(64 days)
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.
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.
This 510(k) summary for the EasyMed TN-28C T.E.N.S. Unit does not describe a study involving acceptance criteria and device performance in the way a clinical study for an AI/ML device would. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (FDTENS 2010), primarily through a comparison of design principles, power sources, and electrical output parameters.
Therefore, many of the requested fields cannot be filled as they pertain to a type of study not conducted or reported in this document.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable (N/A). The document does not describe specific quantitative acceptance criteria and corresponding measured device performance data. The basis for equivalence is a qualitative and parametric comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
N/A. No test set or associated data provenance is described for performance evaluation in the context of efficacy for pain relief in a human population. The comparison is based on device specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications
N/A. This document does not describe a study that required expert consensus for ground truth.
4. Adjudication Method
N/A. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. An MRMC study was not conducted or reported for this Transcutaneous Electrical Nerve Stimulator (TENS) unit. These studies are typically relevant for diagnostic imaging or AI-assisted interpretation, which is not the function of a TENS device.
6. Standalone Performance Study
N/A. While the document describes the technical specifications and operational principles of the device, it does not present a standalone performance study in terms of its clinical effectiveness or diagnostic accuracy. The equivalence is established on technical similarity, not a standalone clinical outcome study for the new device.
7. Type of Ground Truth Used
N/A. No ground truth is described, as the submission focuses on substantial equivalence based on technical specifications and intended use matching a predicate device.
8. Sample Size for the Training Set
N/A. This TENS device is not an AI/ML device, and thus, there is no "training set."
9. How Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no training set mentioned.
Summary of the K040253 Submission:
The EasyMed TN-28C T.E.N.S. Unit obtained 510(k) clearance by demonstrating substantial equivalence to a previously legally marketed device, the FDTENS 2010 (K994266). The submission emphasizes that:
- Their circuits design are based on the same principle.
- Both devices use two 1.5V AA batteries and have two output channels.
- Their output electrical parameters (frequency, pulse width, intensity, etc.) are very similar substantially.
- The intended use of providing symptomatic pain relief for chronic, acute, or post-operative pain is the same as the predicate device.
This type of 510(k) submission, especially for a well-established device type like a TENS unit, typically relies on comparing technical specifications and intended use to a predicate device rather than conducting extensive new clinical performance studies with acceptance criteria as one might see for novel AI software or high-risk devices. The FDA's letter explicitly states that the determination of substantial equivalence allows the device to be marketed, subject to general controls.
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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:
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- 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
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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.
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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
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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
§ 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).