(88 days)
Not Found
No
The summary describes a standard TENS device and explicitly states that AI, DNN, or ML were "Not Found" in the relevant sections.
Yes
The device description states it is a "Transcutaneous Nerve Stimulator (TENS)" and its intended use is for "symptomatic relief of chronic intractable pain" and "adjunctive treatment in the management of postsurgical and post-traumatic acute pain," which are therapeutic applications.
No
The device description indicates it is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for symptomatic pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "Dual Channel Transcutaneous Nerve Stimulator (TENS)," which is a hardware device.
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 symptomatic relief of pain and as an adjunctive treatment for acute pain. This describes a therapeutic device that interacts with the patient's body to alleviate symptoms.
- Device Description: The device is described as a Transcutaneous Nerve Stimulator (TENS). TENS devices deliver electrical impulses through the skin to stimulate nerves, which is a physical therapy modality, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a therapeutic device used to treat pain.
N/A
Intended Use / Indications for Use
The device is intended for the symptomatic relief of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Product codes
GZJ
Device Description
The Mantra TENS Model NT3 is a Dual Channel Transcutaneous Nerve Stimulator (TENS).
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
SEP - 3 2004
Mantra International Ltd. P.O. Box 800 Oxford, OH 45056 Tel: (740) 549-5703 FAX: (740) 549-5701
510(k) Summary
| Contact Person: | Brent Reider |
|---|---|
| Date of Preparation: | March 12, 2004 |
| Trade Name: | Mantra TENS Model NT3 |
| Common Name: | Transcutaneous Nerve Stimulator |
| Classification Name: | Stimulator, Nerve, Transcutaneous, for Pain Relief |
| Product Code: | GZJ |
| Regulation Class: | 2 |
| Regulation Number: | 882.5890 |
Description of the Device: The Mantra TENS Model NT3 is a Dual Channel Transcutaneous Nerve Stimulator (TENS).
Intended Use: The device is intended for the symptomatic relief of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Technical Characteristics: The technical characteristics of the Mantra TENS Model NT3 are identical to the predicate device. The unit is battery operated and produces a biphasic asymmetrical waveform. This is a digital unit, which provides twelve pre-set programs and two user-customized programs. The electrodes consist of hydrogel in contact with the skin, a carbon conductor, and a nonwoven backing material.
There are three modes of operation: Conventional TENS, Burst Mode, and Modulation.
The Conventional TENS mode enables the user to select any rate between 2 Hz - 200 Hz, and a pulse width between 50 - 300 microseconds. This is the most frequently used of the three modes. The most common selection is 80 Hz with a 200 microsecond pulse width.
1
The burst mode is comparable to the low rate TENS technique except that each low rate pulse is substituted for by a short BURST of 9 pulses [200 microseconds] at 150 Hz.
The modulation mode is achieved by continuously cycling the pulse width and rate.
Substantial Equivalence: This product is substantially equivalent to the Classic TENS™ manufactured by Care Rehab, McLean, Virginia (K020437).
Substantial equivalence is based upon:
- . The Mantra TENS Model NT3 has the same indications for use as the predicate device.
- . The Mantra TENS Model NT3 has equivalent technological characteristics and instructions for use, as compared to the predicate device.
- . The device meets the mandatory performance standards.
- . The biocompatibility of the electrodes has been established.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
SEP 2 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mantra International Ltd. C/o Mr. Robert B. Spertell RBS Technologies, LLC 10235 Glade Avenue Chatsworth, California 91311
Re: K041520
Trade/Device Name: Mantra TENS Model NT3 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: March 9, 2004 Received: June 7, 2004
Dear Mr. Spertell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about of 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). and Cosmetion Free (110) market the device, subject to the general controls provisions of the Act. The r ou mayy and ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de ree as exactive a 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Robert B. Spertell
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls begin finding of substantial equivalence of your device to a legally premated predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Mantra TENS Model NT3 Device Name:
TENS is used for symptomatic relief and management of chronic Indications for Use: intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Ut Division of General, Restorative, and Neurological Devices
510(k) Number K041520
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