(783 days)
No
The description focuses on standard electro-therapy and heating functionalities with user interaction via touchscreen and remote control. There is no mention of AI/ML terms, image processing, or data-driven learning processes.
Yes
The device is used for pain relief therapy and muscle stimulation for therapeutic purposes, such as symptomatic relief of pain, relaxation of muscle spasms, and prevention of disuse atrophy.
No
This device is described for therapeutic use (pain relief, muscle stimulation, relaxation of muscle spasms, prevention of disuse atrophy), not for diagnosing medical conditions.
No
The device description explicitly states it consists of hardware components including a Stimulation Mat, Controller, and Remote Control Unit, and mentions resistive heating for warming, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for pain relief and muscle stimulation/relaxation. These are therapeutic applications performed directly on the patient's body.
- Device Description: The device is described as an electro-therapy device with electrodes applied to the back region. It provides electrical stimulation and warming.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / 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
Product codes
GZJ, IPF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back area, lumbar paraspinal muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: Electrical safety, Pass / fail criteria: Compliance to IEC 60601-1:2005/AMD1:2012, Results: Passed
Test: Electromagnetic compatibility, Pass / fail criteria: Compliance to IEC 60601-1-2:2014, Results: Passed
Test: Nerve and muscle stimulators, Pass / fail criteria: Compliance to IEC 60601-2-10:2012, Results: Passed
Test: Biocompatibility, Pass / fail criteria: Compliance to ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2002, Results: Passed
Test: Risk Management, Pass / fail criteria: Compliance to ISO 14971:2007, Results: Passed
Test: Software, Pass / fail criteria: Compliance to IEC 62304:2006, Results: Passed
Test: Usability, Pass / fail criteria: Compliance to IEC 62366:2007 (Ed. 1) + A1: 2014 and EN 60601-1-6:2013, Results: Passed
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
StimaWELL 120MTRS
K181645
1. Submission Sponsor
Pierenkemper GmbH Am Geiersberg 6 35630 Ehringshausen Germany
Phone: (+49) 6443 8333-574 Fax: (+49) 6444 8333-580 Contact: Thorsten Reichel Title: Technical Director
2. Submission Correspondent
Emergo Global Consulting 2500 Bee Cave Rd, Suite 300 Austin, TX 78746 Cell Phone: +41 78 843 7077 Office Phone: (512) 327 9997
Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, RA/QA Email: LST.AUS.ProjectManagement@ul.com.
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 |
| Powered muscle stimulator | |
| Regulation Number | 882.5890 |
| 890.5850 | |
| Product Codes | GZJ |
| IPF | |
| Regulation Name | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Stimulator, Muscle,Powered |
4
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.
5
| Manufacturer | Pierenkemper GmbH | IBRAMED EQUIPAMENTOS MEDICOS |
|---|---|---|
| Trade Name | StimaWELL 120MTRS | Neurodyn II |
| 510(k) Number | K181645 | K131917 |
| Product Code | GZJ | |
| IPF | GZJ | |
| IPF | ||
| GZI | ||
| Regulation Number | 882.5890 | |
| 890.5850 | 882.5890 | |
| 890.5850 | ||
| 882.5810 | ||
| Regulation Name | Transcutaneous electrical nerve | |
| stimulator for pain relief | Transcutaneous electrical nerve | |
| stimulator for pain relief | ||
| Powered muscle stimulator | Powered muscle stimulator | |
| External functional neuromuscular | ||
| stimulator | ||
| Indications for Use | N/A | |
| The StimaWELL is not used as a FES | ||
| device | ||
| TENS mode: |
- Symptomatic relief of chronic (long
term) intractable pain - Symptomatic relief of post-traumatic
acute pain and post surgical pain | | As a TENS device: - Symptomatic relief of chronic (long
term) intractable pain - Symptomatic relief of post-traumatic
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 | | As a Burst Modulated Alternating
Current
(Russian) device: - Temporary relaxation of muscle
spasms - Prevention or retardation of disuse
atrophy in post-injury type conditions - Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of
motion |
| Technological
characteristic | Medium-frequency
alternating current (MFAC);
modulated low-frequency alternating
current | Medium-frequency
alternating current (MFAC);
Low-frequency alternating current
(LFAC) |
Table 5-1 – Comparison of Characteristics
6
| Electro-therapy
| Mechanism of Action | Transcutaneous muscle stimulation | Transcutaneous muscle stimulation |
|---|---|---|
| Operating Modes: | ||
| TENS | ||
| Russian | ||
| FES | Yes | |
| Yes | ||
| No | Yes | |
| Yes | ||
| 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 | ||
| Software Micro- | ||
| processor | Yes | Yes |
| Method of line | ||
| current isolation | Double Isolation | Double Isolation |
| Patient leakage | ||
| control-normal | ||
| condition | StimaWELL 120MTRS | |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------- | ----------------------------------------------- |
| a) Waveform | ||
| (e.g., pulsed monophasic, biphasic) | biphasic | Not publicly available |
| b) Shape | ||
| (e.g., rectangular, spike, rectified | ||
| sinusoidal) | rectangular | Not publicly available |
| c) Maximum Output Voltage | ||
| (specify units) | Not publicly available | |
| @ 500 Ω, | 58.7 Vpp | |
| (+/- 10 %) | Not publicly available | |
| @ 2 kΩ | 57.6 Vpp | |
| (+/- 10 %) | Not publicly available | |
| @ 10 kΩ | 68.3 Vpp | |
| (+/- 10 %) | Not publicly available | |
| d) Maximum Output Current | ||
| (specify units) | 0 to 120mA peak to peak | |
| @ 500 Ω, | 58.7 mA | |
| (+/- 10 %) | 124mA | |
| Tolerance not publicly available | ||
| @ 2 kΩ | 14.4 mA | |
| (+/- 10 %) | 110mA | |
| Tolerance not publicly available | ||
| @ 10 KΩ | 3.42 mA | |
| (+/- 10 %) | 39.2mA | |
| 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: | ||
| Beat Frequency (Hz) | N / A | Not publicly available |
| h) For multiphasic waveforms only: | ||
| Phase | ||
| Symmetrical phases? (yes/no), | ||
| Phase Duration (include units) | ||
| (state range, if applicable) (both phases, | ||
| if asymmetrical) | N / A (Biphasic is | |
| noted above) | Not publicly available | |
| i) Net Charge (μC per pulse) @ 500 Ω | ||
| (If zero, state method of achieving zero | ||
| 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) | ||
| @ 500 Ω | 3.87 mA/cm² | Not publicly available |
| l) Maximum Power Density, (W/cm²) @ | ||
| 500 Ω | ||
| (using smallest electrode conductive | ||
| 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 | ||
| [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 | ||
| (e.g., pulsed monophasic, biphasic) | Biphasic | Not publicly available |
| b) Shape | ||
| (e.g., rectangular, spike, rectified | ||
| sinusoidal) | Rectangular | Not publicly available |
| c) Maximum Output Voltage | ||
| (specify units) | Not publicly available | |
| @ 500 Ω, | 62.7 Vpp | |
| (+/- 10 %) | Not publicly available | |
| @ 2 kΩ | 67.1 Vpp | |
| (+/- 10 %) | Not publicly available | |
| @ 10 kΩ | 68.7 Vpp | |
| (+/- 10 %) | Not publicly available | |
| d) Maximum Output Current | ||
| (specify units) | 0 to 120mA peak to peak | |
| @ 500 Ω, | 62.7 mAp | |
| (+/- 10 %) | 124mA | |
| Tolerance not publicly | ||
| available | ||
| @ 2 kΩ | 16.8 mAp | |
| (+/- 10 %) | 110mA | |
| Tolerance not publicly | ||
| available | ||
| @ 10 kΩ | 3.44 mAp | |
| (+/- 10 %) | 39.2mA | |
| 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 250 Hz |
| g) For interferential modes only: | ||
| Beat Frequency (Hz) | N / A | Not publicly available |
| h) For multiphasic waveforms only: | N / A | |
| (Biphasic is noted | ||
| above) | Not publicly available | |
| Phase | ||
| Symmetrical phases? (yes/no), | ||
| Phase Duration (include units) | ||
| (state range, if applicable) (both phases, | ||
| if asymmetrical) | ||
| i) Net Charge (μC per pulse) @ 500 Ω | ||
| (If zero, state method of achieving zero | ||
| 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) | ||
| @ 500 Ω | 4.13 mA/cm² | Not publicly available |
| l) Maximum Power Density, (W/cm²) @ | ||
| 500 Ω | ||
| (using smallest electrode conductive | ||
| 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 | ||
| [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) |
8
9
Table 5-3 Russian Mode
10
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 | ||
| compatibility | Compliance to IEC 60601-1-2:2014 | Passed | |
| 3 | Nerve and muscle | ||
| stimulators | Compliance to IEC 60601-2-10:2012 | Passed | |
| 4 | Biocompatibility | Compliance to ISO 10993-1, ISO 10993-5:2009, and | |
| 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 | |
| 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
11
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.