(72 days)
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
Not Found
The provided document is a 510(k) clearance letter from the FDA for the NeuroMove NM900 device. It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth details.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a comparison to existing devices, not necessarily a new clinical trial proving specific performance against set acceptance criteria in a standalone manner.
To provide the requested information, the actual 510(k) submission (which includes the supporting data and analysis) would be required. The document provided is the outcome of that review, not the review itself.
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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.
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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
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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
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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
§ 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).