(90 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex pattern recognition for diagnosis/treatment planning). The intended uses are standard applications of electrical muscle stimulation.
Yes
The device is intended for medical purposes such as muscle spasm relaxation, prevention of disuse atrophy, increasing blood circulation, muscle re-education, postsurgical stimulation to prevent venous thrombosis, and maintaining/increasing range of motion, all of which fall under the definition of a therapeutic device.
No
The intended uses listed describe therapeutic applications (e.g., muscle relaxation, blood circulation, range of motion, prevention of thrombosis), not the diagnosis of a disease or condition.
Unknown
The provided 510(k) summary 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: The intended uses listed are all related to physical therapy and rehabilitation involving direct interaction with the body (muscle stimulation, range of motion, etc.). IVDs are used to examine specimens (like blood, urine, tissue) outside the body to diagnose or monitor conditions.
- Device Description: While the description is "Not Found," the intended uses strongly suggest a device that applies electrical stimulation or similar physical modalities.
- No Mention of Biological Specimens: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
- Anatomical Site: The mention of "calf muscles" further reinforces that this device interacts directly with the body.
Therefore, the intended uses clearly place this device outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
1.Relaxation of muscle spasms;
2.prevention or retardation of disuse atrophy;
3.increasing local blood circulation;
4.muscle re-education;
5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and
6. 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 for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 1998
Mr. Gary Heiney Universal Technology Systems, Inc. P.O. Box 7908 Jacksonville, Florida 32238-0908
Re: K980346 Trade Name: UTS Electrical Muscle Stimulation Device - PGS 4000 Regulatory Class: II Product Code: IPF Dated: January 20, 1998 Received: January 28, 1998
Dear Mr. Heiney:
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 The general controls provisions of the Act 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 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. T 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. Gary Heiney
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
2
510(k) Number (if known): _ K 980346
Device Name:___PGS-4000
Indications For Use:
APPENDIX E
INDICATIONS FOR USE
1.Relaxation of muscle spasms;
2.prevention or retardation of disuse atrophy;
3.increasing local blood circulation;
4.muscle re-education;
5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
(Division Sign-Off)
Division of General Restorative Devices K980346
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)