(17 days)
Not Found
No
The description details a standard TENS device with preset programs and adjustable intensity, with no mention of AI or ML capabilities.
Yes
The device is intended for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which are therapeutic purposes.
No
The device description states its use is for "symptomatic relief and management of chronic intractable pain" and "as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which are therapeutic rather than diagnostic purposes. It works by generating electrical pulses to block pain signals, not to detect or identify a medical condition.
No
The device description explicitly states it is a "handheld battery powered TENS device" that "generate[s] electrical pulses and transmit[s] it to the electrodes," indicating it is a hardware device with electrical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This includes tests for diagnosing, monitoring, or screening for diseases or conditions.
- L-TENS Function: The L-TENS device described is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It works by applying electrical pulses to the skin to alleviate pain. It does not analyze any biological specimens from the patient.
The description clearly states its function is to generate electrical pulses and transmit them to electrodes on the patient's skin for pain relief. This is a physical therapy or pain management device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The L-TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The L-TENS is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.
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 Applicable as there are no new or innovative aspects that have been introduced.
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.
FDTENS 2010 (K994266)
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
MAY 2 0 2004
10 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
10.1 Submitter's Identification
Fuji Dynamics Ltd. Unit 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road, Kowloon, Hong Kong Tel: (852) 2786 4218 Fax: (852) 2744 6775
Contact Person: Anthony Ah Yin, Shum April 29th 2004 Date Prepared:
10.2 Name of Device:
| Proprietary Name: | L-TENS |
|---|---|
| Common or Usual Name: | TENS unit |
| Classification Name: | Stimulator, Nerve, Transcutaneous, for Pain Relief |
| (21 CFR 882.5890) | |
| Device Classification: | Class II |
10.3 Predicate Device Information:
The L-TENS is equivalent to the FDTENS 2010 (K994266).
10.4 Device Description:
The L-TENS is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.
1
10.5 Intended Use:
TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
10.6 Technological Comparison to Predicate Device:
The L-TENS has basic technological characteristics that are substantially equivalent to the predicate device. Both devices are battery powered and have adjustable output amplitudes. On the contrary, the legally marketed predicate device has dual channels, while L-TENS is a 1-channel device. The only significant technological difference between the two devices is that L-TENS possesses an open-circuit detection feature. It means that L-TENS could check the continuity between the output terminals, and avoid increment of output in the absence of load.
All units use "shrouded patient cable connectors" to comply with the FDA's Final Rule "Mcdical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."
10.7 Non-clinical Testing:
Compliance to applicable voluntary standards includes ANSVAAMI NS4-1986, as well as EN 60601-1, EN 60601-1-1 and EN 60601-1-2 requirements.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
10.8 Clinical Testing
Not Applicable as there are no new or innovative aspects that have been introduced.
10.9 Conclusions:
The L-TENS has the same intended use and similar technical characteristics as the FDTENS 2010 (K994266).
The information supplied in this 510(k) illustrates that the device do not pose any new questions of safety and effectiveness. Therefore, the L-TENS is substantially equivalent to the predicate device.
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2004
Anthony Ah Yin, Shum R & D Department Unit 1-3, Laws Commercial Plaza 788 Cheung Sha Wan Road Hong Kong. China
Re: K041164
Trade/Device Name: L-TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: April 30, 2004 Received: May 3, 2004
Dear Mr. Shum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 adviscd that FDA's issuance of a substantial equivalence determination docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Anthony Ah Yin, Shum
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotest 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 responsibilitics 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,
Mark A. Milburn
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):
Device Name: L-TENS
Indications For Use:
The L-TENS is used for the symptomatic rclief and management of chronic intractable pain The 1.- I ENS is used in the symptomation of post-surgical and post-surgical and post-traumatic 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
for Mark
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K091169 |
|---|---|
| --------------- | --------- |
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