(126 days)
Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Home Care Jelly," an electroconductive media. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.
This document is a regulatory clearance letter and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot populate the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth. The letter's purpose is to grant market clearance based on substantial equivalence, not to present a detailed performance study.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 2 2002
Dr. Jen. Ken-Min ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, Taiwan, ROC
Re: K022494
Trade/Device Name: Home Care Jelly Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: September 27, 2002 Received: November 1, 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 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
{1}------------------------------------------------
Page 2 - Dr. Jen
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) 594-4639. 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,
Miriam C. Provost
for 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}------------------------------------------------
4. INDICATIONS FOR USE STATEMENT
| Applicant | HOME CARE TECHNOLOGY CO., LTD. |
|---|---|
| 510(k) Number | TO BE ASSIGNED K022494 |
| Device Name | HOME CARE JELLY |
Indications for Use :
Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
Miriam C. Provost
vision of Gene - L Restorative nd Neurological i evices
KO 22494
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).