(90 days)
Not Found
No
The summary describes a portable interferential device for pain control and mentions bench testing for substantial equivalence to a predicate device. There is no mention of AI, ML, image processing, or any data sets typically associated with AI/ML development or validation.
Yes
The device is described as an "Interferential device for pain control" and its intended use is "Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain," which are therapeutic applications.
No
The device is described as an "Interferential device for pain control" intended for "Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain." This indicates a therapeutic, not diagnostic, use.
No
The device description explicitly states it is a "portable Interferential device for pain control," which implies a hardware component that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain." This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a "portable Interferential device for pain control." This further reinforces its therapeutic function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro testing.
- Using reagents or assays.
The device is a therapeutic device that uses electrical stimulation (Interferential) to manage pain.
N/A
Intended Use / Indications for Use
Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain
Product codes
LIH
Device Description
A portable Interferential 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
Bench testing demonstrated that the output characteristics or CARE IFC plus™ are substantially equivalent to that of the predicate device.
Key Metrics
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
MAY 1 6 2002
13 Appendix G: 510 (k) Summary
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: | May 14, 2002 | |
| Proprietary Name: | CARE IFC plus™ | |
| Common Name: | Interferential Stimulator (LIH) | |
| Classification Name: | Stimulator Interferential (LIH); Unclassified | |
| Device Classification: | Unclassified | |
| Predicate Device: | HMP4000 Interferential Stimulator (K924961) | |
| Description of Device: | A portable Interferential device for pain control | |
| Intended Use: | Interferential treatment is used for symptomatic relief of chronic
intractable pain and/or as an adjunctive treatment in the management of
postsurgical and posttraumatic acute pain. | |
| Technological Comparison: | The CARE IFC plus™ has technological characteristics that are
substantially equivalent to those of the predicate device, as determined
by bench testing. | |
| Labeling Comparison: | The labeling of the CARE IFC plus™ is substantially equivalent to that
of the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARE
IFC plus™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE IFC plus™ 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. | |
ર I
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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Christian E. Hunt Care Rehab 1124 Dominion Ct. McLean, VA 22102
Re: K020516
Trade/Device Name: CARE IFC plus Regulatory Class: Unclassified Product Code: LIH Dated: February 14, 2002 Received: February 15, 2002
Dear Mr. Hunt:
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. 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.
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Page 2 - Mr. Christian Hunt
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-. 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,
Miriam C. Provost
O 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
3
4 Indications for Use
510(k) Number:
Device Name: CARE IFC plus™
Indications for Use:
Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0205/6
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