(90 days)
No
The description focuses on standard TENS technology with a microprocessor for controlling modes and strength, and there is no mention of AI or ML capabilities.
Yes
The intended use statement explicitly states that the device is for "temporary relief of pain" and "symptomatic relief and management of chronic, intractable pain," which are therapeutic purposes.
No
Explanation: The device is intended for pain relief and management, not for diagnosing a condition.
No
The device description explicitly lists hardware components such as a microprocessor, buttons, electrical pads, and a display.
Based on the provided information, the AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The AD-2126 TENS device is a therapeutic device that applies electrical stimulation to the body's surface for pain relief. It does not analyze any biological samples.
The description clearly states its intended use is for pain relief by applying electrical pulses through electrodes placed on the skin. This is a form of external physical therapy, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AD-2126 Transcutaneous Electrical Nerve Stimulators 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 associated with arthritis.
Product codes
NUH, NYN
Device Description
The AD-2126 Transcutaneous Electrical Nerve Stimulators (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.
Self-adhesive electrodes are used in this device, and they are designed with conductive adhesive interface between the patient's skin and the Electrical Stimulator which help electrical signals transferred from the TENS device to the body and complete its function. The electrodes to be used with the device have been cleared under submission number K130987 with the trade name of ValuTrode® Neurostimulation Electrodes; model number: 50X50.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
Home 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 Testing:
- Biocompatibility of materials: Materials used on the electrode side meant to contact the user were tested according to ISO 10993-5 and ISO 10993-10, and met applicable requirements.
- Electromagnetic Compatibility: Performed according to IEC 60601-1-2, and the device met all applicable requirements.
- Electrical Safety Testing: Performed according to AAMI ANSI ES60601-1 and IEC 60601-2-10, and the device met all applicable requirements.
- Software validation: Confirmed that changes in timer range and indication display do not impact safety and effectiveness.
Key results: The tests demonstrate that the subject device is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness despite differences in number of output modes, waveform, output specifications (maximum output voltage, maximum output current, maximum phase charge, maximum average current, maximum current density, maximum average power density, frequency, pulse duration), timer range, indication display, dimension, and weight.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2022
Andon Health Co., Ltd. Liu Yi President No. 3 Jinping Street, Ya An Road, Nankai District Tianiin 300190 P.R. China
Re: K222867
Trade/Device Name: AD-2126 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: September 22, 2022 Received: September 22, 2022
Dear Mr. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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).
Sincerelv.
Digitally signed by Robert M. Robert M. Stefani -S Date: 2022.12.21 Stefani -S 11:44:22 -05'00'
For Pamela Scott 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)
Device Name
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
Indications for Use (Describe)
The AD-2126 Transcutaneous Electrical Nerve Stimulators 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 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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3
510(K) SUMMARY
(In accordance with 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, 300190, P.R. China |
| Phone Number: | 86-22-87611660 |
| Fax Number: | 86-22-87612379 |
| Contact: | Mr. Liu Yi |
| Date of Preparation: | September 19, 2022 |
2.0 Device Information
| Device Name: | AD-2126 Transcutaneous Electrical Nerve Stimulators
(TENS) |
|----------------------|---------------------------------------------------------------|
| Classification Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
3.0 Classification
| Product Code: | NUH, NYN |
|---|---|
| Regulation Number: | 21 CFR 882.5890 |
| Classification: | II |
| Review Panel: | 882 Neurology |
4.0 Predicate Device Information
| Manufacturer: | Andon Health Co., Ltd. |
|---|---|
| Device: | AD-2126 Transcutaneous Electrical Nerve Stimulators |
| (TENS) | |
| 510(k) Number: | K150043 |
| Classification | II |
| Product Code | NUH, NYN |
5.0 Intended Use
The AD-2126 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.
4
6.0 Device Description
The AD-2126 Transcutaneous Electrical Nerve Stimulators (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.
Self-adhesive electrodes are used in this device, and they are designed with conductive adhesive interface between the patient's skin and the Electrical Stimulator which help electrical signals transferred from the TENS device to the body and complete its function. The electrodes to be used with the device have been cleared under submission number K130987 with the trade name of ValuTrode® Neurostimulation Electrodes; model number: 50X50.
7.0 Discussion of Non-Clinical Testing
TENS conforms to the following standards:
- AAMI ANSI ES60601-1:2005/(R)2012 And Al:2012, Cl:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10 Edition 2.1 2016-04, Medical electrical equipment Part 2-10: . Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- . IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- 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.
5
- ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation •
6
and skin sensitization.
None of the test demonstrate that the new device raises new questions of safety and effectiveness as compared to the predicate.
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 meets all the applicable requirements.
(3) Electrical Safety Testing
Electrical Safety Test has been performed according to AAMI ANSI ES60601-1, and the test result shows that, the device meets all the applicable requirements. Also, particular safety test has been performed according to IEC 60601-2-10.
9.0 Comparison to the Predicate Device and Conclusion
The conclusion drawn from the nonclinical tests demonstrate that the subject device AD-2126 Transcutaneous Electrical Nerve Stimulators is substantially equivalent to theAD-2129A Transcutaneous Electrical Nerve Stimulators (K150043).
| Characteristics | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Product name | AD-2126 TENS device | AD-2129A TENS device | |
| 510(K)number | To be assigned | K150043 | |
| Product code | NUH,NYN | NUH,NYN | Same |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 | Same |
| 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 | The device is intended | ||
| for | |||
| temporary relief of pain | |||
| associated with sore and aching | |||
| muscles due to strain from | |||
| exercise or normal household | Same | ||
| and work activities, It is also | |||
| intended for symptomatic relief | |||
| and management of chronic, | |||
| intractable pain and relief of | |||
| pain associated with arthritis. | and work activities, It is also | ||
| intended for symptomatic relief | |||
| and management of chronic, | |||
| intractable pain and relief of | |||
| pain associated with arthritis. | |||
| Presentation or | |||
| OTC | OTC | OTC | Same |
| Environment of | |||
| use | Home use | Home use | Same |
| Number of | |||
| Outputs mode | 24 | 8 | See 3.3 |
| Note 1 | |||
| Number of | |||
| Outputs | 2 | 2 | Same |
| Waveform | Biphasic rectangular | ||
| Monophasic rectangular | Asymmetrical Biphasic | ||
| rectangular | See 3.5 | ||
| Note2 | |||
| Maximum output | |||
| voltage(max) | |||
| $500\Omega$ , 2 k $\Omega$ , and | |||
| 10 k $\Omega$ | $500 \Omega$ : 60V | ||
| $2K \Omega$ :64.8V | |||
| $10K \Omega$ : 68.4V | $500 \Omega$ : 48V | ||
| $2K \Omega$ : 91.2V | |||
| $10 k \Omega$ : 46V | See 3.6 | ||
| Note 3 | |||
| Maximum | |||
| OutputCurrent | |||
| $500\Omega$ , 2 k $\Omega$ , and | |||
| 10 k $\Omega$ | $500\Omega$ : 120mA | ||
| $2K \Omega$ : 32.4mA | |||
| $10K \Omega$ : 6.84mA | $500 \Omega$ : 96mA | ||
| $2K \Omega$ : 4.33mA | |||
| $10 k \Omega$ :0.44 mA | See 3.6 | ||
| Note3 | |||
| Maximum Phase | |||
| Charge, ( $\mu$ C) @ | |||
| $500\Omega$ | 12uC | 13.82uC | See 3.6 |
| Note3 | |||
| Maximum Average | |||
| Current( $500\Omega$ ) | 8.49mA | 1.0mA | See 3.6 |
| Note 3 | |||
| Maximum Current | |||
| Density, (mA/cm² | |||
| @ $500\Omega$ ) | 0.34mA/cm² | 0.39mA/cm² | See 3.6 |
| Note 3 | |||
| Maximum Average | |||
| Power Density, | |||
| (W/cm²@ $500\Omega$ ) | 1.44mW/cm² | 1.66mW/cm² | See 3.6 |
| Note 3 | |||
| Frequency (Hz) | 1-100Hz | 2-125HZ | See 3.6 |
| Note 3 | |||
| Pulse | |||
| Duration(us) | 1-100 | 60-120 | See 3.6 |
| Note 3 | |||
| Burst Mode | None | None | Same |
| Timer | |||
| range(min) | 15~30 minutes can be set for | ||
| all programs(The default value | |||
| is 15 minutes) | 15 minutes for all programs | See 3.8 | |
| Note4 | |||
| Indication | |||
| display: | -On/Off status | ||
| -Low battery | -On/Off status | ||
| -Output strength | See 3.9 | ||
| Note 5 | |||
| -Voltage/Current level | |||
| -Output mode | |||
| -Time to cut-off | -Output mode | ||
| -Time to cut-off | |||
| Power Source | 4x 1.5 size AAA | 4x1.5 size AAA | Same |
| Dimension | 120.3mmx60.3mmx20.6mm | 140mmx63mmx30mm | See 3.11 |
| Note6 | |||
| Weight | 73g (exclude battery) | 88g (exclude battery) | See 3.11 |
| Note6 | |||
| Housing | |||
| Materials | ABS | ABS | Same |
| Microprocessor | |||
| control | Yes | Yes | Same |
| Automatic | |||
| Overload trip | No | No | Same |
| Automatic | |||
| no-load trip | Yes | Yes | Same |
| Automatic | |||
| shut-off | Yes | Yes | Same |
| User override | |||
| control | No | No | Same |
| Electrode | |||
| compliance with | |||
| 21 CFR 898 | Yes | Yes | Same |
| Electrode cable | Yes | Yes | Same |
7
8
Note: For the Maximum Average Power Density: Surface area: S=25 cm²; maximum average current output: 1=8.49mA; Load: R=5002; power density: P= IIR/S=0.00144(watts/cm²)
-
Note 1 The number of output mode of the new device is changed, EMC test, Electrical Safety test and particular safety test have been performed on the new device, and the result show that, the new device is the same safe and effective as the predicate device.
-
Note 2 The waveform of the new device AD-2126 is different from the predicate device, they all have the Biphasic rectangular waveform. EMC test, Electrical Safety test and particular safety test have been performed on the new device, and the result show that, the new device is the same safe and effective as the predicate device.
-
Note 3 The output specification are different from the predicate device, such as the Maximum output voltage (at 500Ω, 2 k Ω, and 10 k Ω), the Maximum Output Current (at 500Ω, 2 kΩ, and 10 kΩ), the Maximum Phase Charge(at 500Ω), the Maximum Average Current(at 500Ω), the Maximum Current Density(at 500Ω) and the Maximum Average Power Density(at 500Ω). Moreover, the frequency and time
9
duration are also changed. However, the Electrical Safety test and particular safety test can conform that, they are the same safe and effective.
-
Note 4 15-30 minutes timer range can be set for all programs, which is different from the predicate device, but the software validation can confirm that, the new device is the same safe and effective as the predicate device.
-
Note 5 The indication display of the new device is the changed, but the software validation can confirm that, the new device is the same safe and effective as the predicate device.
6.Note 6 The dimension and weight are different, because the appearance of the device is changed, however, the Electrical test report and the EMC test report for the new devices can confirm that they are the same safe and effective as the predicate device.
However, the tests in this submission demonstrates that these small differences do not raise any new questions of safety and effectiveness.