(90 days)
Not Found
Not Found
No
The summary describes a neuromuscular stimulator with standard indications for use and does not mention any AI or ML capabilities.
Yes
The device is described as a "NEUROMUSCULAR STIMULATOR" with intended uses that include treating medical conditions (e.g., "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," "prevent venous thrombosis") and restoring bodily functions (e.g., "Muscle re-education," "Maintaining or increasing range of motion"). These uses align with the definition of a therapeutic device.
No
The intended uses listed (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, post-surgical stimulation to prevent venous thrombosis, maintaining/increasing range of motion) are all therapeutic or rehabilitative in nature, not diagnostic. A diagnostic device is used to identify or detect a disease or condition.
No
The 510(k) summary describes a "NEUROMUSCULAR STIMULATOR," which is a type of hardware device that delivers electrical impulses. There is no mention of this being a software-only application controlling a separate hardware device.
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 blood circulation, muscle re-education, preventing venous thrombosis, maintaining range of motion) are all related to physical therapy and rehabilitation, directly applied to the patient's body.
- Device Description: The device is described as a "NEUROMUSCULAR STIMULATOR," which is a type of device that delivers electrical impulses to muscles.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
Therefore, the MEDS-4 NEUROMUSCULAR STIMULATOR is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- 1 . Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
- 4 . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
Product codes
IPF
Device Description
MEDS-4 Neuromuscular Stimulator
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 is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
JAN 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Darrel Blomberg President Medical Equipment Device Specialists 32158 Camino Capistrano, Suite A-416 San Juan Capistrano, CA 92675
Re: K023439
Trade/Device Name: MEDS-4 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 vour 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 A Mulhern
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-4 NEUROMUSCULAR STIMULATOR 1022449 (510 (k) #
INDICATIONS FOR USE
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
- 1 . Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
- 4 . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
Mark N. Millersen
Division Sign Off
Restorative
510(k) Number K023439