(166 days)
Not Found
No
The description focuses on standard electrical stimulation technology with user control and sequencing, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes.
The device is used for symptomatic relief of pain, which is a therapeutic purpose.
No
The device is intended for "symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain," which describes a therapeutic rather than a diagnostic purpose. The device description also focuses on stimulation for treatment, not for diagnosis.
No
The device description explicitly lists hardware components such as a stimulator, sequencer, patient cable, and electrodes, indicating it is not a software-only device.
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, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description: The provided description clearly states the device is a "sequenced system for transcutaneous muscle stimulation." It involves applying electrodes to the skin to stimulate muscles. This is an in vivo (within the living body) application, not an in vitro test.
- Intended Use: The intended use is for "symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain." This is a therapeutic application, not a diagnostic one based on analyzing bodily specimens.
The device is a type of Transcutaneous Electrical Nerve Stimulator (TENS), which is used for pain management by applying electrical impulses to the skin. This is a common type of medical device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
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)
Non-Clinical Tests Submitted: The EVERLIFE Transcutaneous Nerve Stimulator has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. System level testing including waveform testing was performed in combination the EVERLIFE Transcutaneous Nerve Stimulator.
Clinical Tests Submitted: None
Conclusion: As the product description and tests as above, the new device: EVERLIFE Transcutaneous Nerve Stimulators are as safe and effective as, and the function in a manner equivalent to the predicate devices. Thus the new device is substantially equivalent to the predicate devices in this aspect.
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.
K902102, K931570, K012643, K021755, K970429
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
SUMMARY OF SAFETY AND EFFECTIVENESS for Transcutaneous Nerve Stimulator
510(k) No: K071624
| DATE OF
| SUBMISSION: | June 1, 2007 | |
|---|---|---|
| SUBMITTER: | EVERLIFE MEDICAL EQUIPMENT CO., LTD. | |
| NO 58, FU-CHIUN ST. | ||
| HSIN-CHU CITY, CHINA (TAIWAN) 30067 | ||
| TEL: 886-3-5208829 | ||
| FAX:886-3-5209783 | ||
| ESTABLISHMENT | ||
| REGISTRATION NO: | 3004753827 | NOV 27 2007 |
| OFFICIAL | ||
| CONTACT: | Dr. JEN, KE-MIN | |
| NO 58, FU-CHIUN ST. | ||
| HSIN-CHU CITY, CHINA (TAIWAN) 30067 | ||
| TEL: 886-3-5208829 | ||
| FAX:886-3-5209783 | ||
| TRADE NAME: | EVERLIFE Transcutaneous Nerve Stimulator, | |
| T-100201, T-100202, T-100203, T-100801, | ||
| T-100802, T-100803, T-100501, T100502, | ||
| SD-100506,T-201110, T-201210, T-201310, T-300708 | ||
| COMMON/USUAL | ||
| NAME: | Transcutaneous Nerve Stimulator | |
| CLASSIFICATION | ||
| NAME: | Transcutaneous Nerve Stimulator | |
| REGULATION | ||
| NUMBER: | 882.5890, GZJ, Class II | |
| PREDICATED | ||
| DEVICE: | APEX Transcutaneous Nerve Stimulator, | |
| K902102, K931570, K012643, K021755, K970429, | ||
| ( Please refer to the following comparison page.) | ||
| INTENDED USE: | To be used in symptomatic relief of chronic intractable | |
| pain, post-traumatic and post surgical pain |
1
Comparison for Predicate Device & Subject Device
| 510K
Number | APEX Model
(predicate device) | Everlife Model
(new device) | Note |
|----------------|----------------------------------|--------------------------------|-------------------------|
| K902102 | COM-TENS | T-100201 | Identical |
| | | T-100202 | Substantial Equivalence |
| | | T-100501 | Substantial Equivalence |
| | | T-100502 | Substantial Equivalence |
| | | T-100801 | Substantial Equivalence |
| | | T100802 | Substantial Equivalence |
| K931570 | COM-TENS
(Single Mode) | T-100203 | Identical |
| | | T-100803 | Substantial Equivalence |
| K012643 | Apex Medical
LCD TENS-VII | T-300708 | Identical |
| K021755 | TS-1211 | T-201110 | Identical |
| | TS-1211 | T-201310 | Substantial Equivalence |
| K021755 | TS-1212 | T-201210 | Identical |
| K970429 | BIOSCOPE
SD TENS | SD-100506 | Identical |
、
2
| Description of Device: | A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence. |
|---|---|
| Non-Clinical Tests Submitted: | The EVERLIFE Transcutaneous Nerve Stimulator has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. System level testing including waveform testing was performed in combination the EVERLIFE Transcutaneous Nerve Stimulator. |
| Clinical Tests Submitted: | None |
| Conclusion: | As the product description and tests as above, the new device: EVERLIFE Transcutaneous Nerve Stimulators are as safe and effective as, and the function in a manner equivalent to the predicate devices. Thus the new device is substantially equivalent to the predicate devices in this aspect. |
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
NOV 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everlife Medical Equipment Co., Ltd. % Dr. Jen Ke-Min No. 58, Fu Chiun Street I Isin Chu City, 30067 Taiwan, ROC
Re: K071624
Trade/Device Name: Everlife Transcutaneous Nerve Stimulator models T-100201, T-100202, T-100501, T-100502, T-100801, T-100802, T-100203, T-100803, T-300708, T-201110, T-201310, T-201210, SD-100506 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 29, 2007 Received: November 6, 2007
Dear Dr. Jen Ke-Min:
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 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.
4
Page 2 – Dr. Jen Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ought mating of substantial equivalence of your device to a legally prematics notification: "The PDF Interessification 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 11 you active epper for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 276 0126. Fire Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Nedical Donoc Reporting (112)); per general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Mark N. Melkerson Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number: | K071624 |
|---|---|
| ---------------- | --------- |
Device Name:
EVERLIFE Transcutaneous Nerve Stimulator, T-100201, T-100202, T-100203, J T-100801, T-100802, T-100803, T-100501, T100502, SD-100506, T-201110, T-201210, T-201310, T-300708
Indications for Use :
To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.
Prescription Use V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) Division of General, Restorative, and Neurological Device
510(k) Num