StimaWELL 120MTRS

K181645 · Pierenkemper GmbH · GZJ · Aug 13, 2020 · Neurology

Device Facts

• Record ID: K181645
• Device Name: StimaWELL 120MTRS
• Applicant: Pierenkemper GmbH
• Product Code: GZJ · Neurology
• Decision Date: Aug 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TENS mode: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-tramautic acute pain and post surgical pain Russian mode: - Temporary relaxation of muscle spasms in back area - Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles

Device Story

StimaWELL 120MTRS is a 12-channel electro-therapy system for muscle stimulation, pain relief, and back warming. System comprises a stimulation mat, controller, and remote control. Inputs include user-selected treatment sequences via touchscreen or chip cards. Device transforms electrical energy into medium-frequency alternating current (MFAC) or modulated low-frequency alternating current to stimulate nerves and muscles; resistive heating elements provide warming. Output is delivered through the mat electrodes to the patient's back. Used in clinical or home settings; operated by patients or clinicians. Remote control allows patients to pause treatment and adjust intensity. Output affects clinical decision-making by providing non-pharmacological pain management and muscle therapy. Benefits include pain relief, muscle spasm reduction, and atrophy prevention.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through electrical safety, EMC, biocompatibility (ISO 10993), risk management (ISO 14971), software (IEC 62304), and usability (IEC 62366) testing.

Technological Characteristics

Materials: ABS plastic. Energy: AC powered (100-240V, 50/60Hz). Stimulation: 12-channel mat, MFAC and modulated LFAC. Heating: Resistive heating in mat. Connectivity: Touchscreen controller, chip card interface, remote control. Software: Microprocessor-controlled. Safety: Double isolation, patient leakage <0.063 mA (single fault).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-traumatic acute pain, or post-surgical pain (TENS mode), and for patients requiring temporary relaxation of back muscle spasms or prevention/retardation of lumbar paraspinal muscle disuse atrophy (Russian mode).

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

• Neurodyn II Ibramed Equipamentos Medico (K131917)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 13, 2020

Pierenkemper GmbH % Andre Kindsvater Senior Consultant RA & QA Emergo Global Consulting 2500 Bee Cave Rd, Building 1, Suite 300 Austin, Texas 78746

Re: K181645

Trade/Device Name: StimaWELL 120MTRS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: May 10, 2020 Received: May 15, 2020

Dear Andre Kindsvater:

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,

Amber Ballard, PhD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181645

Device Name StimaWELL®120MTRS

### Indications for Use (Describe)

TENS mode:

- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-tramautic acute pain and post surgical pain

Russian mode:

- Temporary relaxation of muscle spasms in back area
- Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles

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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# 510(k) Summary

## StimaWELL 120MTRS

# K181645

#### 1. Submission Sponsor

Pierenkemper GmbH Am Geiersberg 6 35630 Ehringshausen Germany

Phone: [phone] Fax: [phone] Contact: Thorsten Reichel Title: Technical Director

#### 2. Submission Correspondent

Emergo Global Consulting 2500 Bee Cave Rd, Suite 300 Austin, TX 78746 Cell Phone: [phone] Office Phone: [phone]

Fax: [phone] Contact: André Kindsvater, Senior Consultant, RA/QA Email: [e-mail].

#### 3. Date Prepared

August 6th, 2020

#### 4. Device Identification

| Trade/Proprietary Name: | StimaWELL 120MTRS |
|-------------------------|-----------------------------------------------------------------------------------------|
| Common/Usual Name: | Nerve and Muscle stimulator for pain relief |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief<br>Powered muscle stimulator |
| Regulation Number | 882.5890<br>890.5850 |
| Product Codes | GZJ<br>IPF |
| Regulation Name | Stimulator, Nerve, Transcutaneous, For Pain Relief<br>Stimulator, Muscle,Powered |

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#### 5. Legally Marketed Predicate Devices

a) Electro-therapy (primary) K131917, Neurodyn II Ibramed Equipamentos Medico, Sao Paulo, Brasil

#### 6. Device Description

The StimaWELL 120MTRS has been designed for the use of medium frequency electro-therapy for muscle stimulation and pain relief therapy as well as for the warming and wellness application in the back region.

The device consists of a 12 channel (electrodes) Stimulation Mat, a Controller and a Remote Control Unit. Various accessories (see 11.3.2 below) support the StimaWELL. The warming is provided through controlled resistive heating of the stimulation mat.

Interaction with the device is via a touchscreen on the controller. Selection and set-up of various treatment sequences is via the controller touchscreen or can be recalled from chip cards. The patient can interact with the device by using the remote control unit. With that he can pause the treatment at any time and also adjust the overall intensity.

#### 7. Indication for Use Statement

TENS mode: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain

- Temporary relaxation of muscle spasms in back area Russian mode: - Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles
#### 8. Substantial Equivalence Discussion

The following tables compares the Muscle StimaWELL 120MTRS to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

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| Manufacturer | Pierenkemper GmbH | IBRAMED EQUIPAMENTOS MEDICOS |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | StimaWELL 120MTRS | Neurodyn II |
| 510(k) Number | K181645 | K131917 |
| Product Code | GZJ<br>IPF | GZJ<br>IPF<br>GZI |
| Regulation Number | 882.5890<br>890.5850 | 882.5890<br>890.5850<br>882.5810 |
| Regulation Name | Transcutaneous electrical nerve<br>stimulator for pain relief | Transcutaneous electrical nerve<br>stimulator for pain relief |
| | Powered muscle stimulator | Powered muscle stimulator |
| | | External functional neuromuscular<br>stimulator |
| | Indications for Use | N/A<br>The StimaWELL is not used as a FES<br>device |
| TENS mode:<br>- Symptomatic relief of chronic (long<br>term) intractable pain<br>- Symptomatic relief of post-traumatic<br>acute pain and post surgical pain | | As a TENS device:<br>- Symptomatic relief of chronic (long<br>term) intractable pain<br>- Symptomatic relief of post-traumatic<br>acute pain and post surgical pain |
| Russian mode:<br>- Temporary relaxation of muscle<br>spasms in back area<br>- Prevention or retardation of disuse<br>atrophy of the lumbar paraspinal<br>muscles | | As a Burst Modulated Alternating<br>Current<br>(Russian) device:<br>- Temporary relaxation of muscle<br>spasms<br>- Prevention or retardation of disuse<br>atrophy in post-injury type conditions<br>- Increase local blood circulation<br>- Muscle re-education<br>- Maintaining or increasing range of<br>motion |
| Technological<br>characteristic | Medium-frequency<br>alternating current (MFAC);<br>modulated low-frequency alternating<br>current | Medium-frequency<br>alternating current (MFAC);<br>Low-frequency alternating current<br>(LFAC) |

Table 5-1 – Comparison of Characteristics

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| Electro-therapy<br>Mechanism of Action | Transcutaneous muscle stimulation | Transcutaneous muscle stimulation |
|------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------|
| Operating Modes:<br>TENS<br>Russian<br>FES | Yes<br>Yes<br>No | Yes<br>Yes<br>Yes |
| Setting of Mat Size | yes | N/A |
| Treatment Timer | 20-30 minutes | Not publicly available |
| Automatic Shutoff | No | No |
| Device Material | ABS Plastic and LCD display | ABS Plastic and LCD display |
| Number of Channels | 12 | 4 |
| Technology Overview<br>Software Micro-<br>processor | Yes | Yes |
| Method of line<br>current isolation | Double Isolation | Double Isolation |
| Patient leakage<br>control-normal<br>condition | < 0.041 mA | 0.0347mA |
| Patient leakage<br>control-single fault<br>condition | < 0.063 mA | 0.0162mA |
| Duration of<br>stimulation | 30 minutes | Not publicly available |
| Mode of operation | Continuous | Continuous |
| Energy Output | Yes | Yes |
| Sterile | No | No |
| Single-Use | No | No |
| AC Powered | 100 to 240V<br>50/60Hz | 100 to 240V<br>50/60Hz |
| Operating<br>Environment | 50°F - 104 °F<br>(10° C - 40° C)<br>30%-90% relative humidity<br>700 hPa to 1060 hPa | 41°F to 113°F<br>(5°C- 45°C) |
| Storage and<br>Transport<br>Environment | 14°F - 131 °F<br>(-10 °C to 55 °C)<br>30%-90% relative humidity<br>500 hPa to 1060 hPa | 59°F to 104°F<br>(15°C- 40°C) |
| Complies with ISO<br>10993-1 | Yes | Not publicly available |
| Electrical Safety<br>Testing Passed | Yes | Yes |

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## 9. Comparison of Output Specifications (per Section 3)

### Table 5-2 TENS Mode

| Trade Name > | StimaWELL 120MTRS | Neurodyn II |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------|
| a) Waveform<br>(e.g., pulsed monophasic, biphasic) | biphasic | Not publicly available |
| b) Shape<br>(e.g., rectangular, spike, rectified<br>sinusoidal) | rectangular | Not publicly available |
| c) Maximum Output Voltage<br>(specify units) | | Not publicly available |
| @ 500 Ω, | 58.7 Vpp<br>(+/- 10 %) | Not publicly available |
| @ 2 kΩ | 57.6 Vpp<br>(+/- 10 %) | Not publicly available |
| @ 10 kΩ | 68.3 Vpp<br>(+/- 10 %) | Not publicly available |
| d) Maximum Output Current<br>(specify units) | | 0 to 120mA peak to peak |
| @ 500 Ω, | 58.7 mA<br>(+/- 10 %) | 124mA<br>Tolerance not publicly available |
| @ 2 kΩ | 14.4 mA<br>(+/- 10 %) | 110mA<br>Tolerance not publicly available |
| @ 10 KΩ | 3.42 mA<br>(+/- 10 %) | 39.2mA<br>Tolerance not publicly available |
| e) Pulse Width (specify units) | 500 ms to 5 ms | Not publicly available |
| f) Frequency (Hz) | 1 Hz to 100 Hz | 0.5 Hz to 250Hz |
| g) For interferential modes only:<br>Beat Frequency (Hz) | N / A | Not publicly available |
| h) For multiphasic waveforms only:<br>Phase<br>Symmetrical phases? (yes/no),<br>Phase Duration (include units)<br>(state range, if applicable) (both phases,<br>if asymmetrical) | N / A (Biphasic is<br>noted above) | Not publicly available |
| i) Net Charge (μC per pulse) @ 500 Ω<br>(If zero, state method of achieving zero<br>net charge.) | N / A | Not publicly available |
| j) Maximum Phase Charge, (μC) @ 500 Ω | N / A | Not publicly available |
| Trade Name > | StimaWELL 120MTRS | Neurodyn II |
| k) Maximum Current Density. (mA/cm²)<br>@ 500 Ω | 3.87 mA/cm² | Not publicly available |
| l) Maximum Power Density, (W/cm²) @<br>500 Ω<br>(using smallest electrode conductive<br>surface area) 15.18 cm² | 0.11 W/cm² | 0.038 W/cm² |
| m) Burst Mode (i.e., pulse trains) | N/A | Not publicly available |
| a. Pulses per burst | | |
| b. Bursts per second | | |
| c. Burst duration (seconds) | | |
| d. Duty Cycle<br>[Line (b) x Line (c)] | | |
| n) ON Time (seconds) | N/A | Not publicly available |
| o) OFF Time (seconds) | N/A | Not publicly available |
| p) Additional features (if applicable) | N/A | N/A |
| Trade Name > | StimaWELL 120MTRS | Neurodyn II |
| a) Waveform<br>(e.g., pulsed monophasic, biphasic) | Biphasic | Not publicly available |
| b) Shape<br>(e.g., rectangular, spike, rectified<br>sinusoidal) | Rectangular | Not publicly available |
| c) Maximum Output Voltage<br>(specify units) | | Not publicly available |
| @ 500 Ω, | 62.7 Vpp<br>(+/- 10 %) | Not publicly available |
| @ 2 kΩ | 67.1 Vpp<br>(+/- 10 %) | Not publicly available |
| @ 10 kΩ | 68.7 Vpp<br>(+/- 10 %) | Not publicly available |
| d) Maximum Output Current<br>(specify units) | | 0 to 120mA peak to peak |
| @ 500 Ω, | 62.7 mAp<br>(+/- 10 %) | 124mA<br>Tolerance not publicly<br>available |
| @ 2 kΩ | 16.8 mAp<br>(+/- 10 %) | 110mA<br>Tolerance not publicly<br>available |
| @ 10 kΩ | 3.44 mAp<br>(+/- 10 %) | 39.2mA<br>Tolerance not publicly<br>available |
| e) Pulse Width (specify units) | 500 ms to 5 ms | Not publicly available |
| f) Frequency (Hz) | 1 Hz to 100 Hz | 0.5 Hz to 250 Hz |
| g) For interferential modes only:<br>Beat Frequency (Hz) | N / A | Not publicly available |
| h) For multiphasic waveforms only: | N / A<br>(Biphasic is noted<br>above) | Not publicly available |
| Phase<br>Symmetrical phases? (yes/no),<br>Phase Duration (include units)<br>(state range, if applicable) (both phases,<br>if asymmetrical) | | |
| i) Net Charge (μC per pulse) @ 500 Ω<br>(If zero, state method of achieving zero<br>net charge.) | N / A | Not publicly available |
| j) Maximum Phase Charge, (μC) @ 500 Ω | N / A | Not publicly available |
| k) Maximum Current Density, (mA/cm²)<br>@ 500 Ω | 4.13 mA/cm² | Not publicly available |
| l) Maximum Power Density, (W/cm²) @<br>500 Ω<br>(using smallest electrode conductive<br>surface area) | 0.13 W/cm² | 0.038 W/cm² |
| m) Burst Mode (i.e., pulse trains) | N/A | Not publicly available |
| a. Pulses per burst | | |
| b. Bursts per second | | |
| c. Burst duration (seconds) | | |
| d. Duty Cycle<br>[Line (b) x Line (c)] | | |
| n) ON Time (seconds) | N/A | Not publicly available |
| o) OFF Time (seconds) | N/A | Not publicly available |
| p) Additional features (if applicable) | | |

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### Table 5-3 Russian Mode

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#### Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the StimaWell 120MTR and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Pierenkemper completed a number of non-clinical performance tests against applicable standards.

| Test | Pass / fail criteria | Results | |
|------|----------------------------------|--------------------------------------------------------------------------|--------|
| 1 | Electrical safety | Compliance to IEC 60601-1:2005/AMD1:2012 | Passed |
| 2 | Electromagnetic<br>compatibility | Compliance to IEC 60601-1-2:2014 | Passed |
| 3 | Nerve and muscle<br>stimulators | Compliance to IEC 60601-2-10:2012 | Passed |
| 4 | Biocompatibility | Compliance to ISO 10993-1, ISO 10993-5:2009, and<br>ISO 10993-10:2002 | Passed |
| 5 | Risk Management | Compliance to ISO 14971:2007 | Passed |
| 6 | Software | Compliance to IEC 62304:2006 | Passed |
| 7 | Usability | Compliance to IEC 62366:2007 (Ed. 1) + A1: 2014<br>and EN 60601-1-6:2013 | Passed |

Table 5-2 – Performance Standards Testing Summary

The StimaWELL 120MTRS passed all the testing in accordance with internal requirements, national standards, and international standards shown above, to support substantial equivalence of the subject device.

To demonstrate that the StimaWELL 120MTRS meets all design specifications and performance requirements, nonclinical bench testing was performed in accordance with the internal development

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process in compliance with the recommendations of the FDA Guidance Document for Powered Muscle Stimulator 510(k)s [1999].

Also, internal verification and validation testing confirms that product specifications are met. The testing results support that the requirements for performance and electrical safety were met for the acceptance of the device. The StimaWELL 120MTRS passed all testing and supports the claims of substantial equivalence to the predicate device.

#### 10.Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics but can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The StimaWELL 120MTRS as designed and manufactured, is determined to be substantially equivalent to the predicate device.