(217 days)
To identify the Reference Device(s) K/DEN number, I need to look for the "Reference Device(s)" section in the provided text.
In your input, the "Reference Device(s)" section explicitly states:
Reference Device(s)
Not Found
Therefore, there are no Reference Device(s) K/DEN numbers listed.
No
The document describes a standard TENS device with a microprocessor for controlling modes and strength. There is no mention of AI, ML, or any learning or adaptive capabilities based on data. The performance studies are focused on safety and compatibility, not algorithmic performance.
Yes.
The device is marketed for the temporary relief and management of pain associated with sore muscles and arthritis, which are therapeutic claims.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary relief and management of pain. It is not described as diagnosing any condition, but rather providing symptomatic relief.
No
The device description explicitly states it consists of hardware components including a microprocessor, buttons, electrical pads, and display, in addition to software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief and management of pain by applying electrical stimulation to the body. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a TENS device that delivers electrical pulses to the body through electrodes. This is consistent with a therapeutic device, not a device that analyzes samples from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the AD-2129A TENS device is a therapeutic device used for pain relief, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes
NUH, NYN
Device Description
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.
The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time
Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use (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
Non-clinical Testing Summary:
(1) Biocompatibility of materials: Tested according to ISO 10993-5 and ISO 10993-10, result shows it meets applicable requirements.
(2) Electromagnetic Compatibility: Tested according to IEC 60601-1-2, result shows it meets all applicable requirements.
(3) Electrical Safety Testing: Tested according to IEC 60601-1 and IEC 60601-2-10, result shows it meets all applicable requirements.
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Andon Health Co., Ltd. Liu Yi President No. 3, Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190
Re: K150043
Trade/Device Name: AD-2129A Transcutaneous Electrical Nerve Stimulators (TENS) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: July 14, 2015 Received: July 16, 2015
Dear Liu Yi:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Michael J. Hoffmann -S
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) K150043
Device Name
AD-2129A Transcutaneous Electrical Nerve Stimulators (TENS)
Indications for Use (Describe)
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 1/7/2015 |
2.0 Device name
Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Device name: Transcutaneous Electrical Nerve Stimulators (TENS) Model: AD-2129A
3.0 Classification
Production code: NUH, NYN Regulation number: 21 CFR 882.5890 Classification: II Panel: Neurology
4.0 Predicate device information
| Information | Predicate 1 | Predicate 2 |
|---|---|---|
| 510(k) number: | K131159 | K140168 |
| Manufacturer | Chattem, Inc. | EasyMed Instruments |
4
| Co., Ltd. | ||
|---|---|---|
| Trade/Proprietary Name | Smart Relief | EasyStim TN28_OTC |
| Classification Name | Transcutaneous Nerve | |
| Stimulator. | Transcutaneous Nerve | |
| Stimulator. | ||
| Regulation number | 882.5890 | 21 CFR 882.5890 |
| Classification | Class II | Class II |
| Product Code | NUH, NYN | NUH |
5.0 Intended use
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities, It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
6.0 Device description
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.
The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time
Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
7.0 Performance summary
TENS conforms to the following standards:
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- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005.
- · IEC 60601-2-10, Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- · ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.
- · ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization.
8.0 Non-clinical Testing Summary
The following testing was performed on the TENS devices in accordance with the requirements of the design control regulations and established quality assurance procedures.
(1) Biocompatibility of materials
When use the TENS device, one side of the electrode will contact the user, and the materials used on this side is tested according to ISO 10993-5 and ISO 10993-10, and the result shows it meet the applicable requirements.
(2) Electromagnetic Compatibility
Electromagnetic Compatibility test has been performed on the TENS devices according to the identical standard of IEC 60601-1-2, and the test result show that, the device meet all the applicable requirements.
(3) Electrical Safety Testing
Electrical Safety Test has been performed according to IEC 60601-1, and the test result shows that, the device meet all the applicable requirements. Also,
6
particular safety test has been performed according to IEC 60601-2-10.
9.0 Comparison to the predicate device and the conclusion
The applicant device TENS is substantially equivalent to Smart Relief (K131159) and EasyStim TN28_OTC(K140168).
| Similarities and differences comparison | |||
|---|---|---|---|
| Characteristics | Subject device | Predicate device(1) | Predicate device(2) |
| Product name | AD-2129A TENS device | Smart Relief | EasyStim TN28_OTC |
| 510(K)number | To be assigned | K131159 | K140168 |
| Product code | NUH, NYN | NUH, NYN | NUH |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Intended use | The device is intended | ||
| for temporary relief of pain | |||
| associated with sore and | |||
| aching muscles due to | |||
| strain from exercise or | |||
| normal household and | |||
| work activities, It is also | |||
| intended for symptomatic | |||
| relief and management of | |||
| chronic, intractable pain | |||
| and relief of pain | |||
| associated with arthritis. | To be used for temporary | ||
| relief of pain associated with | |||
| sore and aching muscles | |||
| due to strain from exercise | |||
| or normal household and | |||
| work activities. | |||
| To be used for symptomatic | |||
| relief and management of | |||
| chronic, intractable pain and | |||
| relief of pain associated with | |||
| arthritis. | This device is intended for | ||
| the relief of pain associated | |||
| with sore or aching muscles | |||
| of the lower back, arms, or | |||
| legs due to strain from | |||
| exercise or normal | |||
| household and work | |||
| activities. | |||
| Presentation or | |||
| OTC | OTC | OTC | OTC |
| Environment of | |||
| use | Home use | Not specified | Clinics, hospital and home |
| environments | |||
| Number of | |||
| Outputs mode | 8 | 1 | 8 |
| Number of | |||
| Outputs | 2 | 1 | 2 |
| Waveform | Monophasic rectangular | Asymmetrical Biphasic | |
| rectangular | Biphasic rectangular | ||
| Monophasic rectangular | |||
| Maximum | |||
| output | |||
| voltage(max) | |||
| 500 Ω, 2 kΩ, | |||
| and 10 kΩ | 500 Ω: 48V | ||
| 2 kΩ: 91.2V | |||
| 10 kΩ: 46V | Not specified | 500 Ω: 68V | |
| 2 kΩ: 102V | |||
| 10 kΩ: 110V | |||
| Maximum | 500 Ω: 96mA | 500 Ω: 133mA | |
| Output | |||
| Current 500 Ω, | |||
| 2 kΩ, and 10 | |||
| kΩ | 2KΩ: 4.33mA | ||
| 10 kΩ:0.44 mA | Not specified | 2KΩ: 51mA | |
| 10 kΩ:11 mA | |||
| Maximum | |||
| Phase Charge, | |||
| (μC) @ 500 Ω | 11.92uC | Not specified | 20.02uC |
| Maximum | |||
| Average | |||
| Current(500ohm) | 8.64mA | Not specified | 3.0375mA |
| Maximum | |||
| Current Density, | |||
| (mA/cm² @ 500 Ω) | 0.38mA/cm² | Not specified | 0.188mA/cm² |
| Maximum | |||
| Average Power | |||
| Density, (W/cm² | |||
| @ 500 Ω | 1.62mW/cm² | Not specified | 7.52mW/cm² |
| Frequency | |||
| (Hz) | 2-125HZ | 1-100 Hz | 1-150Hz |
| Pulse | |||
| Duration(us) | 60-125 | Not specified | 10-250us, in steps of 50us |
| Burst Mode | None | None | Yes |
| Timer | |||
| range(min) | 15 minutes for all | ||
| programs | Not specified | 20min, 25min, 30min, 40min | |
| depending on preset | |||
| program | |||
| Indication | |||
| display: | -On/Off status | ||
| -Output strength | |||
| -Output mode | |||
| -Time to cut-off | Not specified | -On/Off status | |
| -Low battery | |||
| -Voltage/Current level | |||
| -Output mode | |||
| -Time to cut-off | |||
| Power Source | 4×1.5 size AAA | 3 V lithium battery | 2 Alkaline AA 1.5V (LR6) |
| Batteries | |||
| Dimension | 140mm×63mm×30mm | 64mmX38mmX13mm | 66mm×136mm×30.7mm |
| Weight | 88g (exclude battery) | 20g | 146.5 grams |
| Housing | |||
| Materials | ABS | ABS | ABS |
| Microprocessor | |||
| control | Yes | Yes | Yes |
| Automatic | |||
| Overload trip | No | Not specified | Yes |
| Automatic | |||
| no-load trip | Yes | Not specified | Yes |
| Automatic | |||
| shut-off | Yes | Not specified | Yes |
| User override | |||
| control | No | Not specified | Yes |
| Electrode | |||
| compliance | |||
| with 21 CFR | |||
| 898 | Yes | Yes | Yes |
| Electrode cable | Yes | No | Yes |
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The new device AD-2129A TENS has the same intended use, design, technological characteristics as the predicate device K131159 and K140168. Only pulse frequency, pulse strength and the appearance are different, but the Electrical Safety test and the EMC test in this submission provides demonstrated that these small differences do not raise any new questions of safety and effectiveness to the new devices.