(131 days)
Not Found
Not Applicable
No
The document does not contain any mentions of AI, ML, or related concepts, and the device description is for a standard neuromuscular stimulator.
Yes.
The device's stated indications for use, such as "Relaxation of muscle spasms," "Prevention of retardation of disuse atrophy," and "Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis," aim to treat or alleviate medical conditions, which defines it as a therapeutic device.
No
None of the listed indications for use involve diagnosing a condition; they all describe therapeutic or preventative actions.
No
The summary describes a "POWERED MUSCLE STIMULATOR" and "HMS Neuromuscular Stimulator, Model HMS-3". This strongly suggests a hardware device that delivers electrical stimulation, not a software-only 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 stimulating muscles for therapeutic purposes (relaxation, preventing atrophy, increasing circulation, re-education, preventing thrombosis, maintaining range of motion). These are all in vivo applications, meaning they are performed on a living organism.
- Device Description: The device is described as a "Powered Muscle Stimulator." This type of device directly interacts with the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely different.
N/A
Intended Use / Indications for Use
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes
89 IPF
Device Description
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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
Not Found
Key Metrics
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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring a symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing the staff and two wavy lines representing the snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2000
Richard M. Harris President Home Medical Services 9393 Activity Road, Suite F San Diego, California 92126
Re: K994062
Trade Name: HMS Neuromuscular Stimulator, Model HMS-3 Regulatory Class: II Product Code: 89 IPF Dated: March 3, 2000 Received: March 6, 2000
Dear Mr. Harris:
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 enclosures) to legally marketed predicate 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 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.
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Page 2 - Richard M. Harris
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,
Donna R. Lochner.
- A 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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HMS NEUROMUSCULAR STIMULATOR
(510(k) # K994062)
INDICATIONS FOR USE
THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS:
- Relaxation of muscle spasms 1.
- Prevention of retardation of disuse atrophy 2.
-
- Increasing local blood circulation
- Muscle re-education র্ব .
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
s D. Lochner.
General Restorative Devices 510(k) Number K 1940 G Z