(137 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 indicated for "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," which falls under therapeutic use.
No
This device is for symptomatic relief and management of pain, which is therapeutic, not diagnostic.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the 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 and management of pain. This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Clinical Settings: The device is used on patients (at home or in hospital facilities) for pain management. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
- Lack of Mention of Biological Samples: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
The description points towards a device used for direct patient treatment or management of symptoms, not for in vitro analysis of biological specimens.
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 prescription 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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
MAY 0 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rolor Electronics Corporation C/O Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City Taiwan, ROC
Re: K014126
Trade/Device Name: Sandidad Health-Up TENS MP-73725 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: March 24, 2002 Received: March 29, 2002
Dear Dr. Jen:
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 10 mmerce 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.
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
1
Page 2 - Dr. Ke-Min Jen
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.
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 and additionally 21 CFR Part 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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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
2
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_
Indications For Use:
Ver/ 3-4/24/96
Applicant: ROLOR ELECTRONICS CORPORATION
510(k) Number ( if known): __ K 014126
Device Name: Sanidad Health-Up TENS MP-73725
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 prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Mark N Milkman
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K014126