(88 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 intended for the symptomatic relief and management of chronic pain and as an adjunctive treatment for acute pain, which are therapeutic applications.
No
The "Intended Use / Indications for Use" section specifies the device is for "symptomatic relief and management of chronic (long term) intractable pain" and as an "adjunctive treatment in the management of post surgical and post traumatic acute pain problems." These are therapeutic or pain management functions, not diagnostic ones.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware 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 as being used for the symptomatic relief and management of pain. This is a therapeutic or pain management function, not a diagnostic function performed on in vitro samples (like blood, urine, or tissue).
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
The description points towards a device that interacts with the body to alleviate pain, which is characteristic of a physical therapy or pain management device, not an IVD.
N/A
Intended Use / Indications for Use
ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.
Product codes
LIH
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
PHYSICIAN
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): 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 shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle with three wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 1998
Mr. George K. C. Chen Skylark Device Company Limited Chunq Shan North Road 12th Floor, 34, Section 3 Taipei, Taiwan
Re : K974585 Trade Name: IF-727 Interferential Stimulator Requlatory Class: Unclassified Product Code: LIH Dated: November 27, 1997 Received: December 8, 1997
Dear Mr. Chen:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory -------In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. George K. C. Chen
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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/
f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Page_ 1 of 1
510(k) Number (if known):
Device Name: IF-727 INTERFERENTIAL STIMULATOR
Indications For Use:
ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. KEEP OUT OF THE REACH OF CHILDREN.
(F_EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF **EEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974585 |
| Prescription Use | X |
| (Per 21 CFR 801.1091) | |
| OR | |
| Over-The-Counter Use | ______ |
| (Optional Format 1-2-96) |