(323 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is also "Not Found," and the intended use is a simple electrical stimulation for nausea relief.
Yes
The device is intended to relieve nausea and vomiting due to motion sickness, which is a therapeutic function.
No
The device is used to apply electrical current to relieve symptoms (nausea and vomiting), which is a therapeutic function, not a diagnostic one. It does not identify or diagnose a condition.
No
The intended use explicitly describes applying a minor electrical current to electrodes on the patient's wrist skin, which requires hardware components (electrodes and a current generator) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply electrical current to the patient's wrist skin to relieve nausea and vomiting due to motion sickness. This is a direct interaction with the patient's body for a therapeutic purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing any biological samples.
- Anatomical Site: The device is applied to the wrist skin, which is an external application to the body, not a sample taken from the body.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
used to apply a minor electrical current to electrodes on patient's wrist skin to function as:
- Helping relieve nausea and vomiting due to motion sickness.
Product codes
GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's wrist skin
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 (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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three heads, representing the department's focus on health, services, and people. The figure is surrounded by the text "DEPARTMENT OF HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
MAY - 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HIVOX BIOTEK, Inc. C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, ROC
Re: K021952/S2
Trade/Device Name: DM-800 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: March 8, 2003 Received: March 14, 2003
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 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.
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 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
1
Page 2 - Dr. Ke-Min Jen
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,
Mark N Millerm
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
Indications for Use Statement
Applicant: _HIVQX BIQTEK INC.
510(k) Number ( if known): __________________________________________________________________________________________________________________________________________________
Device Name: HIVOX DM-800_
Indications for use: used to apply a minor electrical current to electrodes on patient's wrist skin to function as:
- Helping relieve nausea and vomiting due to motion sickness. 트
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR | Over - The - Counter - Use_ \u2713 |
|---|---|---|
| ( Per 21 CFR 801.109 ) | ( Optional Format 1-2-96 ) |
for
Mark N Millkenn
(Division Sign-Off)
Division
Restorative
and Neurological Devices
| 510(k) Number_ | K021952 |
|---|---|
| ---------------- | --------- |