 2.50 | 2.50 | No Difference |
| Frequency, Hz | 0.20 | 0.20 | No Difference |
| Net Charge (uC per charge) @ 500<br>ohms | 0 | 0 | No Difference |
| Maximum Phase Charge (uC), 500<br>Ohms | 125.0 | 125.0 | No Difference |
| Maximum Average Current, mA | 0.025 | 0.025 | No Difference |
| Maximum Current Density,<br>mA/cm² | | | |
| 500 Ohms | 0.0010 | 0.0008 | Similar with Healy having<br>slightly higher current density. |
| 2k Ohms | 0.001 | --- | Unknown as the predicate does<br>not give a value |
| 10k Ohms | 0.001 | --- | Unknown as the predicate does<br>not give a value |

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#### 510(k) Summary: TimeWaver Production GmbH

| Maximum Average Power<br>[mW/cm²] | | | |
|-----------------------------------|------------|------------|------------------------------------------------------------------------|
| 500Ohm | 0.00002500 | 0.00001398 | Similar with Healy having<br>slightly higher maximum<br>average power. |
| 2kOhm | 0.0000100 | ---- | The predicate does not mention<br>the value |
| 10kOhm | 0.0000500 | ---- | The predicate does not mention<br>the value |
| Regulated Current or Voltage? | Current | Current | No Difference |

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# 510(k) Summary: k191075

## Discussion of Healy and Avail similarities and differences

#### PREDICATE DEVICE(S) [807.92(a)(3)]

The Healy device is substantially equivalent to the primary predicate device, the Omron Avail Microcurrent mode (K172079) with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological and safety characteristics.

### DEVICE DESCRIPTION [807.92(a)(4)]

The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body.

The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls. The Healy will be packaged with an Instruction Manual and quick start guide that provides details on setting up the device for use, installing of the App, setting and controlling therapy modes, and troubleshooting. The system includes the unit, adhesive gel electrodes, USB charging cable, electrode connection cable, and storage case.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES, [807.92(a)(6)]

In regard to technological characteristics, the Healy device is similar to the predicate with only minor technological differences. Like the predicate Avail device is paired and controlled by a dedicated smartphone App and on product controls with treatment duration and intensity being controlled by the App or product controls. However, both proposed and predicate devices can be turned off by pressing the on/off button on the main unit or the App. The Healy device and the Avail both offer one microcurrent mode. The Healy and Avail both use biphasic rectangular waveform. Both products use microcurrent lowlevel electrical stimulation and share the same regulation number (21 CFR 882.5890) the same product codes of NUH and NYN. The Avail instruction booklet (pg 26 of the attached Avail IB) states. "Any of the modes can be used on body parts or pains described in this instruction manual of the device", which includes the microcurrent mode.

The microcurrent mode is considered a very low current TENS (rectangular biphasic waveform) delivered at a low frequency. A comparison of the Healy operating characteristics to the primary predicate is included in the 510k summary.

In general, the Healy output parameters fall within the range of output parameters for Avail. For example, the maximum current density (mA/cm2) range for Healy @ 500 ohms is 0.0010, while the Avail is 0.0008. 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) @500 ohms is 0.00002500 for Healy, whereas the Avail maximum average power density @500 ohms is 0.00001398.

The Healy and Avail differ in how the electrode pads are configured. The Avail has pads that do not use lead wires, where the Healy does use lead wires. Additionally, the Healy pads are 32mm round where the Avail is 180 x 80mm because Healy only delivers microcurrent stimulation whereas the Avail also delivers TENS voltages and currents. The Healy electrodes and cables comply with 21 CFR 898 so thev do not raise new questions of safety or effectiveness.

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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. TimeWaver has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation to ensure that the Healy device performs as intended. The Healy also passed all testing requirements for electrical safety and EMC, and the device electrode has been previously cleared by FDA. 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 Healy is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed Healy device and the predicate device is included in the 510k summary.

### Performance Data [807.92(b)]

All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended.

#### Nonclinical Testing Summarv:

The nonclinical, bench testing included performance verification to confirm acceptable performance of device features and functions. Other nonclinical safety testing included:

- · 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 Healy meet the established specifications.

### Performance Data: Electromagnetic Compatibility and Electrical Safety

The Healy device has been thoroughly tested against applicable EN and IEC standards by a third p arty and found to be in compliance with the applicable sections. It was functionally tested and found to be in compliance with the specification.

The applicable electrical and safety standards met are:

| IEC 60601-1: | Medical electrical equipment - Part 1: General requirements for basic safety and<br>essential performance |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |
| IEC 60601-1-11: | Medical electrical equipment - Part 1-11: General requirements for basic safety and<br>essential performance - Collateral Standard: Requirements for medical electrical<br>equipment and medical electrical systems used in the home healthcare environment |
| IEC 60601-2-10: | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety<br>and essential performance of nerve and muscle stimulators |

EN 301 489-1 &17: Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment

TCRL 2015-2: Bluetooth RF Compliance

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## 510(k) Summary: TimeWaver Production GmbH

## Software Validation

The Healy device software was validated following FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.

The applicable software validation standards met are: EN 62304 Medical device software - Software life cycle processes EN ISO 13485: 2012 Medical devices-Quality management systems-Requirements for regulatory purposes EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices EN 62304: 2006 Medical device software - Software life cycle processes EN 62366: 2008 Medical devices - Application of usability engineering to medical devices

### Biocompatibility Data

Biocompatibility testing is not required because the only patient contact surface is through the electrode which was previously cleared by FDA.

## Non-Clinical Testing - Other

In addition to electrical safety testing and software validation, human factors analysis and testing was also conducted and no user issues were identified.

## Conclusion

Based upon the intended use and technical information provided in this pre-market notification, the Healy device has been shown to be safe and effective and substantially equivalent to the currently marketed predicate device.