(66 days)
Not Found
No
The description details a standard TENS device with no mention of AI or ML capabilities.
Yes
The device is used 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 indicates a therapeutic purpose.
No
The device, a TENS unit, is described as providing symptomatic relief and managing pain by transmitting electrical impulses. It does not perform any diagnostic function to identify or characterize a disease or condition.
No
The device description explicitly lists hardware components such as the device itself, a battery, electrodes, lead wires, and a carrying case, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain relief and management, which is a therapeutic application, not a diagnostic one.
- Device Description: The device description clearly states it's a transcutaneous electrical nerve stimulator (TENS) that delivers electrical impulses through the skin. This is a physical therapy modality, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This TENS device does not fit that description.
N/A
Intended Use / Indications for Use
The TENS is used 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.
Product codes
GZJ
Device Description
The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Koy1092
510 (k) SUMMARY
JUL 01 2004
| Statement: | This summary of 510(k) substantial equivalence is
being submitted in accordance with the
requirements of 21 CFR 807.92 and can be used to
provide a substantial equivalence summary to
anyone requesting it from the Agency. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Identification: | Vision Quest Industries, Inc.
18011 Mitchell South
Irvine, CA 92614
Contact Person: Jaime Pulley, VP of Quality
Assurance/Regulatory Affairs
Phone: (949) 794-3865
Fax: (949) 477-9672 |
| Date Summary Prepared: | April 21, 2004 |
| Name of Device: | Proprietary Name: Fast Start® TENS
Common Name: (TENS) Transcutaneous Electrical
Nerve Stimulator |
| Classification Name: | Stimulator, Nerve, Transcutaneous, for pain relief
(GZJ) |
| Predicate Device Name: | Classic TENSTM
510(k) Number K020437
Mantra International Ltd.
Room L-5 15/F Blk B, Vigor Industrial
Building. 20 Cheung Tai Road
Tsing Yi, Hong Kong |
Device Description:
The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.
Indications for Use
The TENS is used for symptomatic relief and management of chronic intractable pain,
1
510(k) Summary (continued)
and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.
Comparison to Predicate
This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications.
Conclusion
Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation: Conventional, Burst, and Modulated. It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
JUL 0 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jaime X. Pulley Vice President of Quality Assurance and Regulatory Affairs VisionOuest Industries. Inc. 18011 Mitchell South Irvine, California 92614
Re: K041092
Trade/Device Name: FastStart® TENS, Model FS 3001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 21, 2004 Received: April 26, 2004
Dear Mr. Pulley:
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.
3
Page 2 -- Jaime X. Pulley
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.
Miriam C. Provost
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): K041092
Device Name: __ Fast Start TENS
Indications For Use:
The TENS is used 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
Prescription Use X (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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_ K04/092