(27 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available.
Yes
The device is intended for "symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain," which are therapeutic applications.
No
Explanation: The device is intended for symptomatic pain relief, which is a therapeutic rather than a diagnostic function.
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, the Mini TENS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain." This describes a therapeutic device that applies electrical stimulation to the body for pain management.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Mini TENS does not involve any such specimen analysis.
Therefore, the Mini TENS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2002
Alan Chang Apex Medical Corp. 10th Floor, No. 31 Lane 169 Kang-Ning St. Shi-Chih, Taipei Hsien, Taiwan, R.O.C.
Re: K020032
Trade/Device Name: Apex Medical Mini TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: January 2, 2002 Received: January 4, 2002
Dear Mr. Chang:
We have reviewed your Scetion 510(k) promarket 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
1
Page 2 – Mr. Alan Chang
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
led the election and consection (21 CER Part 820); and if applicable, the electroni CFR Part 807); labeling (21 CFR Part 801); good manufacturing pricable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if annolicable, 105 forth in the quality systems (QS) regulation (21 CFR Part 25) 213-111 (1)
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)
The status and consember of a lies of a betertial aquivalence of your device to This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA Imaling of substantial equivalence or your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device directions on the entired to Office of
additionally 21 CFR Part 809.10 for in the securities on the resemblion and advertising additionally 21 CFR Part 809.10 ID III Yuu utenover do noon) promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and adve Compliance at (301) 594-4659. Additions of Compliance at (301) S94-4639. Also, please note the your device, please confact the Office of Complants an (or) of including (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarkst notification's be regulation entitled, "Misbranding by reference or promoter the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Siman Manarace, 16197 or at its Internet address (800) 038-2041 01 (301) 113-0597 0857 085 http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Mark N Milken
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 : 长ዕ೭૦૦૩ટ Device Name : Apex Medical Mini TENS Indications For Use:
Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.
(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-Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
fo Ma. N. Millison
f General. Restorative and Neurological Decices
510(k) Number_