(183 days)
Not Found
No
The description focuses on EMG-triggered electrical stimulation controlled by a microprocessor, with no mention of AI or ML algorithms for signal processing, decision making, or adaptation.
Yes
The device is used for the rehabilitation of stroke victims, helping them relearn motor functions through electrical muscle stimulation, which directly treats a medical condition.
No
The device description indicates that Mentamove utilizes electromyographic signals to guide electrical muscle stimulation for rehabilitation, which is a therapeutic function, not a diagnostic one. While it uses EMG signals, it does not interpret them to diagnose a condition.
No
The device description explicitly states it is a "microprocessor controlled medicotechnical instrument" and provides "electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS")". This indicates the presence of hardware components beyond just software.
Based on the provided information, the Mentamove device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Mentamove's Function: Mentamove is described as a "microprocessor controlled medicotechnical instrument" that uses electromyographic (EMG) signals (electrical signals from muscles) to trigger electrical muscle stimulation. This is a therapeutic device used for rehabilitation, not a diagnostic test performed on a sample.
- Intended Use: The intended use is "rehabilitation of victims of stroke" by helping them "relearn voluntary motor functions." This is a therapeutic application, not a diagnostic one.
Therefore, Mentamove falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Mentamove is indicated for use in the rehabilitation of victims of stroke. It utilizes stroke victims' electromyographic signals to guide the application of electrical muscle stimulation. This stimulation helps stroke victims to relearn voluntary motor functions of the extremities.
Product codes (comma separated list FDA assigned to the subject device)
IPF, HCC
Device Description
Mentamove is a microprocessor controlled medicotechnical instrument that provides electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 040849
510(k) Summary
| Applicant | Cole & Associates
633 Skokie Blvd.
Suite 280
Northbrook, IL 60062 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | pIfR Privat-Institut für Reha-Anwendungen GmbH & Co.
Medizintechnik KG
Frau Klaus
Leinorstr. 2
85757 Karlsfeld |
| Device Name | Mentamove® |
| Common Name | Powered Muscle Stimulator, Biofeedback Device
(per 21 CFR 890.5850 and 21 CFR 882.5050) |
| Summary of Substantial
Equivalence | Mentamove® is substantially equivalent in respect to the
intended use, design and method of operation of the
Neuromove NM900 manufactured by Dan Med, Inc.
(K012885). |
| Device Description | Mentamove is a microprocessor controlled medicotechnical
instrument that provides electromyography (EMG)-triggered
neuromuscular electrical stimulation ("EMS"). |
| Intended Use and
Indications | Mentamove is indicated for use in the rehabilitation of
victims of stroke. It utilizes stroke victims'
electromyographic signals to guide the application of
electrical muscle stimulation. This stimulation helps
stroke victims to relearn voluntary motor functions of
the extremities. |
| Technological
Characteristics | Mentamove is user-friendly with self-explanatory instructions
for use via display and therefore simple for the patient to do
exercises at home, including automatic adjustment of all
practice parameters and simple electrode placement. Optical
signal transmission also facilitates the exercise of the patient.
Mentamove automatically gauges therapeutic advances of the
patient. Mentamove works with amplitude modulated
electrical current of middle frequency convenient for the
patient ("soft" electrical current. physiologically adjusted). |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 - 2004
Cole & Associates C/O Richard O. Wood Bell, Boyd & Lloyd, LLP 70 W. Madison St. Suite 3300 Chicago, Illinois 60602
Re: K040849
Trade/Device Name: Mentamove® Regulation Number: 21 CFR 890.5850 and 21 CFR 882.5050 Regulation Name: Powered Muscle Stimulator and Biofeedback Regulatory Class: Class II Product Code: IPF and HCC Dated: September 21, 2004 Received: September 22, 2004
Dear Mr. Wood:
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.
2
Page 2 - Mr. Richard O. Wood
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction will and w you've begin finding of substantial equivalence of your device to a legally prematice notification. The Pro Promises
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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K040849 510(k) Number
Mentamove® Device Name:
Indications for Use:
Mentamove is indicated for use in the rehabilitation of victims of stroke. It utilizes stroke victims' electromyographic signals to guide the application of electrical muscle stimulation. This stimulation helps stroke victims to relearn voluntary motor functions of the extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Image /page/3/Picture/8 description: This image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form indicates "Prescription Use" with an "X" and includes the text "(Part 21 CFR 801 Subpart D)". The form also includes the text "Division of General, Restorative, and Neurological Devices" and the number "K040849". The document is labeled as "Page 4 of 16" and includes the text "Cole & Associates".