(64 days)
Not Found
No
The description focuses on the mechanism of TENS therapy and does not mention any AI or ML components.
Yes
The device is described as "symptomatic pain relief for chronic, acute or post-operative pain" and works by "sending small electrical pulses through the skin to the body's nervous system," which directly indicates a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that the T.E.N.S. system is "used to provide symptomatic pain relief," which describes a therapeutic function, not a diagnostic one. It does not mention identifying, analyzing, or diagnosing any medical condition.
No
The device description explicitly states it is a "T.E.N.S. Unit" and describes sending "small electrical pulses through the skin," which indicates a hardware component is involved in delivering the therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "to provide symptomatic pain relief for chronic, acute or post-operative pain." This is a therapeutic application, not a diagnostic one.
- Device Description: The description explains how the device works by sending electrical pulses through the skin to the nervous system for pain control. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This T.E.N.S. device directly interacts with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.
The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the "gate" theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.
Features:
- Innovative design
- Large display
- Adjustable frequency
- 5 different modes
- Timer option
- Adjustable pulse width
- Open circuit detectors
- Non-volatile
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.
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
APR = 8 2004
K040253
page 1 of 2
510(k) Summary
Submitter: EasyMed Instrument Co., Ltd Add: 2/F-3/F. No.2 BeiHai Da Rd LunJiao, Shunde, Guangdong, China Tel: 0086-765-7727282 7727283 Fax: 0086-765-7727868
Submitted Device:
Trade name: EasyMed TN-28C TENS UNIT Common name: Transcutaneous Electrical Nerve Stimulator (T.E.N.S)
ldentification of the legally marketed device
The legally marketed device which EasyMed is claiming equivalence: 510(k) No: K994266 Device name: FDTENS 2010 Manufacturer: Fuji Dynamics Ltd
The TN-28C TENS Unit is SE to the FDTENS 2010, their circuits design are based on the same principle; Both of them use two 1.5V AA batteries and have two output channels; their output electrical parameters, frequency, pulse width, and intensity, etc., are very similar substantially
Description of the submitted device
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.
The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.
Features:
1
- Innovative design
- Large display
- Adjustable frequency
- 5 different modes
- Timer option
- Adjustable pulse width
- Open circuit detectors
- Non-volatile
The intended use of the device:
TN-28C T.E.N.S UNIT is commonly used to provide symptomatic pain relief for chronic, acute or post-operative pain.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
APR = 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EasyMed Instrument Co., Ltd. c/o Mr. Stefan Preiss TÜV Product Servicc 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K040253
Trade/Device Name: EasyMed TN-28C T.E.N.S. Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: March 22, 2004 Received: March 24, 2004
Dear Mr. Preiss:
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 cither 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 complics 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.
3
Page 2 - Mr. Stefan Preiss
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
sincerely yours,
Mark H. Wilkerson
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
4
Indications for Use
510(k) Number (if known): _K040253
Device Name: EasyMed TN-28C T.E.N.S. UNIT
Indications For Use:
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system 1 .E.N.O. Stands for Transoutanoous Ellef for chronic, acute or post operative pain.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
Mark N Mellers
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of __
510(k) Number. K040253