(35 days)
Not Found
No
The summary describes a standard TENS device and does not mention any AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" states that TENS is used for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain," which describes a therapeutic purpose.
No
The provided text for "Intended Use / Indications for Use" states that TENS is used for "symptomatic relief and management of chronic intractable pain" and "as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain." This describes a therapeutic device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description explicitly states it is a "portable TENS device," which implies a physical hardware component is involved in delivering the electrical stimulation. The summary also mentions "output characteristics," which are typically associated with hardware performance.
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 description of a "portable TENS device for pain control" aligns with a therapeutic device that delivers electrical stimulation to the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
TENS devices work by applying electrical stimulation to the nerves to block pain signals or stimulate the release of endorphins. This is a direct interaction with the body for therapeutic effect, not an in vitro analysis for diagnostic purposes.
N/A
Intended Use / Indications for Use
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
Product codes (comma separated list FDA assigned to the subject device)
84GZJ
Device Description
The CLASSIC TENSTM is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.
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)
Bench testing demonstrated that the output characteristics or CLASSIC TENS™ are substantially equivalent to that of the predicate device.
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
11 Appendix E: 510 (k) Summary
510(k) Summary
Stimulator, Nerve, Transcutaneous, For Pain Relief
A portable TENS device for pain control.
postsurgical and posttraumatic acute pain.
KD20437
Submitter's Information:
Christian E. Hunt Care Rehab 1124 Dominion Ct McLean, VA 22102
February 5, 2002
CLASSIC TENS™
84GZJ; 21 CFR 882.5890.
Matrix I (K895473)
Patient Cables"
of the predicate device.
TENS device
Class II
Phone: 1-703-448-9644 FAX: 1-703-356-2182.
Date of preparation:
Proprietary Name:
Common Name:
Classification Name:
Device Classification:
Predicate Device:
Description of Device:
Intended Use:
Technological Comparison:
Labeling Comparison:
Nonclinical Testing:
Clinical Testing:
Conclusions from Testing:
Not applicable.
TENS™ are substantially equivalent to that of the predicate device.
The CLASSIC TENSTM is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.
TENS is used for symptomatic relief and management of chronic
intractable pain and/or as an adjunctive treatment in the management of
The CLASSIC TENSTM has technological characteristics which are
substantially equivalent to those of the predicate device, as determined by bench testing. It differs technologically only by the use of jacks and cables which comply with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and
The labeling of the CLASSIC TENS™ is substantially equivalent to that
Bench testing demonstrated that the output characteristics or CLASSIC
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. Christian E. Hunt Care Rehab, Inc. P. O. Box 580 1124 Dominion Court McLean, Virginia 22102
Re: K020437
Trade Name: CLASSIC TENSTM Regulation Number: 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Code: GZJ Dated: February 5, 2002 . Received: February 8, 2002
Dear Mr. Hunt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
Page 2 - Mr. Christian Hunt
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loket withination. The FDA finding of substantial equivalence of your device to a legally premated 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 responsibilities 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.
Sincerely yours,
Malm M Mllersa
Witten. Ph.D .. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use 4
510(k) Number:
Device Name: CLASSIC TENS™
Indications for Use:
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mcllerson
(Division Sign-Off)
510(k) N
6