(214 days)
Not Found
Not Found
No
The provided 510(k) summary describes a device with various electrical stimulation modalities for pain management and muscle therapy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The description focuses on the intended uses and the types of electrical stimulation delivered.
Yes
The "Intended Use / Indications for Use" section explicitly lists medical conditions for which the device is used to provide relief, prevention, or stimulation, such as "Relaxation of muscle spasms," "Symptomatic relief of chronic, intractable pain," and "Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis." These are therapeutic applications.
No
The "Intended Use / Indications for Use" section lists therapeutic applications such as pain relief, muscle relaxation, and prevention of atrophy, but no diagnostic purposes.
Unknown
The provided text only describes the intended use/indications for use. It lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The listed indications for use (muscle stimulation, pain management) are typically associated with hardware-based electrical stimulation devices. Without a device description, it's impossible to confirm if this is a software-only device controlling external hardware or a software application providing other functionalities related to these indications.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (muscle relaxation, pain relief, etc.) are all related to therapeutic applications on the human body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions.
- Device Description: While the description is "Not Found," the intended uses clearly point to a physical therapy or pain management device, not a diagnostic one.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For VMS, Russian, Monophasic Hi-Volt
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis 를
For Microcurrent, Interferential and Premodulated
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions I
Product codes
GZJ, LIH, IPF, IMG, IMI
Device Description
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Ms. Cheryl G. Dyer Regulatory Compliance Specialist Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489
K982317 Re: Vectra 2C and Vectra 4C Trade Names: GZJ, LIH, IPF, IMG, and IMI Product Codes: K982321 Vectra 2S and Vectra 4S Trade Names: Product Codes: GZJ, LIH, and IPF K982324 Vectra Pro 2 and Vectra Pro 4 Trade Names: GZJ, LIH, IPF, IMG, and IMI Product Codes: Regulatory Class: II December 10, 1999 Dated: December 11, 1999 Received:
Dear Ms. Dyer:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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, Druq, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class (Special Controls) or class III (Premarket Approval), they II may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
1
Page 2 - Ms. Cheryl G. Dyer
In addition, FDA may publish further announcements action. concerning your devices 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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note 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,
le Mark n mllkerson
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Image /page/2/Picture/1 description: The image shows the logo for Chattanooga Group, Inc. The logo consists of a stylized letter "C" on the left, followed by the words "CHATTANOOGA" on the top line and "GROUP, INC." on the bottom line. A horizontal line separates the two lines of text. The logo is black and white.
INDICATIONS
For VMS, Russian, Monophasic Hi-Volt
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis 를
For Microcurrent, Interferential and Premodulated
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions I
Mark M. Milkerson
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982321
Prescription Use
(Per 21 CFR 801.109)
4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-870-7404