(87 days)
Not Found
Not Found
No
The summary describes a device for electrical muscle stimulation and pain management, listing various stimulation modes and intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the electrical stimulation parameters and their therapeutic effects.
Yes
The device is intended for various therapeutic uses, including muscle spasm relaxation, atrophy prevention, increasing blood circulation, pain relief, and preventing venous thrombosis, as indicated in its intended use.
No
The "Intended Use / Indications for Use" section describes therapeutic purposes such as muscle relaxation, pain relief, and prevention of disuse atrophy. It does not mention diagnosis or detection of diseases.
No
The intended use describes electrical stimulation therapies (VMS, Russian, Monophasic Hi-Volt, Microcurrent, Interferential, Premodulated). These therapies inherently require hardware to deliver the electrical current to the patient. The summary does not mention any software-only functionality that would achieve these therapeutic effects without a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to therapeutic applications on the human body (muscle stimulation, pain relief, etc.). IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts directly with the patient's body.
- No mention of specimen analysis: There is no indication that this device analyzes any biological samples.
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
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 1
For Microcurrent. Interferential and Premodulated
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Product codes
GZJ, LIH, IPF, IMI, IMG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee
Re : K982828 Forte CPS 400 Stim and Forte CPS 200 Stim Trade Names: Product Codes: GZJ, LIH, and IPF K982829 Forte CPS Ultrasound Trade Name: Product Code: IMI K982830 Forte CPS 400 Combo and Forte CPS 200 Combo Trade Names: Product Codes: GZJ, LIH, IPF, IMG, and IMI Regulatory Class: II August 10, 1998 Dated: Received: August 11, 1998
Dear Mr. Elrod:
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, Drug, 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 II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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 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
1
Page 2 - Mr. Joe Elrod
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 requlations.
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,
Colin M. Wittchen, Ph.D., M
Celia 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
CHATTANOOGA GROUP, INC.
STATEMENT OF 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 1
For Microcurrent. Interferential and Premodulated
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off) Division of General Restorative Devices K982828 510(k) Number _
4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: 423-870-2281 Fax: 423-870-7404