(217 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is used for "symptomatic relief and management of chronic, intractable pain" and "adjunctive treatment in the management of post surgical and post traumatic acute pain problems," which classifies it as a therapeutic device.
No
The device is described as providing "symptomatic relief and management of chronic, intractable pain" and "adjunctive treatment," indicating a therapeutic rather than diagnostic purpose. It does not mention identifying or characterizing a disease.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes any hardware components.
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 and management of pain. This is a therapeutic application, not a diagnostic one.
- Clinical Settings: The device is used for treatment, not for analyzing samples from the human body to provide diagnostic information.
- No mention of in vitro analysis: There is no indication that this device is used to examine specimens (like blood, urine, tissue) outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is clearly related to pain management, which is a treatment.
N/A
Intended Use / Indications for Use
- Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.
Product codes
GZJ
Device Description
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Mentions image processing
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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
qualified health professionals prior to the applications of the device at home or hospital facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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 is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with three stylized wing segments. The eagle faces to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 - 2005
Tung Fu Electric Co., Ltd. c/o Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society 58 Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300
Re: K042107
Trade/Device Name: Tung Fu Airmate Tens-Vitality Mode TF-DT001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: II Product Code: GZJ Dated: December 23, 2004 Received: January 7. 2005
Dear Dr. Jen:
We have reviewed your Scction 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. Iisting 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 may be subject to such 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); 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 Acti: 21 CFR 1000-1050,
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Page 2 - Dr. Jen, Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincercly yours.
Stupt Rhodes
Miriam C. Provost. Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number: TBA
TUNG FU AIRMATE TENS – VITALITY MODE Device Name: TF-DT001
Indications For Use:
- Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.
Prescription Use V (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 Office of Device of Device Evaluation (ODE) Division - Par
and Neuropa
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510(k) Number .