(95 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related technologies. The description focuses on the device's function as a TENS unit using electrical stimulation.
Yes
The device is indicated for symptomatic relief of chronic intractable pain, post-traumatic, and post-surgical pain relief, which aligns with the definition of a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) indicated for pain relief, which is a therapeutic function, not a diagnostic one. It applies electrical currents to stimulate nerves for symptomatic relief, not to identify or assess a medical condition.
No
The device description explicitly states it is a "Transcutaneous Electrical Nerve Stimulator" and a "Mini Digital Wireless Patch," which are hardware components that deliver electrical stimulation. The description also mentions it is "well attached to the skin by its patch before being turned on," further indicating a physical device.
Based on the provided information, the COSMO TENS PF-990 Mini Digital Wireless Patch is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for pain relief by applying electrical currents to the body. This is a therapeutic device that interacts directly with the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The COSMO TENS PF-990 does not perform any such examination of specimens.
Therefore, the COSMO TENS PF-990 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/12 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 an abstract symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
COSMO Health, Inc. C/O Jean-Claude Amar Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re: K013507/S1
Trade/Device Name: COSMO TENS PF-990 Mini Digital Wireless Patch Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: December 27, 2001 Received: December 28, 2001
Dear Mr. Amar:
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
1
Page 2 - Mr. Jean-Claude Amar
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,
R. Mark N. Millerson
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
COSMO HEALTH. INC., NE COSMO TENS P
KOIBSTI
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Device Name:
K013507 COSMO TENS PF-990.
Indications for Use:
The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use _______ |
(Per 21 CFER 801.109) and (Optional Format 1-2-96)
for Mark N. Melkers
(Division Sign-Off Division of General Restorative and Neurological Devices
| 510(k) Number | K013507 |
|---|---|
| --------------- | --------- |
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ