(56 days)
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No
The document describes a device for electrical muscle stimulation and pain management, listing standard therapeutic uses. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is intended for medical purposes such as pain relief, muscle treatment, and prevention of venous thrombosis, as indicated by its "Intended Use / Indications for Use" section.
No
The "Intended Use / Indications for Use" section lists therapeutic applications such as pain relief, muscle re-education, and prevention of venous thrombosis, but does not mention any diagnostic functions.
Unknown
The provided text is a 510(k) summary excerpt focusing on intended use and indications. It lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications (muscle relaxation, atrophy prevention, blood circulation, muscle re-education, range of motion, venous thrombosis prevention, pain relief) are all related to physical therapy and pain management, which are applications of medical devices used on the body, not in vitro (outside the body) for diagnostic purposes.
- Device Description, Image Processing, AI/ML, Input Imaging Modality: The absence of information in these sections further supports that this is not an imaging or AI-driven diagnostic device.
- Anatomical Site: The mention of "calf muscles" indicates a device applied to a specific part of the body.
- Intended User/Care Setting: "Prescription Use" is common for therapeutic medical devices.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
In summary, the intended uses and the lack of information related to diagnostic processes clearly indicate that this device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Russian
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Fi Maintaining or increasing range of motion
- 이 Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Monophasic Hi-Volt
- 프 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
For Interferential and Premodulated
- 1 Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Product codes
GZJ, IPF, LIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Incorporated 4717 Adams Road Hixson, Tennessee 37343
Re: K974497
Trade Name: Intelect Legend Stim Regulatory Class: II Product Code: GZJ, IPF and LIH Dated: November 18, 1997 Received: November 28, 1997
Dear Mr. Elrod:
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 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 (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. A substantially equivalent determination assumes compliance with the " current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
1
Page 2 - Mr. Elrod
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 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,
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
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Image /page/2/Picture/0 description: The image shows the logo for Chattanooga Group, Inc. The logo consists of a stylized, abstract shape on the left, resembling a letter "C" or a curved shape within a square. To the right of the shape, the text "CHATTANOOGA" is printed in bold, uppercase letters, with a horizontal line underneath. Below the line, the text "GROUP, INC." is printed in a smaller, bold, uppercase font.
STATEMENT OF INDICATIONS FOR USE
For Russian
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Fi Maintaining or increasing range of motion
- 이 Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Monophasic Hi-Volt
- 프 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
For Interferential and Premodulated
- 1 Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Prescription Use
(Per 21 CFR 801.109)
P. Costello
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number
4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-870-7402