(259 days)
No
The description focuses on pre-set modes, user control of output, and standard electrical stimulation technology without mentioning any adaptive algorithms, learning capabilities, or AI/ML terminology.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) device used for the temporary relief of pain associated with sore and aching muscles, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) device used for pain relief, not for diagnosing medical conditions. Its function is to apply electrical pulses to alleviate pain, not to detect or identify diseases or conditions.
No
The device description explicitly states it is an "electrically powered device" and a "handheld, AA battery-operated portable device," indicating it is a hardware device that delivers electrical pulses.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device applies electrical pulses to the skin to relieve pain. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples
- Detecting biomarkers
- Providing diagnostic information
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any of those functions. It is a therapeutic device.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes.
The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the mode and power setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user / home or clinic
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)
Nonclinical tests:
Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices.
The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005.
The candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2017
Avazzia, Inc. Tammy Lahutsky Regulatory Affairs 13140 Coit Road Suite 515 Dallas, Texas 75240 (214) 575-2820 [voice] (214) 575-2824 [fax] tlahutsky@avazzia.com
Re: K162392
Trade/Device Name: Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia BlueTM, Avazzia Star™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 12, 2017 Received: April 14, 2017
Dear Tammy Lahutsky:
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "William J. Heetderks" in a large, bold font. To the right of the name is a digital signature block, which includes information such as the signer's name, date, and organizational details. The signature indicates that the document was digitally signed by William J. Heetderks on May 12, 2017. The signature block also contains details about the signer's organizational affiliations, including U.S. Government, HHS, and FDA.
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) K162392
Device Name
Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia Blue™, Avazzia Star™
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Type of Use (Select one or both, as applicable)
| Regulation Use (Part 21 CFR 601 Subpart E) | ☑ Same Tissue Convention (21 CFR 601 Subpart C) |
|---|---|
| -------------------------------------------- | ------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Submitter's Identifications:
Manufacturer and Sponsor:
Avazzia, Inc. 13140 Coit Road., Suite 515 Dallas, TX 75240 USA Tel. 214-575-2820 Establishment Registration # 3004839404 Official Contact Person: Tammy Lahutsky Date of Summary Preparation: August 18, 2016
Trade Names of Candidate Devices:
Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia Blue™, Avazzia Star™
Classifications: TENS, Class II 21 CFR 882.5890 NUH
Information of the 510(k) Cleared Devices (Predicate Devices):
Primary Predicate:
Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744 03/28/2013, TENS Class II 21 CFR 882.5890 NUH, NGX
Reference Devices:
Avazzia TENS Model BEST-AV1™, K062641, 4/30/2007, TENS, Class II 21 CFR 882.5890 GZJ Avazzia TENS Model Best-AV2™, K123099, 05/23/2014, TENS, Class II, 21 CFR 882.5890, GZJ Gemore Technology Co. LTd. Low back pain relief system, models model GM310PP, GM320PP, GM321PP, K060222, 04/28/2006, TENS Class II 21 CFR 882.5890 NUH
Intended Use:
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Description of Candidate Devices:
Description of Candidate Devices as might be found in the labeling or promotional material:
Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes.
Description of the Candidate Devices - How the devices work:
The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
4
The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the mode and power setting.
Scientific Concepts that form the basis of the devices:
Various modes in the candidate device are suited for TENS applications.
Design Description: Significant physical and performance characteristics of the device including stimulation output specifications & Summary of the Technological Characteristics Compared to the Predicates are shown below:
Discussion of any different technological characteristics between the devices and the predicate devices:
The candidate devices have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device as summarized in the technological characteristics.
Accessories
Self-adhesive conductive electrode pads Soft tissue electrodes with common name: Y electrodes Lead wires
Nonclinical tests
Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices.
The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005.
The candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2.
Safety and effectiveness
The Avazia device technological specifications are the same; therefore, they do not pose new questions regarding safety and effectiveness.
Indications for use for TENS OTC has been established, therefore, indications for use do not pose new questions regarding safety and effectiveness.
Basis for a determination of substantial equivalence:
- Do the candidate Devices have the same indications for use? Yes
- Do the candidate Devices have the same Technological Characteristics? Yes
5
- . Do the candidate devices pose any new questions regarding safety of effectiveness? No
- . Do the candidate devices have accepted scientific methods for evaluating safety and effectiveness? Yes
- . Do the candidate devices demonstrate no diminishment of performance? Yes
Conclusions:
The Avazzia OTC TENS Model BEST – AV1™ devices have intended uses and technological characteristics that are substantially equivalent to predicate devices.
| Summary of Technical Characteristics | ||||||
|---|---|---|---|---|---|---|
| Candidates | Predicate | |||||
| Device Name and Model | BEST-AV1, Med-Best, Med- | |||||
| Sport, Avazzia Blue, | ||||||
| Avazzia Star | Models PL009, PL009A, | |||||
| and PL029 | ||||||
| Manufacturer | Avazzia, Inc. | Propera | ||||
| Power Source | Two 1.5 V AA batteries | Four 1.5 V AAA batteries | ||||
| Method of Line Current Isolation | Battery Supply N/A | Battery Supply N/A | ||||
| Patient Leakage Current | ||||||
| Normal Condition |
-
| ua | 13.7 | 1.8 | | | |
| Single Fault Condition
-
| ua | 27 | 3.3 | | | |
| Average DC current through | | | | | | |
| electrodes when device is on but no | ua | 0 | 0 | | | |
| pulses are being applied | | | | | | |
| Number of output modes | Number | 2, 4 | 3 | | | |
| Number of output channels: | | 1 | Synchronous | | | |
| Synchronous/Alternating?
-
| | n/a | ON/Off Switch or By | | | |
| Method of Channel Isolation
-
| | n/a | Software | | | |
| Regulated Current or Regulated
Voltage | | Voltage control | Voltage control | | | |
| Software control | | Yes | Yes | | | |
| Automatic Overload Trip? | | No | No | | | |
| Automatic No-Load Trip? | | Yes | No | | | |
| Automatic Shut Off? | | Yes | Yes | | | |
| User Override Control? | | Yes | Yes | | | |
| Indicator Display | | | | | | |
| On/Off Status?
-
| | Yes | Yes | | | |
| Low Battery?
-
| | Yes | No | | | |
| Voltage/Current intensity?
-
| | Yes | No | | | |
| Timer Range | Minutes | 60 | 5, 10, or 15 | | | |
| Compliance with Voluntary Standards? | | Yes | Yes | | | |
| Compliance with 21 CFR 898 | | Yes | Yes | | | |
| Weight | OZ | 7 | 8 | | | |
| Dimensions | In | 4.6 x 2.5 x 1.3
(117mm X 64mm X 33mm) | 2.2 x 7.8 x 0.9 | | | |
| Housing materials and construction | | Enclosure: ABS | Enclosure: ABS | | | |
| Wavform | | Biphasic | monophasic | | | |
| Shape | | positive square wave
followed by a damped
sinusodial waveform of
variable duration
depending on damping and
body loading | regular | | | |
6
| Summary of Technical Characteristics | |||
|---|---|---|---|
| Candidates | Predicate | ||
| Device Name and Model | BEST-AV1, Med-Best, Med- | ||
| Sport, Avazzia Blue, | |||
| Avazzia Star | Models PL009, PL009A, | ||
| and PL029 | |||
| Max output voltage (+/- 20%) | |||
| - at 500 Ω | V | -42 | 12.8 |
| - at 2,000 Ω | V | -122 | 51 |
| - at 10,000 Ω | V | -348 | 368 |
| - Max output current (+/- 20%) | |||
| - at 500 Ω | uA | 3080 | 15,000 |
| - at 2,000 Ω | uA | 451 | 3,200 |
| - at 10,000 Ω | uA | 535 | 600 |
| Duration of primary | |||
| (depolarizing phase) | µSec | 506 | 0.040 |
| Pulse Duration | uSec | 1100 | 120 to 6800 |
| Frequency | Hz | 20 to 185 | 1 to 100 |
| Net Charge per pulse at 500 Ω | uC | 4.0 | 18,000 |
| Max Charge per pulse at 500 Ω | uC | 10.12 | 23 |
| Max current density at 500 Ω | mA/cm2 | 1.6 | 1.4 |
| Max average power density at 500 Ω | mW/cm2 | 2.445 | 230 |
| Burst mode | |||
| (a) pulse per burst | Up to 8 | 1 | |
| (b) burst per second | Up to 77 | 0-25 | |
| (c) burst duration (sec) | Up to 6mSec | 1 | |
| (d) Duty Cycle | 46% | 5 | |
| On Time | Sec | 0.46 | Potentiometer switch |
| Off time | Sec | 0.54 | Potentiometer switch |
| Additional Features | N/A | N/A |