(30 days)
No
The description details a standard TENS device with fixed modes and adjustable intensity, with no mention of AI or ML capabilities.
Yes
The device is intended for temporary relief of pain associated with sore and aching muscles, which qualifies it as a therapeutic device.
No
The device description and intended use state that the device is a transcutaneous electrical nerve stimulator (TENS) used for pain relief by applying an electrical current. It does not mention diagnosis or any function related to identifying or characterizing a medical condition.
No
The device description explicitly states it consists of a "stimulus generator" and "electrode," which are hardware components. It is a physical TENS device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary relief of pain associated with sore and aching muscles...". This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The device description explains how it works by applying electrical current to the skin for pain relief. This is a physical intervention, not a test performed on biological samples.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). There is no mention of this device interacting with or analyzing any biological samples.
Therefore, the Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back as well as upper and lower extremities (arm and/or leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data is not required to determine the safety and performance of the device. The subject device is identical to the predicate device with regards to intended use, technological characteristics, manufacturing, and labeling (apart from the different tradename). Therefore, descriptive information alone is sufficient to address the substantial equivalence determination.
Clinical tests were not conducted for the Balego TENS device because there were no changes to the indications for use or technological characteristics as compared to the predicate device that would warrant clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.
June 6, 2018 Everyway Medical Instruments CO., LDT. % Aaron Hage Associate Attorney DuVal & Associates 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402
Re: K181207
Trade/Device Name: Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: May 4, 2018 Received: May 7, 2018
Dear Aaron Hage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
William J. Heetderks -S 2018.06.06 16:37:48 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181207
Device Name
Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC)
Indications for Use (Describe)
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
| 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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Image /page/3/Picture/0 description: The image shows the word "EVERYWAY" in a teal color, sandwiched between horizontal teal lines. There are three lines above the word and three lines below the word. The lines and the word are all the same color.
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Beishen Rd. Shenkeng Dist., New Taipei City, 22203, Taiwan
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K181207.
-
- Submitter's Identifications:
| Establishment: | Everyway Medical Instrument CO., LTD. |
|---|---|
| Address: | 3 FL., NO. 5, Lane 155, Section 3, Beishen Rd. |
| Shenkeng Dist., New Taipei City, 22203, Taiwan | |
| Registration Number: | 9616877 |
| Operations Manufacturer | |
| Owner/Operator: | Everyway Medical Instrument CO., LTD. |
| Contact Person: | Robert Tu |
| Phone: | 886-2-2662-0038 |
| Fax No: | 886-2-2664-5566 |
| e-mail: | robert@everyway-medical.com |
2. Date 510(k) Summary Prepared: April 25, 2018
3. Name of the Subject Device and Classification Information:
| Tradename/Device
Name | Balego™ TENS Digital Edition with Accessories for Pain
Relief (OTC) |
|--------------------------|------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 882.5890 |
| Classification Name | Transcutaneous electrical nerve stimulator for pain relief. |
| Regulatory Class | Class II |
| Product Code | NUH |
-
- Information of the 510(k) Cleared Device (Predicate Device):
| Tradename/Device | EV-804 OTC Pain Relief TENS |
|---|---|
| Name | |
| 510(k) Number | K172919 |
| Regulation Number | 21 CFR 882.5890 |
| Classification Name | Transcutaneous electrical nerve stimulator for pain relief. |
| Regulatory Class | Class II |
| Product Code | NUH |
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5. Device Description:
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
6. Indications for Use:
The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
5
7. Comparison to the 510(k) Cleared Device (Predicate Device):
| Features | Predicate Model | Proposed Model |
|---|---|---|
| Model | EV-804 | BAL-820 |
| 510(K) No. | K172919 | K18XXXX |
| Prescription or OTC | OTC | OTC |
| Indication for use | The OTC Pain Relief TENS, model EV-804, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. | The Balego™ TENS Digital Edition, model BAL-820, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. |
| FDA product code | NUH | NUH |
| Accessory | Self Adhesive Electrode | |
| (5x5 cm)/K083302 | Self Adhesive Electrode | |
| (5x5 cm)/K083302 |
Table S-1. Overview of the predicate and proposed device model
Table S-2. Comparison of significant output characteristics.
| Comparison feature | Predicate Model | New Model |
|---|---|---|
| EV-804 | Balego TENS | |
| Net charge | 0 | 0 |
| Max. phase charge | 20.8 uc | 20.8 uc |
| Max. current Density | 0.0998 mA/cm2 | 0.0998 mA/cm2 |
| Max. Average | ||
| current | ||
| (RMSA) | 500Ω | 80 mA |
| 2KΩ | 40 mA | |
| 10KΩ | 10 mA | |
| Max. Power Density | 0.00399 Watts/ cm2 | 0.00399 Watts/ cm2 |
| Burst Mode | Yes | Yes |
Table S-3. Comparison of output specifications.
| Predicate Device | New Device | ||
|---|---|---|---|
| Mode or Program Name | EV-804 | Balego TENS | |
| 510(K) Number | K172919 | K18XXXX | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic asymmetric | Biphasic asymmetric | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | |
| Maximum Output Voltage | |||
| (volts) (+/- 20 %) | 40V @500Ω | ||
| 80V @2KΩ | |||
| 100V @10KΩ | 40V @500Ω | ||
| 80V @2KΩ | |||
| 100V @10KΩ | |||
| Maximum Output Current | |||
| (mA) (+/- 20 %) | 80mA @500Ω | ||
| 40mA @2KΩ | |||
| 10mA | |||
| @10KΩ | 80mA @500Ω | ||
| 40mA @2KΩ | |||
| 10mA | |||
| @10KΩ | |||
| Duration of primary phase (usec) | 260 max | 260 max | |
| Pulse Duration (usec) | 8333 max | 8333 max | |
| Frequency (Hz) [or Rate (pps)] | 120 max | 120 max | |
| For | |||
| multiphasic | |||
| waveforms | |||
| only: | Yes | Yes | Yes |
| Not applicable | Not applicable | Not applicable |
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| Predicate Device | New Device | ||
|---|---|---|---|
| Power Source(s) | 9V x 1 | ||
| (6F22 | |||
| Size) | 9V x 1 | ||
| (6F22 | |||
| Size) | |||
| Type BF | Type BF | ||
| - Method of Line current Isolation | --- | --- | |
| - Patient Leakage Current | --- | --- | |
| - Normal condition (uA) | Under 0.1 | Under 0.1 | |
| - single Fault condition (uA) | Under 0.5 | Under 0.5 | |
| Average DC current through electrodes when | |||
| device is on but no pulses are being applied | |||
| (uA) | Not applicable | Not applicable | |
| Number of Output Modes | 8 | 8 | |
| Number of Output | Synchronous | Synchronous | Synchronous |
| Channels: | Output | ||
| Coil | Transformer | Transformer | |
| Regulated Current or Regulated Voltage? | Current | Current | |
| Software/Firmware/Microprocessor control? | Yes | Yes | |
| Automatic Overload Trip? | No | No | |
| Automatic No-Load Trip? | Yes | Yes | |
| Automatic Shut Off? | Yes | Yes | |
| User Override control? | No | No | |
| Yes | Yes | Yes | |
| Indicator Display: | Yes | Yes | Yes |
| Yes | Yes | Yes | |
| Timer Range (Minutes) | 15, 30,60 and | ||
| Continuous | 15, 30,60 and | ||
| Continuous | |||
| Compliance with Voluntary Standards? | |||
| Compliance with 21 CFR 898? | Yes | Yes | |
| Weight (g) including battery | 155 | 155 | |
| Dimensions (mm.) [W x H x D] | 101×68×21.5 | 101×68×21.5 | |
| Housing Materials and construction | ABS | ABS | |
| Pulse per burst | 6 | 6 | |
| Burst per second | 2 | 2 | |
| Bust duration | 260us | 260us | |
| Duty Cycle | Same for each | ||
| program | Same for each | ||
| program | |||
| Method of achieving zero net charge for net | |||
| charge/pulse | wave for each pulse | wave for each pulse |
8. Non-Clinical Tests Performed to Determine the Safety and Performance of the Device:
Non-clinical performance data is not required to determine the safety and performance of the device. The subject device is identical to the predicate device with regards to intended use, technological characteristics, manufacturing, and labeling (apart from the different tradename). Therefore, descriptive information alone is sufficient to address the substantial equivalence determination.
7
-
- Clinical Test Validation Activities Performed to Determine the Effectiveness of Device:
Clinical tests were not conducted for the Balego TENS device because there were no changes to the indications for use or technological characteristics as compared to the predicate device that would warrant clinical testing.
- Clinical Test Validation Activities Performed to Determine the Effectiveness of Device:
10. Summary for the technology comparison.
As evidence by The Balego™ TENS device has the same technological characteristics as the predicate device regarding product design, material, and energy source type, and all other technological features.
11. Conclusions
The Balego TENS device is the identical device to the predicate device, apart from its tradename. The Balego TENS device has the same intended use and the same technological characteristics as the legally marketed predicate device. Therefore, the Balego TENS device is substantially equivalent to the predicate device.