(90 days)
Not Found
No
The summary describes a standard TENS device and does not mention any AI or ML capabilities.
Yes
The device is described as a TENS unit 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 are therapeutic applications.
No
Explanation: The device, a TENS unit, is described for "symptomatic relief and management of chronic intractable pain" and as an "adjunctive treatment in the management of postsurgical and posttraumatic acute pain." Its stated purpose is therapeutic, not diagnostic.
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 performance studies also refer to "output characteristics," further suggesting a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain." This describes a therapeutic device that applies electrical stimulation to the body.
- Device Description: The description is "A portable TENS device for pain control." TENS (Transcutaneous Electrical Nerve Stimulation) is a non-invasive therapy that delivers electrical impulses through the skin.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or other materials to perform tests outside the body.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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)
GZJ
Device Description
A portable TENS device for pain control.
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 CARE 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.
Matrix I (K895473)
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
.
12 Appendix F: 510(k) Summary
人 | 天
:
510(k) Summary
| Submitter's Information: | Christian E. Hunt
Care Rehab®
1124 Dominion Ct
McLean, VA 22102 | Phone: 1-703-448-9644
FAX: 1-703-356-2182. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of preparation: | November 9, 1998 | |
| Proprietary Name: | CARE TENSTM | |
| Common Name: | TENS device | |
| Classification Name: | Stimulator, Nerve, Transcutaneous, For Pain Relief
84GZJ; 21 CFR 882.5890. | |
| Device Classification: | Class II | |
| Predicate Device: | Matrix I (K895473) | |
| Description of Device: | A portable TENS device for pain control. | |
| Intended 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. | |
| Technological Comparison: | The CARE TENS 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 Patient
Cables" | |
| Labeling Comparison: | The labeling of the CARE TENS is substantially equivalent to
that of the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics
or CARE TENS are substantially equivalent to that of the
predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE TENS 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. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing right, and the text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. Christian E. Hunt President Care Rehab and Orthopaedic Products, Inc. P.O. Box 580 22101 McLean, Virginia
Re: K984025 Trade Name: CARE TENS™ Regulatory Class: II Product Code: GZJ November 9, 1998 Dated: November 12, 1998 Received:
Dear Mr. Hunt:
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Christian E. Hunt
This letter will allow you to begin marketing your device as described in your 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 and additionally 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 Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use 4
984025 510(k) Number:
Device Name: CARE TENS
Indications for Use:
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an I ENO is used for symptomatio reast and 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)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division General Re 510(k) Number