(72 days)
None
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.
Yes
The intended uses listed, such as "Stroke Rehab by Muscle Re-education," "Relaxation of Muscle Spasms," and "Increase local blood circulation," are all related to treating or managing medical conditions, which falls under the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section lists therapeutic applications like "Stroke Rehab by Muscle Re-education," "Relaxation of Muscle Spasms," and "Increase local blood circulation," rather than diagnostic purposes such as identifying or characterizing a disease.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses (Stroke Rehab, Muscle Re-education, Relaxation of Muscle Spasms, etc.) are all related to physical therapy and rehabilitation, directly interacting with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), which is the core function of an IVD. The device description is "Not Found," but the intended use strongly suggests a non-IVD device.
IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's intended use clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion
Product codes
IPF, HCC
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Mr. Thomas Sandgaard President Dan Med, Inc. 4 West Dry Creek Circle Suite 260 Denver, Colorado 80120
Re: K012885
Trade/Device Name: NeuroMove NM900 Regulation Number: 890.5850, 882.5050 Regulation Name: Powered muscle stimulator Biofeedback devices Regulatory Class: II
Product Code: IPF, HCC Dated: August 25, 2001 Received: August 28, 2001
Dear Mr. Sandgaard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the casordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is elassined (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additions, 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 I lease be advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a coregulations administered by other Federal agencies. You must or any I cacal statutes and registements, including, but not limited to: registration and listing (21 compry with an the Net 8 requirements (1); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality byevelily (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Mr. Thomas Sandgaard
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification. THC PDA miding of backandary ------------------------------------------------------------------------------------------------------------------------to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific advice to: your vitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 607.10 for his raily, for questions on the promotion and advertising of Compliance at (301) 594-4657. Ticalities of Compliance at (301) 594-4639. Also, please note the your device, picaso ochare and reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misorananing of Telection of the Act may be obtained from the Other general information on your responsional 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,
Susan Walk, us
Image /page/1/Picture/5 description: The image contains a handwritten script. The script appears to be cursive. The letters 'f' and 'w' are clearly visible in the image.
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
2
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NOV 0 82001
Page 1 of 1
KO12885 510(k) Number (if known):
Device Name:
NeuroMove NM900
Indications for Use:
Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education 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)
Prescription Use X .
OR
Over-The-Counter Use
Susan Walk
Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012885