(200 days)
Not Found
Not Found
No
The provided text only describes manual and auto modes for pain relief and muscle stimulation, with no mention of AI, ML, or related concepts.
Yes
The device is intended for the temporary relief and symptomatic relief of pain, and to stimulate muscles to improve performance, which are therapeutic uses.
No
The "Intended Use / Indications for Use" section clearly states that the device is for "temporary relief of pain" and "symptomatic relief and management of chronic, intractable pain," as well as to "stimulate healthy muscles." These uses are therapeutic and do not involve diagnosing a condition or disease.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes the application of the device, but not its physical form or components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for temporary relief of pain in muscles and for stimulating healthy muscles. This involves direct interaction with the body for therapeutic purposes.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Device Description: While the device description is "Not Found," the intended use clearly indicates a therapeutic device, not a diagnostic one.
- Other Information: The lack of mentions of image processing, AI/ML, input imaging modality, and performance studies related to diagnostic accuracy further supports that this is not an IVD.
This device appears to be a therapeutic device, likely a form of electrical muscle stimulator (EMS) or transcutaneous electrical nerve stimulation (TENS) device, based on its intended uses for pain relief and muscle stimulation.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4.
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3.
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto1 or Auto 4.
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4.
Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.
Product codes
NUH, NYN, NYN, NGX, GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower back, upper extremities (arm), lower extremities (leg)
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features three diagonal lines that curve and merge into a single line at the bottom. The symbol is positioned to the right of the department's name, which is written in a circular arrangement around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2013
Endurance Therapeutics C/O Brad Brezden 122B First Street, NE Dauphin. Manitoba Canada, R7N IB5
Re: K124055
Trade/Device Name: T1040 aka Aurawave Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NYN, NYN, NGX, GZJ Dated: July 8, 2013 Received: July 15, 2013
Dear Mr. Brad Brezden
We have reviewed your Section 510(k) promarket 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 docs 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 is 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); and if applicable, the electronic product radiation control provisions (Sections 531-342 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Brad Brezden
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYow/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address: http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting 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): K124055
Device Name: T1040
Indications For Use:
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4.
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3.
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto1 or Auto 4.
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4.
Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ので、この時には、その他の人気の人気の人気の人気の人気の人気の人気の人気の出来ないと思います。 この時は、 この時には、 この日に、 この
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Victor Krauthamer -S | |
|---|---|
| 2013.07.18 18:05:41 -04'00' | |
| (Division Sign Off) | |
| Division of Neurological and Physical Medicine Devices (DNPMD) | |
| 510(k) Number | K124055 |
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