(90 days)
Not Found
Not Found
No
The document describes a neuromuscular stimulator with standard indications for use and does not mention any AI or ML related terms or functionalities.
Yes
The device's intended uses, such as "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," and "Increasing local blood circulation," are therapeutic in nature.
No
The device's intended uses, such as relaxation of muscle spasms and increasing local blood circulation, are therapeutic in nature, not for diagnosing medical conditions.
No
The device description explicitly states "NEUROMUSCULAR STIMULATOR," which is a hardware device that delivers electrical impulses. The summary does not mention any software-only components or functions.
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 "NEUROMUSCULAR STIMULATOR," which aligns with the in vivo therapeutic uses.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Relaxation of muscle spasms
- Prevention or 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
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
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).
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 the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting hair or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Mr. Darrel Blomberg President Medical Equipment Device Specialists 32158 Camino Capistrano, Suite A-416 San Juan Capistrano, CA 92675
Re: K023446
Trade/Device Name: MEDS-3 Neuromuscular Stimulator Regulation Number: 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: October 11, 2002 Received: October 15, 2002
Dear Mr.Blomberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Darrel Blomberg
This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milbern
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
MEDS-3 NEUROMUSCULAR STIMULATOR 1027446 (510 (k) #_ )
INDICATIONS FOR USE
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
- Relaxation of muscle spasms 1.
-
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation 3 .
- Muscle re-education 4 .
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
Mark N Millen
Division Sign-Division of General, Restorative and Neurological Devices
7106(k) Number K02 3446