(77 days)
Not Found
Not Found
No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities typically associated with these technologies. The intended uses are standard for electrical muscle stimulation devices.
Yes
The device is intended for therapeutic uses such as relaxation of muscle spasm, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, preventing venous thrombosis, and maintaining or increasing range of motion. These are all medical purposes.
No
The "Intended Use / Indications for Use" section lists therapeutic applications such as relaxation of muscle spasm, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, postsurgical stimulation to prevent venous thrombosis, and maintaining or increasing range of motion. None of these indicate a diagnostic function.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use suggests a physical effect (muscle stimulation), which typically requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses (muscle relaxation, preventing atrophy, increasing circulation, muscle re-education, postsurgical stimulation, maintaining range of motion) all relate to treating or affecting the human body directly.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
The intended uses described are characteristic of a physical therapy or rehabilitation device, not a device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Relaxation of muscle spasm.
Prevention of retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.
Product codes
IPF
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
§ 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. James C. Lane CEO, Regulatory Affairs LSI International 8849 Bond Overland Park, Kansas 66214
K984021 Re: MS300 Trade Name: K984113 Trade Name: MS400 Regulatory Class: II IPF Product Code: November 3 and 5, 1998 Dated: November 12 and 17, 1998 Received:
Dear Mr. Lane:
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 (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 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 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 action. In addition, FDA may publish further announcements 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.
1
Page 2 - Mr. James C. Lane
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 Finding of babbeaneral ous 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 requlation (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
the regulation entitled, "Misbranding by reference fo 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.
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
I Device Name: _________ MS300
Indications For Use:
Relaxation of muscle spasm. 1 )
Prevention of retardation of disuse atrophy. 2)
Increasing local blood circulation. 3)
- Muscle re-education. 4)
- Immediate postsurgical stimulation of calf muscles to 5) prevent venous thrombosis.
- Maintaining or increasing range of motion. 6)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcoee
(Divisia Sign-Off)
Division of General Restorative Devices
510(k) Number. K984021
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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