(373 days)
Not Found
Not Found
No
The summary provides no information about the device's internal workings or technology, and there are no mentions of AI, ML, or related terms. The intended use is for TENS stimulation, which is a well-established, non-AI technology.
Yes
The intended use explicitly states T.E.N.S. stimulation is for "symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain," which describes therapeutic applications.
No
The "Intended Use / Indications for Use" states that T.E.N.S. stimulation is used for "symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain," which describes a therapeutic rather than a diagnostic function.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. Without this information, a definitive classification cannot be made.
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 as providing T.E.N.S. stimulation for pain relief. This is a therapeutic application, not a diagnostic one.
- 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.)
- Providing information about a patient's health status, disease, or condition based on in vitro analysis.
- Using reagents or kits for testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to deliver electrical stimulation to the body for pain management, which is a direct therapeutic intervention.
N/A
Intended Use / Indications for Use
T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Product codes
NUI-I
Device Description
Not Found
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
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
Not Found
Key Metrics
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
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BioMedical Life Systems, Inc. c/o Mr. Gary Bussett P.O. Box 1360 Vita, CA 92085
JUL 2 9 2011
Re: K102051
Trade/Device Name: Pain Buddy Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUI-I Dated: July 22. 2011 Received: July 25, 2011
Dear Mr. Bussett:
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
1
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 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/uc.ml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K102051 |
|---|---|
| Device Name: | (TENS) Trancutaneous Electrical Nerve Stimulator for Pain Relief |
| Model Name: | Pain Buddy® |
| Indications for Use: | T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. |
Prescription Use
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
| 510(k) Number | K102051 |
|---|---|
| --------------- | --------- |
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And and the commend of the comments of
موادر عمل
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